Cervical Cancer Clinical Trial
— SOLUTIONOfficial title:
Safety Of Laparoscopic or Robotic Radical Hysterectomy Using Endoscopic sTapler for Inhibiting tumOr Spillage of Cervical Neoplasms (SOLUTION): a Phase II Study
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 | Recruiting |
Enrollment | 124 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center, Sungkyunkwan University School of Medicine | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine | Suwon |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Johnson & Johnson |
Korea, Republic of,
Cohen 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. — View Citation
Kim 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-II — View Citation
Kohler 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 — View Citation
Nam 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 A — View Citation
Park 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. — View Citation
Ramirez 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 Hysterec — View Citation
Wood 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 4.5 year disease-free survival [DFS] rate | Probability of no recurrence from the day of surgery until post-operative 4.5 years | Examined at post-operative 4.5 years | |
Secondary | 4.5 year overall survival [OS] rate | Rate of survival from the day of surgery until post-operative 4.5 years | Examined at post-operative 4.5 years | |
Secondary | Pattern of recurrence sites | Anatomical site of recurrent cancer according to imaging modalities | Examined every 3 months during post-operative 1 year, every 2 months during post-operative 2 years, and every 6 months during post-operative 4.5 years | |
Secondary | Morbidity | Intra-operative and post-operative complications occurring in less than post-operative 4 weeks and between post-operative 4 and 6 weeks. Other morbidity include estimated blood loss during surgery, post-operative pain and amount of analgesic consumption | Examined during operation and post-operative 4 and 6 weeks. |
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