Table 12. Current studies for oligometastatic disease (ClinicalTrials.gov (CTG) as of 2/1/2015).
| CTG NCT# / site | Condition | Name | Purpose | Algorithm | Primary Outcome/Endpoint |
|---|---|---|---|---|---|
| 01859221 University Florida [162] |
Prostate oligometastases | Radiotherapy for OMPC | Phase II study to evaluate outcomes of patients treated with Stereotactic radiation therapy for OMPC | RT | Improved PFS over historic controls. |
| 01777802 Mayo Clinic [163] |
Prostate oligometastases | Monitoring Anti-Prostate Cancer Immunity Following SBRT | Determine if SBRT conditions solid tumors to be favorable to the initiation of robust antitumoral immune responses | Observation following SBRT | Induction of anti-prostate cancer immunity |
| 02020070 MSKCC [170] |
Prostate oligometastases | Ipilimumab, degarelix, + RP in castrate sensitive PC or ipilimumab + degarelix in biochemical recurrent castrate sensitive PC after RP | Assess safety + efficacy of combining HT + immunotherapy in non-castrate resistant PC. Cohort 1: ipilimumab + degarelix pre- and post- RP in newly diagnose OM castrate-sensitive disease. Cohort 2: post definitive local therapy with RP, but with biochemical recurrence | IT, LHRH antagonist + surgery -OR- IT, LHRH antagonist | Undetectable PSA at 12- and 20-mths with non-castrate testosterone. |
| 02264379 Technische U Dresden [165] |
Prostate oligometastases | Percutaneous high-dose RT in OMPC | Evaluate outcomes of patients treated with high-dose radiation using either hypofractionated or normofractionated RT; to establish efficacy + safety | HDRT Hypofraction -Or- Normofraction | Toxicity |
| 01558427 UHosp, Ghent [169] |
Prostate oligometastases | Salvage treatment of active clinical surveillance for OMPC: PhII RCT | To determine if salvage treatment of OMPC with either surgery or RT might postpone the start of ADT | Surgery -Or- RT, Which delays ADT? | ADT-free survival |
| 02192788 Hospital Provincial de Castellon [164] |
Prostate oligometastases | PhII study SBRT as treatment for OMPC | Evaluate effect SBRT for OMPC, regardless of basal treatment received | SBRT | # patients without progression of PC treated by SBRT |
| 02274779 Institut cancerologie de l'Ouest [166] |
Prostate oligometastases | PHII trial salvage RT + HT in OM pelvic node relapses of PC | Assess BC or clinical relapse-free survival at 2yrs of PC with 1–5 OM treated with concomitant HDCRT + HT | RT + HT | BC or clinical relapse-free survival at 2yrs |
| 00544830 Institute CoHMCNC [167] |
Prostate oligometastases | IMRT in treating patients undergoing ADT for mPC | Assess how well IMRT works in pats undergoing ADT for mPC | HT + RT | Time to PSA relapse |
| 00544830 City of Hope Medical Center [168] |
Prostate oligometastases | IMRT in Patients Undergoing ADT for Metastatic Prostate Cancer | Evaluate intensity-modulated radiation therapy works in treating patients undergoing androgen deprivation therapy for metastatic prostate cancer | ADT + IMRT | Time to PSA relapse |
| 01728779 Sidney Kimmel Comprehensive Cancer center [180] |
Oligometastases to lung, liver, bone | Stereotactic Body Radiation With Nelfinavir for Oligometastases | Evaluate efficacy radiosensitizer nelfinavir used concurrently with SBRT | Nelfinavir + SBRT | PFS at 6months |
| 01345539 U Pittsburgh [181] |
Oligometastatic disease | Radiosurgery for OM Disease at Initial Presentation | Evaluate feasibility of radiosurgery for all metastatic sites in OM | SRS | Feasibility SRS/SBRT in OM at initial presentation |
| 02076477 Sichuan Cancer Hospital + Research Institute [158] |
OM stage IV NSCLC | The Optimal Intervention Time of Radiotherapy for OM Stage IV NSCLC | Evaluates optimal time for RT for OM stage IV lung cancer | RT | Short-term effects (response rate using RECIST) |
| 01796288 Wu Jieping Medical Foundation [159] |
OM NSCLC | Radiotherapy in Oligometastatic Non-squamous NSCLC With Clinical Benefits From 2nd Line Erlotinib | Evaluate RT in combination with erlotinib in OM NSCLC | Erlotinib +/− RT | PFS |
| 01345552 >U Pittsburgh [182] |
Recurrent OM disease | Radiosurgery for Patients Recurrent OM Disease | Evaluate feasibility of SRS in recurrent OM disease | SRS | Being able to complete accrual to study |
| 01565837 Comprehensive Cancer Centers Nebraska [177] |
