Abstract
Objectives:
Advances in radiation (RT) treatment planning enhance the need for uniform quality oversight on clinical trials. NRG GY-017 was a randomized trial of the anti-program ligand death 1 (PD-L1) antibody, atezolizumab, before and concurrent (arm A) or concurrent with chemoradiaton (arm B) for locally advanced cervical cancer. We describe the prospectively collected pretreatment RT quality and workflow.
Methods:
Forty patients were consented and randomized. Thirty-seven patients submitted pretreatment RT plans for central review, and 36 patients ultimately received protocol therapy. Intensity modulated radiation therapy (IMRT) contouring guidelines and dose specifics were outlined in the protocol, with volume and dose deviations specified as per protocol, minor and major variation. Each site had to pass a standardized IMRT credentialing process. Sites were required to submit an IMRT plan for physician expert contour target and organ-at-risk review in a rapid pretreatment manner. An expert physician then scored the contours and plan as per protocol or as a deviation. For major deviations, the sites were required to revise and resubmit the plans, which were then re-reviewed prior to protocol start.
Results:
The median follow-up time was 20 months. Thirty-seven participants had a central expert review of the pretreatment external beam radiation therapy plan. Thirteen plans (35%) were scored as a major deviation requiring revision: 11 secondary to contours (5 bowel and 6 nodal volumes) and 2 secondary to incorrect expansion on the volume or the dose distribution. The major deviation plans were resubmitted; however, 2 of them required revisions for a total of 3 plans. Because of the quality review, all patients had per-protocol scores prior to the treatment administration.
Conclusions:
Our data indicate that 35% of the baseline submitted advanced technology IMRT plans required revision and resubmission in order to meet protocol standards. RT plan quality workflow continues to evolve with advanced techniques and has implications in clinical trial review. Pretreatment plan review is an important quality measure for cervical cancer clinical trials.
Introduction
Quality assurance (QA) in radiation oncology plays a critical role in ensuring safe and effective treatment delivery. In locally advanced cervical cancer, external beam radiation therapy (EBRT) with concurrent chemotherapy followed by brachytherapy is the cornerstone of treatment. Given the complexity of treatment planning and delivery, rigorous QA measures are essential to optimize outcomes and minimize treatment-related toxicities.1
Clinical trials in gynecologic cancers serve as pivotal platforms for evaluating new radiation techniques, combination therapies, and protocol adaptations. The integrity of these trials depends heavily on the consistency and accuracy of radiation delivery across multiple institutions. Radiation QA, particularly in the form of centralized and standardized plan reviews, helps ensure that treatment plans meet protocol-defined criteria and adhere to dosimetric and anatomic guidelines. Without these QA safeguards, variation in contouring, planning, and dose distribution may introduce bias and diminish the validity of trial outcomes.2,3
The rationale for implementing QA in clinical trials is further strengthened by evidence from cooperative group studies demonstrating a correlation between protocol compliance and improved clinical outcomes. QA reviews facilitate early identification of deviations, enable timely corrections, and promote adherence to high-quality treatment standards across sites. Despite these benefits, there remain limited data specifically addressing the implementation and effectiveness of pretreatment external beam QA in gynecologic cancer trials, highlighting an urgent need for systematic integration of QA protocols in this setting.4
Radiation QA is essential in multi-institutional clinical trials to ensure consistent protocol implementation across participating sites. In cervical cancer, EBRT planning requires complex target delineation and adherence to strict dosimetric constraints, particularly when advanced techniques such as intensity modulated radiation therapy (IMRT) are used. Variability in contouring and treatment planning can introduce heterogeneity in treatment delivery that may compromise trial integrity and interpretation of outcomes.
Although the importance of radiation QA in clinical trials has been previously described, prospective evaluations of real-time centralized QA workflows in gynecologic oncology trials remain limited. NRG-GY017 incorporated a rapid centralized pretreatment radiation review process within a modern immunotherapy−chemoradiation trial for locally advanced cervical cancer. The goal of this study was to prospectively evaluate the workflow, feasibility, and frequency of deviations identified through this QA process. This analysis provides practical insight into the implementation of centralized and pretreatment radiation review in multi-institutional clinical trials using contemporary radiation techniques.
