Status:
RECRUITING
Safety of Minimally Invasive Surgery Using Endoscopic Stapler in Early Stage Cervical Cancer Patients (SOLUTION)
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Cervical Cancer
Cervical Cancer Stage IB1
Eligibility:
FEMALE
20+ years
Phase:
NA
Brief 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 st...
Detailed Description
Cervical cancer is the 4th most common gynecologic cancer and treatment in early stages consists of surgery, chemotherapy, or radiation therapy. Surgical methods are simple or radical hysterectomy and...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04370496
Start Date
July 2 2020
End Date
December 31 2028
Last Update
June 26 2023
Active Locations (3)
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1
Seoul National University Hospital
Seoul, South Korea, 03080
2
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea
3
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine
Suwon, South Korea