Minimally invasive surgery for early stage cervical cancer patients
Safety Of Laparoscopic or Robotic Radical Hysterectomy Using Endoscopic sTapler for Inhibiting tumOr Spillage of Cervical Neoplasms (SOLUTION): a Phase II Study
This study tests whether a new minimally invasive surgery for early stage cervical cancer is as safe and effective as traditional open surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Seoul and 2 other locations) |
| Trial ID | NCT04370496 on ClinicalTrials.gov |
What this trial studies
The SOLUTION trial investigates the safety and efficacy of performing radical hysterectomy using minimally invasive surgery with an endoscopic stapler in patients diagnosed with cervical cancer stage IB1. This approach aims to demonstrate that minimally invasive techniques are as safe as traditional open surgery. The study addresses concerns raised by previous trials regarding the potential risks associated with minimally invasive procedures, particularly the exposure of tumor cells to the peritoneal cavity. By employing specific surgical techniques, the trial seeks to minimize these risks and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 20 years or older with histologically confirmed cervical cancer stage IB1.
Not a fit: Patients with tumor sizes greater than 4 cm or those with histological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer surgical option for patients with early-stage cervical cancer, potentially leading to better recovery and outcomes.
How similar studies have performed: Previous studies have raised concerns about the safety of minimally invasive surgery for cervical cancer, making this approach novel and potentially groundbreaking.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul and 2 other locations
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Samsung Medical Center, Sungkyunkwan University School of Medicine — Seoul, South Korea (Recruiting)
- Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine — Suwon, South Korea (Recruiting)
Study contacts
- Principal investigator: Hee Seung Kim, M.D. Ph.D. — Seoul National University Hospital
- Study coordinator: Soo Jin Park, M.D.
- Email: soojin.mdpark@gmail.com
- Phone: +82-02-2072-0897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.