Methods
Study population
This research complies with all relevant ethical regulations and received central institutional review board and institutional approval for the NRG Oncology network sites that participated. Written informed consent was obtained from all participants: University of California San Diego institutional review board (IRB), Augusta University IRB, University of Oklahoma IRB, University of Pittsburgh IRB, Ohio State University IRB, Women and Infants Brown University IRB, Medical College of Wisconsin IRB, University of Alabama IRB, Thomas Jefferson University IRB, Memorial Sloan Kettering IRB. The study, NRG-GY017 (NCT03738228), was authorized, and the study design complied with all relevant regulations regarding the use of human subject participants and was conducted in accordance with the criteria set by the Declaration of Helsinki. NRG-GY017 opened on October 26, 2018 and closed to accrual on June 11, 2020. The first patient was enrolled on January 7, 2019, and the last patient was enrolled on June 11, 2020.
Patients with confirmed locally advanced cervical cancer (squamous, adenocarcinoma, or adenosquamous) with International Federation of Gynecology and Obstetrics (FIGO) 2009 stages IB2/IIA with positive paraortic lymph node or IIB/IIIB/IVA with positive pelvic and/or paraortic lymph node were eligible.
Pretreatment imaging, including pelvic magnetic resonance imaging and positron emission tomography/computed tomography, was recommended to guide target delineation and staging per protocol. When available, magnetic resonance imaging and/or positron emission tomography/computed tomography imaging were coregistered with the planning computed tomography to assist with accurate tumor and nodal delineation. A bladder filling protocol was recommended to improve reproducibility of pelvic anatomy during simulation and treatment; however, specific bladder preparation and bowel management practices were implemented according to institutional standards.
Treatment
NRG-GY017 is a 2-arm, open-label randomized (1:1) prospective phase 1 trial with 2 experimental arms; arm A: intravenous atezolizumab 1200 mg every 3 weeks neoadjuvant and concurrent with chemoradiaton (days −21, 0, and 21); arm B: atezolizumab concurrent with chemoradiaton (days 0, 21, and 42) using block randomization from the NRG statistical office without blinding. Patients were enrolled in a consecutive manner with phase 1 NRG Oncology gynecologic oncology sites, with a safety monitoring rule dictating a study hold in the event of dose-limiting toxicities observed in more than 30% of dose-limiting toxicity−evaluable patients in either one arm. Patients received IMRT-based extended-field radiation therapy with concurrent weekly cisplatin followed by brachytherapy to achieve a total dose of ~80 to 90 Gy equivalent dose in 2Gy to the high-risk clinical target volume.
Gross tumor volume included the primary cervical tumor and any radiographically involved lymph nodes identified on diagnostic imaging. Clinical target volume encompassed the cervix, uterus, parametria, upper vagina, and regional nodal basins including pelvic and paraortic lymph nodes as appropriate per protocol. Planning target volume was generated by applying specific margins to account for setup uncertainty and organ motion. EBRT was delivered using IMRT or volumetric modulated arc therapy techniques to a dose of 45 to 50 Gy in 1.8 to 2 Gy fractions to the pelvis, with simultaneous integrated boost to involved lymph nodes to 50 Gy and then to total doses of 54 to 58 Gy, as reflected in Tables 1 and 2.
Table 1.
Target volume dose constraints and protocol specifications
| Structure | Dosimetric parameter | Per protocol | Variation acceptable | Deviation unacceptable |
|---|---|---|---|---|
| PTV_4500 | D95% (Gy) | ≥45 | ≥43.65 | <43.65 |
| D97% (Gy) | ≥43.65 | ≥40.5 | <40.5 | |
| D0.03cc (Gy) | ≤51.75 | ≤54 | >54 | |
| PTV_5000 | D95% (Gy) | ≥50 | ≥48.50 | <48.50 |
| D97% (Gy) | ≥48.50 | ≥45 | <45 | |
| D0.03cc (Gy) | ≤57.5 | ≤60 | >60 | |
| PTV_5400 | D95% (Gy) | ≥54 | ≥52.4 | <52.4 |
| D97% (Gy) | ≥52.4 | ≥48.6 | <48.6 | |
| D0.03cc (Gy) | ≤62.10 | ≤64.8 | >64.8 | |
| PTV_5800 | D95% (Gy) | ≥58 | ≥55.1 | <55.1 |
| D97% (Gy) | ≥56.2 | ≥52.2 | <52.2 | |
| D0.03cc (Gy) | ≤66.7 | ≤69.6 | >69.6 |
Abbreviation: PTV = planning target volume.
Table 2.
