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

Official title

A Multicenter Non-inferiority Randomized Controlled Trial on Minimally Invasive Radical Hysterectomy Using an Endoscopic Stapler to Prevent Tumor Spillage in Stage IB2-IIA1 Cervical Cancer

Overview

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.

Detailed 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.

Interventions

• Device Open radical hysterectomy
  Radical hysterectomy is performed via open surgery, and Wertheim clamp is used for preventing tumor spillage during colpotomy
• Device Minimally invasive radical hysterectomy
  Radical hysterectomy is performed via minimally invasive surgery, and an endoscopic stapler is used for preventing tumor spillage during colpotomy

Primary outcome measures

• 4.5-year progression-free survival rate [Time frame: Up to 4.5 years after enrollment]

Secondary outcome measures (12)

• Intraoperative complcation rate [Time frame: During surgery]
• Postoperative acute complication rate within 4 weeks [Time frame: Within 4 weeks after surgery]
• Postoperative complication rate after 4 weeks [Time frame: Greater than 4 weeks up to 12 months post-surgery]
• Operation time [Time frame: Peri-procedural]
• Estimated blood loss [Time frame: Peri-procedural]
• Transfusion requirement [Time frame: From the surgical incision to the end of surgery (skin closure)]
• Length of hospitalization [Time frame: From date of hospital admission to date of hospital discharge, assessed up to 30 days.]
• Postoperative pain [Time frame: Assessed at each visit from Visit 2 (2 weeks) and Visit 17 (54 months). The score can range from 0 to 10, with a higher score indicating more severe pain.]
• Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) [Time frame: Assessed at Visit 1(within 4 weeks), Visit 3(2 weeks), Visit 4(6 weeks), Visit 5(3 months), Visit 6(6 months), Visit 10(18 months), Visit 13(30 months), Visit 17(54 months).]
• EQ-5D-5L [Time frame: Assessed at Visit 1 (within 4 weeks), Visit 3 (2 weeks), Visit 4 (6 weeks), Visit 5 (3 months), Visit 6 (6 months). The score ranges from -0.594 to 1.000, showing that higher scores mean healthier.]
• The 12-item Short Form Health Survey (SF-12) [Time frame: Assessed at Visit 1 (within 4 weeks), Visit 3 (2 weeks), Visit 4 (6 weeks), Visit 5 (3 months), Visit 6 (6 months). The score can range from 0 to 100, with a higher score indicating less severe symptoms.]
• Pelvic Floor Distress Inventory (PFDI) [Time frame: Assessed at Visit 1 (within 4 weeks), Visit 5 (3 months), Visit 6 (6 months), Visit 10 (18 months), Visit 13 (30 months), Visit 15 (42 months), Visit 17 (54 months). The score can range from 0 to 300, with a higher score indicating more severe symptoms.]

Eligibility criteria

I. Inclusion Criteria:

• 2018 FIGO stage IB2 or IIA1 cervical cancer (tumor maximum diameter ≥2 cm and <4 cm)
• Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
• Planned for Type B or C radical hysterectomy
• 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
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Previous history of other invasive malignancies with no evidence of recurrence for at least 5 years
• Signed and approved consent form

II. Exclusion Criteria:

• Histological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
• Tumor size less than 2 cm classified as 2018 FIGO stage IA1, IA2, or IB1 disease
• 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
• Prior pelvic or abdominal radiotherapy
• Prior neoadjuvant chemotherapy before surgery
• Unsuitable for surgery due to severe systemic disease at the investigator's discretion
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

South Korea · 1 center

• Seoul National University College of Medicine — Seoul

Identifiers

NCT: NCT07256977 · SOLUTION2 · 0620202330

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