Table 1.

Ongoing clinical trials for conservative surgery for early-stage, low-risk cervical cancer

Trial name	Objective	Trial design	Inclusion criteria	Study arms	Status
ConCerv (NCT01048853) [20]	Evaluate the feasibility of conservative surgery in women with early-stage, low-risk cervical cancer	Prospective, single-arm, multicenter	• FIGO 2009 stages IA2–IB1 cervical carcinoma • Squamous or adenocarcinoma histology • Tumor size ≤ 2 cm • No LVSI • Depth of invasion ≤ 10 mm • Negative imaging for metastatic disease • Negative cone margins	• Conization followed by nodal assessment (fertility preservation) • Conization followed by simple hyst + nodal assessment • “Inadvertent” simple hyst + nodal dissection	Completed and published
GOG 278 (NCT01649089) [42]	Study the physical function and quality-of-life before and after surgery in patients with stage I cervical cancer	Prospective cohort	• Stages IA1–IB1 disease • Squamous, adenocarcinoma, or adenosquamous histology • Tumor size ≤ 2 cm • Depth of invasion on diagnostic path ≤ 10 mm • No evidence of metastasis on imaging	• Cone biopsy and pelvic lymphadenectomy • Simple hysterectomy and pelvic lymphadenectomy	Recruiting
SHAPE (NCT01658930) [25]	Compare pelvic relapse-free survival in patients undergoing simple vs. radical hysterectomy	Randomized clinical trial	• FIGO 2009 stages IA2–IB1 • Adenocarcinoma, squamous, or adenosquamous histology • Tumor size ≤ 2 cm • Depth of invasion ≤ 10 mm or < 50% on MRI • No desire for future fertility	• Radical hysterectomy + pelvic lymph node dissection • Simple hysterectomy + pelvic lymph node dissection	Completed enrollment
CONTESSA (NCT04016389) [41]	Evaluate the safety of neoadjuvant chemotherapy followed by fertility-sparing surgery	Multicenter, prospective, single-arm, phase II trial	• FIGO 2018 stage IB2 cervical cancer with lesions measuring 2–4 cm • Lesion size assessed by pelvic MRI and physical exam • Squamous, adenocarcinoma, and adenosquamous histology • LVSI allowed • Pelvic lymph node dissection ± sentinel lymph node mapping to exclude node-positive patients	• All participants will receive neoadjuvant platinum-based chemotherapy, followed by assessment for response • If responded, undergo trachelectomy • If failed to respond, receive adjuvant treatment with chemotherapy and radiotherapy or have a hysterectomy	Recruiting
IRTA [34]	Compare 4.5-year disease-free survival after open vs. minimally invasive radical trachelectomy	Multicenter, retrospective	• Squamous, adenocarcinoma, adenosquamous histology • Tumor size ≤ 2 cm • Underwent open or minimally invasive (robot or laparoscopic) radical trachelectomy with nodal assessment (pelvic lymphadenectomy and/or sentinel lymph node biopsy)	• Open radical trachelectomy • Minimally invasive radical trachelectomy (laparoscopic or robotic)	Completed and published
PHENIX/CSEM 010 (NCT02642471) [30]	Compare oncological outcomes of sentinel lymph node biopsy with pelvic lymphadenectomy in patients with and without sentinel node metastasis	Multicenter, randomized control trial	• Patient age 18–65 years • Histologically confirmed, untreated stages IA1–IB2 cervical squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma	• All patients will undergo sentinel node biopsy at the start of surgery, which will be sent for frozen section, and then patients are triaged to PHENIX-1 (node negative) or PHENIX-II (node positive) • Within each cohort, randomized in 1:1 ratio of sentinel nodes alone or pelvic lymphadenectomy • Radical hysterectomy performed for all patients	Recruiting