Target volume/oragan at risk contouring review form
| TV/OAR contouring review form | ||
|---|---|---|
| Study # | GY017 | |
| Site # | ||
| Case # | ||
| Arm | ||
| Modality | IMRT | |
| Review timepoint | Pretreatment | |
| No. of reviews required | ||
| Structure | Comments | Score |
| GTV_4500 | ||
| CTV_4500 | ||
| CTV_5000 | ||
| CTV_5400 | ||
| CTV_5800 | ||
| ITV_4500 | ||
| PTV_4500 | ||
| PTV_5000 | ||
| PTV_5400 | ||
| PTV 5800 | ||
| External | ||
| NonPTV4500 | ||
| Bowel Space | ||
| Rectum | ||
| Bladder | ||
| BoneMarrow | ||
| BoneMarow_Act | ||
| Femur_L | ||
| Femur_R | ||
| Other | ||
| Overall TV Score | ||
| Overall OAR Score | ||
| Overall TV-OAR Score | ||
Abbreviations: CTV = clinical target volume; GTV = gross tumor volume; IMRT = Intensity modulated radiation therapy; OAR = organs at risk; PTV = planning target volume; TV = tumor volumes.
All treated patients completed radiation therapy within the protocol-specified treatment duration of 56 ± 3 days.
Radiation QA process
All sites had to complete and pass an NRG Oncology RT QA IMRT phantom physics credentialing process and a benchmarking case. All IMRT plans had a pretreatment rapid review for RT quality.
IMRT contouring guidelines and dose specifics were outlined in the protocol, with deviations specified as per protocol, minor, and major for the normal organs at risk, as shown in Table 3, and target volume dose specification, as shown in Table 1. Sites were required to submit a pretreatment IMRT plan for physician expert contour target and organ-at-risk review in a rapid pretreatment manner, which was defined as at least 3 days prior to treatment start.
Table 3.
Normal tissue dose constraints per-protocol specifications
| Structure | Dosimetric parameter | Per protocol | Variation acceptable | Deviation unacceptable |
|---|---|---|---|---|
| Bladder | D50% (Gy) | ≤45 | ≤55 | >55 |
| D0.03cc (Gy) | ≤52 | ≤57.5 | >57.5 | |
| Rectum | D50% (Gy) | ≤45 | ≤54 | >54 |
| D0.03cc (Gy) | ≤50 | ≤55 | >55 | |
| Bowel | D35% (Gy) | ≤35 | ≤50 | >50 |
| D0.03cc (Gy) | ≤60 | ≤66 | >66 | |
| Femurs | D15% (Gy) | ≤30 | ≤50 | >50 |
| D0.03cc (Gy) | ≤50 | ≤55 | >55 | |
| Bilateral kidneys | D50% (Gy) | ≤18 | ≤20 | >20 |
| Liver | D50% (Gy) | ≤25 | ≤30 | >30 |
| Duodenum | D50% (Gy) | ≤40 | ≤50 | >50 |
| D0.03cc (Gy) | ≤56 | ≤60 | >60 | |
| Spinal cord | D0.03cc (Gy) | ≤45 | ≤47.5 | >47.5 |
The site was required to submit the contours to the NRG centralized QA entity (Imaging and radiation oncology core [IROC]), and then a prespecified group of physician experts was alerted and one was assigned the case to score and assess within 24 to 48 hours. At the same time, the generated plan was submitted to IROC for dosimetric scoring of the plan, and this was given to the medical doctor reviewer. A scorecard system was used when evaluating the tumor volumes, normal tissue contours, and doses. For contours, score 1 was consistent per protocol. Score 2 is a minor deviation felt not to affect the potential outcomes of the study but deviated from the protocol, and score 3 is a major deviation from the protocol where endpoints may be affected. In the protocol, the dose variations were listed as per protocol, minor variation, and major variation. The medical doctor reviewer then scored the contours as per protocol, minor, or major deviation based on the protocol scorecard. For major deviations, the sites were required to revise and resubmit the plans, which were then re-reviewed prior to protocol start.
Written comments were sent to the site and principal investigator radiation oncologist. If the review showed a major deviation in the contours or the planning doses, the plan needed to be resubmitted prior to the patient being treated. The contour review form is shown in Table 2.