OM Melanoma | Concurrent Ipilimumab and Stereotactic Ablative Radiation Therapy (SART) for OM Unresectable Melanoma | Evaluate if SART + ipilimumab will improve survival in OM melanoma | Ipilimumab + SART | Safety and tolerability |
| 02316002 U Pennsylvania [160] |
OM NSCLC | Phase II Study of Pembrolizumab After Curative Intent Treatment for OM NSCLC | Evaluate how well pembrolizumab works in previously treated OM NSCLC | Pembrolizumab | PFS |
| 01646034 Netherlands Cancer Institute [171] |
OM Breast cancer | High Dose CT in OM Homologous Recombination Deficient Breast Cancer | Studies effect of high-dose alkylating CT versus standard CT in OM breast cancer with recombination deficiency | Carboplatin, thiotepa, and cyclophosphamide versus docetaxel, doxorubicin, cyclophosphamide, carboplatin, paclitaxel, gemcitabine | Event free survival |
| 02228356 Universitair Zeikenhuis Brussel [183] |
Neoplasm metastasis | Non-interventional Observational Study of SBRT for OM Cancer | Investigate if respiration control and improved technique improve local control | SBRT | 1-year local control |
| 01725165 M.D. Anderson Cancer Center [161] |
OM Lung cancer | OM Disease | Learn if surgery or radiation after CT help control NSCLC | +/− local consolidation therapy | PFS |
| 02303366 Peter MacCallum Cancer Center, Australia [172] |
OM breast cancer | Pilot Study SABR for OM Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475 | Assess safety + feasibility of MK-3475 + SABR for definitive treatment of OM breast cancer | SABR + MK-3475 | # of patients who complete treatment; safety |
| 01759238 Universitatsklinikum Hamburg-Eppendorf [193] |
OM CRC metastases | Chemoradiotherapy for Patients With Oligometastatic Colorectal Cancer | Evaluate role of CRT with capecitabine and bevacizumab in OM patients who are neither progressive nor resectable after CT | Capecitabine, bevacizumab and RT | PFS |
| 01282450 Maastricht Radiation Oncology [157] |
Stage IV OM NSCLC | Concurrent and Non-concurrent CRT or RT Alone for OM Stage IV NSCLC | Aim is to improve long term survival in OM NSCLC | RT | OS Note: Study completed |
| 02086721 Maastricht Radiation Oncology [188] |
Solid tumors | Assess Toxicity of Immunocytokine L19-IL2 After SABR OM Solid Tumour | Hypothesis is that the immunocytokine L19-IL2 and RT will synergize to improve OS in OM solid tumors | L19-IL2 + RT | Toxicity |
| 01965223 Trans-Tasman Radiation Oncolog Group [189] |
Cancer metastases to lung | Randomized Phase II Study SABR Metastases to the Lung | Determine safety of SABR versus SRS for OM to lung | Multi-fraction SABR and single fraction SABR | Toxicity |
| 02107755 Ohio State U Comprehensive Cancer Center [178] |
Metastatic melanoma | Stereotactic RT and Ipilimumab in Metastatic Melanoma | Determine if stereotactic radiosurgery + ipilimumab kills more tumor cells by causing additional melanoma antigens to be presented to immune system, | Ipilimumab + stereotactic radiosurgery | PFS |
| 01446744 Lawson Health Research institute [190] |
Metastatic tumors | SABR for Comprehensive Treatment of OM Tumors | Compare SABR with CT and conventional RT to assess impact on OS and Q of L | SABR versus palliative RT | OS |
| 02264886 Washington U School of Medicine [191] |
Central thorax cancer, liver cancer, or non-liver abdominal cancer | Adaptive MRI-Guided SBRT for Unresectable Primary or OM Central Thorax and Abdominal Malignancies | Assess feasibility of RT using MRI-guided adaptive technique (day by day re-planning while patient is receiving treatment) | MRI guided SBRT | Feasibility of MRI-guided SBRT (treatment can be delivered in <80 minutes for >75% of patients) |
| 01761929 Princess Margaret Hospital, Canada [184] |
OM solid tumors | 5 Fraction SBRT for OM Regimen, for Extra-Cranial OM | Monitor side effects and outcomes from higher doses of RT, while limiting dose to normal tissues (using a 5 day schedule) | RT in 5 fractions | 1 year PFS at index site |
| 02170181 U of Texas SW Medical Center [185] |
Cancer and receiving RT | Prospective Clinical Registry for OM Disease, Consolidation Therapy, Debulking Prior to CT, or Re-Irradiation | Determine trends in patterns of care and outcomes for refinement and justification of this treatment | SBRT | Patterns of care |
| 02089100 Gustave Roussy, Cancer Campus, Grand Paris [173] |
Breast cancer | Trial of Superiority of SBRT in Breast Cancer | Prospectively study role of metastases SBRT with curative intent in de novo OM disease | SBRT versus placebo | PFS |
