Safety of Minimally Invasive Surgery Using Endoscopic Stapler in Early Stage Cervical Cancer Patients (SOLUTION)

NCT04370496RecruitingNAINTERVENTIONAL

Summary

The SOLUTION trial aims to show the efficacy and safety of performing radical hysterectomy by minimally invasive surgery using an endoscopic stapler in patients with cervical cancer stage IB1 (FIGO staging 2009) and thus to prove that minimally invasive surgery is non-inferior to open surgery.

Key Facts

Lead Sponsor

Seoul National University Hospital

Enrollment

124

Start Date

2020-07-02

Completion Date

2028-12-31

Study Type

INTERVENTIONAL

Official Title

Safety Of Laparoscopic or Robotic Radical Hysterectomy Using Endoscopic sTapler for Inhibiting tumOr Spillage of Cervical Neoplasms (SOLUTION): a Phase II Study

Interventions

Minimally invasive surgery using endoscopic stapler

Conditions

Cervical CancerCervical Cancer Stage IB1Minimally Invasive Surgery

Eligibility

Age Range

20 Years+

Sex

FEMALE

Inclusion Criteria:

* Females, aged 20 years or older
* Histologically confirmed primary squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix
* Patients with FIGO stage IB1 (FIGO staging 2009)

  : stromal invasion\>5 mm or 7 mm \<lesion size ≤4 cm
* Patients undergoing either type B or C hysterectomy (Querleu-Morrow classification)
* Patients with normal bone marrow, renal and hepatic function

  * WBC \> 3.0x10\^9 cells/L
  * Platelets \> 100x10\^9 cells/L
  * Serum creatinine ≤1.5 mg/dL
  * Serum total bilirubin \<1.5 x normal range and AST/SGOT or ALT/SGPT \<3 x normal range
* ECOG performance status 0 or 1
* Synchronous cancer with no evidence of recurrence during the past 5 years
* Informed consent of patient

Exclusion Criteria:

* Any histological type other than squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix
* Tumor size greater than 4 cm
* Patients with FIGO less than stage IA2 or greater than IB2 (FIGO staging 2009)

  * stromal invasion ≤5 mm and lesion size ≤7 mm (less than IA2)
  * or lesion size\> 4 cm (greater than IB2)
* Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes greater than 2 cm, or histologically positive lymph nodes
* Patients in pregnancy
* Patients with a history of pelvic or abdominal radiotherapy
* Patients with contraindication of surgery (serious concomitant systemic disorders incompatible with the study to be decided at the discretion of the investigator)
* Patients who agree to intra-operative lymphatic mapping (IOLM) must not have:

  * Known allergies to triphenylmethane compounds
  * History of retroperitoneal surgery.
  * History of pelvic irradiation.
  * Cold knife or LEEP cone biopsy within 4 weeks of enrollment

Outcome Measures

Primary Outcomes

4.5 year disease-free survival [DFS] rate

Probability of no recurrence from the day of surgery until post-operative 4.5 years

Time frame: Examined at post-operative 4.5 years

Secondary Outcomes

4.5 year overall survival [OS] rate

Rate of survival from the day of surgery until post-operative 4.5 years

Time frame: Examined at post-operative 4.5 years

Pattern of recurrence sites

Anatomical site of recurrent cancer according to imaging modalities

Time frame: Examined every 3 months during post-operative 1 year, every 2 months during post-operative 2 years, and every 6 months during post-operative 4.5 years

Morbidity

Intra-operative and post-operative complications occurring in less than post-operative 4 weeks and between post-operative 4 and 6 weeks. Other morbidity include estimated blood loss during surgery, post-operative pain and amount of analgesic consumption

Time frame: Examined during operation and post-operative 4 and 6 weeks.

Locations

Seoul National University Hospital, Seoul, South Korea

Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine, Suwon, South Korea

Linked Papers

2022-03-26

Safety and efficacy study of laparoscopic or robotic radical surgery using an endoscopic stapler for inhibiting tumour spillage of cervical malignant neoplasms evaluating survival (SOLUTION): a multi-centre, open-label, single-arm, phase II trial protocol

Abstract Background The Laparoscopic Approach to Cervical Cancer trial and Surveillance, Epidemiology, and End Results program database study demonstrated that minimally invasive radical hysterectomy was inferior to abdominal radical hysterectomy in terms of disease recurrence and survival. Among risk factors related to poor prognosis after minimally invasive surgery (MIS), tumour spillage during intracorporeal colpotomy became a significant issue. Thus, we designed this trial to evaluate the efficacy and safety of minimally invasive radical hysterectomy using an endoscopic stapler for early-stage cervical cancer. Methods This trial is a prospective, multi-centre, open-label, single-arm, non-inferiority phase II study. The nine organisations will participate in this trial after the approval of the institutional review board. Major eligibility criteria include women aged 20 years or older with cervical cancer stage IB1 squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma according to the revised 2009 FIGO staging system who will undergo type B2 or C hysterectomy by MIS. The primary endpoint is the 4.5-year disease-free survival (DFS) rate between abdominal radical hysterectomy and MIS using an endoscopic stapler. For calculating the sample size, we hypothesised that the 4.5-year DFS rate after MIS using an endoscopic stapler is assumed to be the same after abdominal radical hysterectomy at 90.9%, and the non-inferiority margin was 7.2%. When we consider a three-year accrual and 4.5-year follow-up, at least 13 events must happen, requiring a total of 111 patients assuming a statistical power of 80% and the one-tailed test of 5% significance. A total of 124 patients is needed, considering a drop-out rate of 10%. Discussion We expect intracorporeal colpotomy using an endoscopic stapler may prevent tumour spillage during MIS for stage IB1 cervical cancer, showing a comparable prognosis with abdominal radical surgery. Trial registration ClinicalTrials.gov; NCT04370496; registration date, May 2020.

2021-09-01

Solution to prevent tumor spillage in minimally invasive radical hysterectomy using the endoscopic stapler for treating early-stage cervical cancer: Surgical technique with video

Gynecologic oncologists had originally preferred minimally invasive surgery (MIS) over laparotomic surgery for patients with early-stage cervical cancer until the Laparoscopic Approach to Cervical Cancer (LACC) trial reported a worse prognosis and more loco-regional recurrence in patients treated with MIS. Although some controversy remains, experts suggested that tumor cell spillage and aggravation may have been caused by intra-corporeal colpotomy, usage of uterine elevators, maintenance of Trendelenburg position, and tumor irritation by capnoperitoneum during surgery. Thus, we introduce a surgical procedure with some steps added to the conventional MIS radical hysterectomy for preventing tumor spillage during the surgery, which is currently being evaluated in terms of safety and efficacy through a prospective, multicenter, single-arm, phase II study, entitled "Safety of laparoscopic or robotic radical surgery using endoscopic stapler for inhibiting tumor spillage of cervical neoplasms (SOLUTION trial: NCT04370496)".

Linked Investigators

Hee Seung Kim