NCT04370496Recruiting
Safety of Minimally Invasive Surgery Using Endoscopic Stapler in Early Stage Cervical Cancer Patients (SOLUTION)
Safety Of Laparoscopic or Robotic Radical Hysterectomy Using Endoscopic sTapler for Inhibiting tumOr Spillage of Cervical Neoplasms (SOLUTION): a Phase II Study
Source: ClinicalTrials.gov · Last updated 26 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 19 Apr 2020
- Start date
- 2 Jul 2020
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT04370496
What you commit to
- Study type: Interventional
- Planned participants: 124
- From 2 Jul 2020 to the primary completion date, 31 Dec 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with contraindication of surgery (serious concomitant systemic disorders incompatible with the study to be decided at the discretion of the investigator)
Other illness
- 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 with a history of pelvic or abdominal radiotherapy
- 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
Other
- 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 in pregnancy
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center, Sungkyunkwan University School of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.