| 01898962 Rocky Mountain Cancer Centers [186] |
Stage IV or recurrent carcinoma or sarcoma | Definitive Therapy for OM Solid Malignancies | Aggressive treatment to clinically active sites of disease (alone or + systemic therapy) may improve survival | Definitive local treatment (surgery, RT, radioembolization) | OS and disease-specific survival |
| 00463060 Mount Sinai School of Medicine [187] |
Metastatic cancer | Sutent and Radiation as Treatment for Limited Extent Metastatic Cancer | Combine sutent and RT to determine safety and best method of combining the treatments | Sutent + RT | Survival |
| 02231775 M.D. Anderson Cancer Center [179] |
Stage IV melanoma | Combi-Neo Study for Stage IV Melanoma | Compare dabrafenib + trametinib before surgery versus surgery alone | Surgery +/−dabrafenib +/−, trametinib | 1-year relapse-free survival |
| 01781741 Roswell Park cancer Institute [154] |
Stage III-IV NSCLC | SBRT After Surgery in Stage III-IV Non-small Cell Lung Cancer | Evaluate SBRT post lymphadenectomy | Therapeutic lymphadenectomy, SBRT | Toxicity |
| 00776100 North Central Cancer Treatment Group/NCI [156] |
Stage IV NSCLC | RT or Observation After CT in Stage IV NSCLC | Randomized Phase II trial studying how well RT works compared to CT in Stage IV NSCLC | RT versus observation | OS Note: Study completed |
| 00182793 City of Hope Medical Center/NCI [174] |
Breast cancer | Combination CT +/− Trastuzumab Followed By an Autologous Stem Cell Transplant (SCT) and RT in Stage III or IV Breast Cancer | Evaluate combination CT +/− trastuzumab, then autologous SCT and RT | CT+/− Trastuzumab, then SCT + RT | TTP, OS, 5-year response rate, feasibility Note: study completed |
| 01941654 Chinese University of Hong Kong [153] |
NSCLC activating EGFR mutation | ATOM_local Ablative Therapy | Efficacy of local ablative therapy in NSCLC with activating EGFR mutation with active OM disease after 1st line TKI EGFR | Local ablative RT | PFS at 1-year |
| 01185639 Comprehensive Cancer Center Wake Forest U [155] |
NSCLC | SBRT in Metastatic NSCLC | Evaluate feasibility, safety, and efficacy of SBRT after 4cycles 1st line CT | SBRT | PFS |
| 01763970 Sidney Kimmel Comprehensive Cancer Center [194] |
Pediatric sarcoma | SBRT for Pediatric Sarcomas | Evaluate efficacy of SBRT (5 fractions) in pediatric sarcoma | SBRT | SBRT efficacy |
| 01875666 UNC Lineberger Comprehensive Cancer Center [175] |
Breast neoplasm | Defining the HER2 Positive (+) Breast Cancer Kinome Response to Trastuzumab (T), Pertuzumab (P), Combination Trastuzumab +Pertuzumab (T+P), or Combination Trastuzumab + Lapatinib (T+L) | Evaluate kinome response in Stage I-IV HER2+ scheduled to undergo definitive therapy for OM disease | Randomized to T, P, T+P, or T+L | Difference in kinome activation pre- and post-treatment |
| 01706432 U of Chicago / NCI [176] |
Stage IV breast cancer | Hypofractionated IGRT in Stage IV Breast Cancer | Studies hypofractionated IGRT in stage IV breast cancer | Hypofractionated RT | Feasibility of correlating number of circulating tumor cells with TTP in metastatic breast cancer |
| 01347333 St. John's Mercy Research Institute, St. Louis [192] |
Liver metastases, hepatocellular carcinoma, intrahepatic cholangiocarcinoma | SBRT for Liver Tumors | Evaluate local control rate of SBRT to liver tumors | SBRT | Local tumor recurrence rate |
Abbreviations: OMPC = oligometastatic prostate cancer; RT = radiation therapy; PFS = progression free survival; SBRT = stereotactic body radiation therapy; RP = retropublic prostatectomy; PC = prostate cancer; HT = hormone therapy; OM = oligometastatic; IT = immunotherapy; LHRH = luteinizing hormone-releasing hormone; PSA = prostate specific antigen; HD = high dose; RCT = randomized controlled trial; ADT = androgen deprivation therapy; BC = biochemical; IMRT = image guided radiation therapy; PFS = progression free survival; SRS = stereotactic radiosurgery; CRT = chemoradiation therapy; RECIST = response evaluation criteria in solid tumors; NSCLC = non-small cell lung cancer; CT = chemotherapy; OS = overall survival; SABR = stereotactic ablative radiation therapy; MRI = magnetic resonance imaging; SCT = stem cell transplant; TTP = time to progression; ATOM = ablative therapy oligometastases; EGFR = epidermal growth factor receptor; Q of L = Quality of Life