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
Seoul National University Hospital
124 participants
Jul 2, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria13
- 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 Criteria14
- 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
Interventions
Radical hysterectomy by minimally invasive surgery (laparoscopic or robotic) will be done with the help of an endoscopic stapler in cutting and suturing the uterine cervix.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT04370496