Results
The median follow-up time was 20 months. Patient demographics have been previously reported.5 Thirty-six of the 40 patients were treated per protocol and followed for the study endpoints, with 37 patients reviewed for RT QA. Arm A had an EBRT dose reported by the site dose summary per protocol of 89%, and arm B had 100%.5 Thirty-seven participants had central review of the pretreatment EBRT plan, which included 1 patient ultimately not treated on the study. The overall contour and treatment planning workflow of the submission QA process is shown in Figure 1. There were 6 expert physician reviewers who participated in the pretreatment review, including the principal investigator of the trial. Figure 2 shows an illustration of a pelvic contour per protocol with the target volume of the cervix and the margin for the planning target volume shown. Figure 3 shows an example of a lymph node contour that had an inappropriate contour per the protocol because of omission of the external iliac nodes and required revision.
Fig. 1.
RT quality assurance workflow. Abbreviations: PI = principal investigator.
Fig. 2.
Sample contours. Abbreviations: CT = computed tomography; CTV = clinical target volume; GTV = gross tumor volume; L = Left; PEL = Pelvis; PTV = planning target volume; PRV = not significant; R= right.
Fig. 3.
Sample contour that needed revision as the external iliac lymph nodes were not contoured. Abbreviations: L= left; R = right.
Using the scorecard, 13 plans (35%) were scored as a major deviation requiring revision: 11 secondary to physician contours (5 bowel and 6 LN) and 2 secondary to incorrect expansion of the contours or the dose. The major deviation plans were resubmitted; however, 2 of the resubmissions required revisions for a total of 3 plans. Eventually, all plans passed the RT QA portion prior to the patient being treated.
The brachytherapy QA on this trial has been reported previously.6
Discussion
Within cooperative groups such as NRG Oncology, credentialing practices for radiation therapy in clinical trials typically include institutional physics verification using IMRT phantom testing and benchmark planning exercises. Although these processes confirm a site’s technical capability to deliver advanced radiation techniques, they do not necessarily ensure consistent execution at the patient level for protocol compliance. Personnel variability within institutions represents an additional challenge because the physician completing credentialing exercises may differ from the treating physician responsible for contouring and planning. To mitigate variability in target delineation and treatment planning, NRG-GY017 incorporated a rapid centralized pretreatment review of contours and dose distribution. Although this process enabled timely feedback and ensured protocol alignment before treatment initiation, it also required substantial coordination and expert reviewer effort of the NRG study team.
Approximately 35% of submitted EBRT plans contained major deviations requiring revision prior to treatment initiation. Most deviations involved lymph node or bowel contouring. Nodal contour errors frequently occurred in the paraortic region or involved omission of portions of the nodal target volume, highlighting the complexity of extended-field target delineation in cervical cancer. Although these deviations were corrected before treatment, their frequency underscores the value of centralized QA review even among credentialed institutions.
Although the present analysis was not designed to assess clinical outcomes, prior cooperative group studies have demonstrated that radiation protocol deviations are associated with inferior outcomes and increased toxicity.2,3 Despite this, data specifically examining external beam radiation QA workflows in gynecologic oncology trials remain limited. Studies in other disease sites have shown that real-time centralized plan review and peer review processes can reduce protocol deviations and improve treatment consistency.7,8 Similar approaches in gynecologic cancers have demonstrated that centralized review improves contouring consistency and reduces geographic miss in multi-institutional trials.9
A major challenge in implementing centralized QA workflows is the labor intensity associated with rapid plan review. Multidisciplinary evaluation by radiation oncologists, physicists, and dosimetrists must often occur within a short time window to avoid delays in treatment initiation. As radiation techniques continue to evolve, scalable QA strategies will become increasingly important. Emerging approaches include automated contour feedback systems, knowledge-based planning tools, and artificial intelligence−assisted QA platforms.
Taken together, these findings demonstrate that centralized pretreatment radiation QA review is feasible and frequently identifies clinically meaningful deviations even among experienced institutions. Continued development of efficient and scalable QA workflows, including integration of automated tools, will be important for maintaining treatment consistency and protocol adherence in future multi-institutional cervical cancer trials.
The following intervals are proposed options for expert QA assessments in the pretreatment QA review setting:
1. Pretreatment review on selected cases
Before radiation therapy begins, an initial expert review should be conducted to verify contouring accuracy, dose distribution, and compliance with trial protocols. This review ensures that any necessary modifications are made before treatment initiation. This could be accomplished on every case, or considerations for the first 3 cases from a new site, or a time interval for pretreatment review such as one case every 6 months during enrollment for a quality check.
