Clinical trial · Interventional
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
NCT04370496CI-TRIAL-00067504SOLUTIONrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer Stage IB1 | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Minimally Invasive Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Minimally invasive surgery using endoscopic stapler | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SOLUTION group
- description
- Patients enrolled in this clinical trial will undergo radical hysterectomy through minimally invasive surgery using an endoscopic stapler which both cuts and simultaneously sutures the open vaginal stump.
- interventionNames
- Procedure: Minimally invasive surgery using endoscopic stapler
Primary outcomes (1)
- measure
- 4.5 year disease-free survival [DFS] rate
- timeFrame
- Examined at post-operative 4.5 years
- description
- Probability of no recurrence from the day of surgery until post-operative 4.5 years
Secondary outcomes (3)
- measure
- 4.5 year overall survival [OS] rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (9)
- BACKGROUNDCohen PA, Jhingran A, Oaknin A, Denny L. Cervical cancer. Lancet. 2019 Jan 12;393(10167):169-182. doi: 10.1016/S0140-6736(18)32470-X. PMID 30638582
- BACKGROUNDWood DE. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Lung Cancer Screening. Thorac Surg Clin. 2015 May;25(2):185-97. doi: 10.1016/j.thorsurg.2014.12.003. Epub 2015 Jan 28. PMID 25901562
- RESULTNam JH, Park JY, Kim DY, Kim JH, Kim YM, Kim YT. Laparoscopic versus open radical hysterectomy in early-stage cervical cancer: long-term survival outcomes in a matched cohort study. Ann Oncol. 2012 Apr;23(4):903-11. doi: 10.1093/annonc/mdr360. Epub 2011 Aug 12. PMID 21841155
- RESULTPark JY, Kim DY, Kim JH, Kim YM, Kim YT, Nam JH. Laparoscopic versus open radical hysterectomy in patients with stage IB2 and IIA2 cervical cancer. J Surg Oncol. 2013 Jul;108(1):63-9. doi: 10.1002/jso.23347. Epub 2013 Jun 5. PMID 23737035
- RESULTRamirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, Buda A, Yan X, Shuzhong Y, Chetty N, Isla D, Tamura M, Zhu T, Robledo KP, Gebski V, Asher R, Behan V, Nicklin JL, Coleman RL, Obermair A. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. N Engl J Med. 2018 Nov 15;379(20):1895-1904. doi: 10.1056/NEJMoa1806395. Epub 2018 Oct 31. PMID 30380365
- RESULTKohler C, Hertel H, Herrmann J, Marnitz S, Mallmann P, Favero G, Plaikner A, Martus P, Gajda M, Schneider A. Laparoscopic radical hysterectomy with transvaginal closure of vaginal cuff - a multicenter analysis. Int J Gynecol Cancer. 2019 Jun;29(5):845-850. doi: 10.1136/ijgc-2019-000388. PMID 31155516
- RESULTKim SI, Cho JH, Seol A, Kim YI, Lee M, Kim HS, Chung HH, Kim JW, Park NH, Song YS. Comparison of survival outcomes between minimally invasive surgery and conventional open surgery for radical hysterectomy as primary treatment in patients with stage IB1-IIA2 cervical cancer. Gynecol Oncol. 2019 Apr;153(1):3-12. doi: 10.1016/j.ygyno.2019.01.008. Epub 2019 Jan 12.