Minimally Invasive Radical Hysterectomy Using Endoscopic Stapler in Stage IB2 or IIA1 Cervical Cancer (SOLUTION2)

Seoul National University

Status: Not yet enrolling

Conditions: Cervical Cancer Stage IIa; Cervical Cancer Stage IB2

Treatments: Device: Open radical hysterectomy; Device: Minimally invasive radical hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07256977

SOLUTION2

0620202330 (Other Grant/Funding Number)

Details and patient eligibility

About

This study is a multicenter, open-label, non-inferiority, randomized controlled, investigator-initiated clinical trial comparing the efficacy and safety of open radical hysterectomy versus minimally invasive radical hysterectomy using an endoscopic stapler as surgical treatments for early cervical cancer.

Full description

This study exclusively includes patients with stage IB2 or IIA1 cervical cancer who have tumors measuring 2 cm or larger but less than 4 cm. After randomization, one group undergoes radical hysterectomy via open surgery, while the other group undergoes minimally invasive radical hysterectomy using an endoscopic stapler. This approach using an endoscopic stapler aims to prevent intraoperative exposure of tumor cells to the abdominal cavity, comparable to open surgery, thereby enabling a comparison of therapeutic efficacy and safety.

Enrollment: 494 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

I. Inclusion Criteria:

1. 2018 FIGO stage IB2 or IIA1 cervical cancer (tumor maximum diameter ≥2 cm and <4 cm)

2. Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma

3. Planned for Type B or C radical hysterectomy

4. With adequate bone marrow, renal, and hepatic function

   • WBC >3.0 × 10⁹ cells/L
   • Platelets >100 × 10⁹ cells/L
   • Creatinine <180 μmol/L
   • Bilirubin <1.5 × normal range
   • AST, ALT < 3 × normal range

5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

6. Previous history of other invasive malignancies with no evidence of recurrence for at least 5 years

7. Signed and approved consent form

II. Exclusion Criteria:

1. Histological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma

2. Tumor size less than 2 cm classified as 2018 FIGO stage IA1, IA2, or IB1 disease

3. The following are observed on preoperative CT or MRI

   • Tumor size ≥4 cm
   • Lymph node metastasis (short axis ≥15 mm)
   • Paracervical invasion
   • Bladder or rectal invasion
   • Distant metastasis

4. Prior pelvic or abdominal radiotherapy

5. Prior neoadjuvant chemotherapy before surgery

6. Unsuitable for surgery due to severe systemic disease at the investigator's discretion

7. Difficult to consider intraoperative lymphatic mapping due to

   • Allergy to triphenylmethane compounds
   • History of prior retroperitoneal surgery
   • History of prior pelvic radiotherapy
   • Cases where cold knife or loop electrosurgical excision procedure (LEEP) was performed within 4 weeks prior to study participation
   • Allergy to triphenylmethane compounds

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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494 participants in 2 patient groups

Open radical hysterectomy

Experimental group

Description:

Radical hysterectomy is performed via open surgery

Treatment:

Device: Open radical hysterectomy

Minimally invasive radical hysterectomy

Experimental group

Description:

Radical hysterectomy is performed via minimally invasive surgery

Treatment:

Device: Minimally invasive radical hysterectomy