Actively Recruiting
Safety of Minimally Invasive Surgery Using Endoscopic Stapler in Early Stage Cervical Cancer Patients (SOLUTION)
Led by Seoul National University Hospital · Updated on 2023-06-26
124
Participants Needed
3
Research Sites
443 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Hospital
Lead Sponsor
J
Johnson & Johnson
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety of Minimally Invasive Surgery Using Endoscopic Stapler in Early Stage Cervical Cancer Patients (SOLUTION)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, aged 20 years or older
- Histologically confirmed primary squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix
- Cervical cancer stage IB1 (FIGO staging 2009) with stromal invasion greater than 5 mm or lesion size 4 cm or smaller
- Undergoing type B or C hysterectomy (Querleu-Morrow classification)
- Normal bone marrow, renal, and liver function (WBC > 3.0x10^9 cells/L; Platelets > 100x10^9 cells/L; Serum creatinine ≤ 1.5 mg/dL; Total bilirubin < 1.5 x normal; AST/SGOT or ALT/SGPT < 3 x normal)
- ECOG performance status 0 or 1
- No evidence of cancer recurrence from synchronous cancers in the past 5 years
- Patient provides informed consent
You will not qualify if you...
- Histological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix
- Tumor size greater than 4 cm
- Cervical cancer stage less than IA2 or greater than IB2 (FIGO staging 2009)
- Evidence of metastatic disease on imaging, enlarged pelvic or aortic lymph nodes greater than 2 cm, or positive lymph nodes by biopsy
- Pregnancy
- History of pelvic or abdominal radiotherapy
- Any medical condition that makes surgery unsafe as determined by the investigator
- Allergy to triphenylmethane compounds (if agreeing to intra-operative lymphatic mapping)
- History of retroperitoneal surgery (if agreeing to intra-operative lymphatic mapping)
- History of pelvic irradiation (if agreeing to intra-operative lymphatic mapping)
- Cold knife or LEEP cone biopsy within 4 weeks before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
2
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea
Actively Recruiting
3
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine
Suwon, South Korea
Actively Recruiting
Research Team
S
Soo Jin Park, M.D.
CONTACT
J
Jaehee Mun, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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