2. Pretreatment review only on 1 case per site
When a new clinical trial site is added, expert QA should be conducted on an initial case to ensure institutional compliance with standardized protocols before full patient enrollment. This step mitigates variations in treatment delivery across different trial locations.
3. Rapid pretreatment review on every case
This is the most labor-intensive, and may not necessarily be needed once a site “learns” the protocol or after a certain number of cases.
Implementing a structured QA workflow in clinical trials has been associated with improved treatment adherence and patient outcomes. Studies have demonstrated that radiation protocol deviations are linked to decreased survival rates and increased toxicity.2 A standardized QA workflow ensures that protocol violations are minimized, leading to higher control rates, reduced treatment toxicity, increased reproducibility of clinical trial results, and faster trial completion due to reduced protocol deviations and improved consistency. On future cervical cancer clinical trials with the NRG Oncology network, we plan to use artificial intelligence to augment the expert review, and this software is being developed by the radiation oncology quality core.
The most frequent deviations involved bowel and lymph node contours. Nodal contouring errors most commonly occurred in the paraortic region or involved omission of nodal target volumes. These deviations likely reflect the inherent complexity of nodal target delineation in extended-field IMRT as well as variability in interpretation of consensus contouring guidelines. Similarly, bowel contour deviations may arise from differences in institutional practices regarding small bowel bag delineation and planning organ-at-risk volume definitions. These findings may be particularly relevant in the context of simultaneous integrated boost techniques, where involved lymph nodes receive higher radiation doses and are often located in close proximity to bowel structures. Inaccurate nodal contouring in this setting may result in either under-coverage of target volumes or increased dose to adjacent organs at risk, underscoring the importance of precise contour delineation and centralized QA review.
Several limitations should be acknowledged. First, this analysis included a relatively small sample size (n = 36) from a phase 1 trial and was restricted to NRG phase 1 institutions with established radiation QA infrastructure, which may limit generalizability to lower-resource settings or noncooperative group environments. In addition, the reliance on expert physician review without formal assessment of interobserver concordance may introduce variability in contour evaluation, and the involvement of the study principal investigator in some reviews could introduce potential bias, although standardized protocol scorecards were used to promote consistency. Finally, because this analysis was descriptive and not designed to evaluate clinical outcomes, potential clinical impacts are hypothesis-generating, and the study was not powered to assess variation across sites or reviewers.
Conclusion
Pretreatment radiation plan review represents an important QA mechanism for multi-institutional cervical cancer trials by ensuring protocol adherence and treatment plan consistency.
Supplementary Material
Supplementary material associated with this article can be found, in the online version, at doi:10.1016/j.ijrobp.2026.04.102.
Disclosure:
D.Z.’s institution received grants/contracts from AstraZeneca, Merck, Plexxikon, Volastra, Synthekine, and Xencor. He received royalties paid to himself from Merck. He also received consulting fees from AstraZeneca, Gilead, GSK, Astellas, Xencor, DaiichiSankyo, Memgen, Hervolution, and Everest. He has stock/stock options from Accurius Therapeutics, Calidi Biotherapeutics, and Immune Therapeutics. J.P.C. received consulting fees from Stryker and Guidepoint (both completed). He also received a stipend for writing a review article (completed) from the GOG Foundation. He participated in DSMB (ongoing) from Kortuc LLC and LadeRx LLC (ongoing) as well as serving on an advisory board from Merck (completed). He is also a board member (uncompensated) for the American Brachytherapy Society. J.L. received funding to perform quality assurance work from grant U24CA180803. S.G. received payment from GSK for speakers’ bureau. C.M. received research funding to her institution from the NCI. She also received grants/contracts from Decipera, Astellas, Pharma, Seagen, Genmab, EMD Serono, Merck, Regeneron, Moderna, AstraZeneca, AvengeBio, Zentalis, GlaskoSmithKline, Novocure, Immunogen, Elucida, Roche/Genentech, Pfizer, Laekna, Artios, Volastra, AADi, ProfoundBio, and REPARE outside the submitted work. She received support from the GOG Foundation and GSK for attending meetings and/or travel. She also participated on a DSMB for REPARE. C.A.L. received grants from the NIH (UG1 233330 and P50 CA098252). Dr R.O.’s institution received research funding from Acrivon Therapeutics, ArsenalBio, AstraZeneca/MSD, Atara Biotherapeutics, Bristol Myers Squibb, Context Therapeutics, Debiopharm, Genentech, Genmab, GOG Foundation, GSK, Juno Therapeutics/Celgene/Bristol Myers Squibb, Kite/Gilead Sciences, Ludwig Institute for Cancer Research, Lyell Immunopharma, Marker Therapeutics (previously known as Taplmmune), MSD/Genentech, Mural Oncology, OnCusp Therapeutics, Regeneron, SELLAS Life Sciences Group, Syndax, TCR2 Therapeutics/Adatimmune. She also received consulting fees from 2seventy bio, ImmunoGen/AbbVie, GOG Foundation, GSK, LOXO Oncology/Lilly, Miltenyi Biotec, Regeneron, and Seagen/Genmab/Pfizer. She received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Aptitude Health, Curio Science, MJH Life Sciences Physicians’ Education Resource, GOG Foundation and GSK. She received support for attending meetings and/or travel from Gathering Around Cancer and SGO. Other financial or non-financial interest include JAMA Oncology. C.A. received clinical trial funding to her institution (MSK) from AbbVie − MSK PI, GOG 3005; Clovis − MSK PI; ARIEL 2 and 3; Genentech/Roche − MSK PI, GOG 3015 (Imagyn050); Artios − MSK Co-PI, ARTIST; AstraZeneca − MSK PI, SOLO1/GOG 3004; National Coordinating Investigator & MSK PI, D081RC00001; ENGOT-ova46; AGO-OVAR 23; GOG 3025. She participated on a DSMB or advisory board for WCG − DMS 4/26/23 − conflict of interest summary ongoing; AstraZeneca − future clinical strategies for endometrial cancer virtual advisory board 3/13/24; AstraZeneca − external science panel: future clinical strategies for ovarian cancer, specifically focused on the role of ADCs in future treatment 6/13/24; Merck − global cervical and ovarian cancer virtual advisory board 7/10/23. She is on the board of directors (unpaid) for the GOG Foundation as well as board of directors (unpaid) for NRG Oncology. R.S. received consulting fees to her-self from Incyte and served as Chair, IDSMB for Celsion. She also participated on a DSMB for Celsion (as above as well as Eisai [DSMB]). J.M. received grants paid to her institution (R50CA282102-01 and R01C276087). She received royalties or licenses from Springer for Brachy Handbook. She received consulting fees from Varian Medical Systems, Merck, Primmune and AstraZeneca (payment to institution). She received payment for expert testimony on a case. She received support for attending meetings and/or travel from Merck (advisory board November 2024). She has a patent for US Patent vaginal dilatation system. She also served as leadership or fiduciary role on the board of directors − GOG Foundation, a brachy society. All other co-authors have no conflicts of interest to declare. This study was supported by the National Cancer Institute grants to NRG Oncology U10CA180822 (NRG Oncology Statistics and Data Management Center), U10CA180868 (NRG Oncology Operations), U24CA196067 (NRG Oncology Biospecimen Bank), and U24CA180803 (IROC Operations). NRG-GY017 was sponsored by the National Cancer Institute (NCI) and was conducted by NRG Oncology under a Cooperative Research and Development Agreement between the NCI and Genentech. D.Z. is funded in part by the National Institutes of Health/National Cancer Institute Cancer Center Support Grant (P30-CA008748). D.Z. and J.M. received funding from the National Cancer Institute grant (R01CA276087). J.M. received funding from the National Cancer Institute grant (R50CA282102-01). The following NRG Oncology member institutions participated in the primary treatment studies: Georgia Cares Minority Underserved NCORP, UC San Diego Moores Cancer Center, University of Oklahoma Health Sciences Center LAPS, Women and Infants Hospital, Ohio State University Comprehensive Cancer Center LAPS, UPMC Hillman Cancer Center LAPS, and Froedtert and the Medical College of Wisconsin LAPS. This manuscript is the result of funding in whole or in part by the National Institutes of Health (NIH). It is subject to the NIH Public Access Policy. Through acceptance of this federal funding, NIH has been granted the right to make this manuscript publicly available in PubMed Central on the Official Date of Publication, as defined by NIH.
Footnotes
This protocol is registered with ClinicalTrials.gov and may be viewed online at https://clinicaltrials.gov/ct2/show/NCT03738228.
Data Sharing Statement:
Research data are stored in an institutional repository and will be shared uponrequest to the corresponding author.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
Research data are stored in an institutional repository and will be shared uponrequest to the corresponding author.