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Safety of Minimally Invasive Surgery Using Endoscopic Stapler in Early Stage Cervical Cancer Patients (SOLUTION) (SOLUTION)

Primary Purpose

Cervical Cancer, Cervical Cancer Stage IB1, Minimally Invasive Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Minimally invasive surgery using endoscopic stapler
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Cervical cancer, Cervical Cancer Stage IB1, Minimally invasive surgery

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting
  • Samsung Medical Center, Sungkyunkwan University School of MedicineRecruiting
  • Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SOLUTION group

Arm 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.

Outcomes

Primary Outcome Measures

4.5 year disease-free survival [DFS] rate
Probability of no recurrence from the day of surgery until post-operative 4.5 years

Secondary Outcome Measures

4.5 year overall survival [OS] rate
Rate of survival from the day of surgery until post-operative 4.5 years
Pattern of recurrence sites
Anatomical site of recurrent cancer according to imaging modalities
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

Full Information

First Posted
April 19, 2020
Last Updated
June 23, 2023
Sponsor
Seoul National University Hospital
Collaborators
Johnson & Johnson
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1. Study Identification

Unique Protocol Identification Number
NCT04370496
Brief Title
Safety of Minimally Invasive Surgery Using Endoscopic Stapler in Early Stage Cervical Cancer Patients (SOLUTION)
Acronym
SOLUTION
Official Title
Safety Of Laparoscopic or Robotic Radical Hysterectomy Using Endoscopic sTapler for Inhibiting tumOr Spillage of Cervical Neoplasms (SOLUTION): a Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2020 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Johnson & Johnson

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 staging 2009) and thus to prove that minimally invasive surgery is non-inferior to open surgery.
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 pelvic and para-aortic lymph node dissection either done in an open manner or minimally invasive surgery (robotic or laparoscopic). However, a phase III cinical trial in 2018 comparing the safety and efficacy between minimally invasive surgery and open surgery in performing radical hysterectomy, 'Laparoscopic Approach to Cervical Cancer' (LACC), showed that open surgery is safer than minimally invasive surgery. Possible causes of such results are as follows: Carbon dioxide is supplied during laparoscopic operations to maintain capnoperitoneum, which can cause the implantation and proliferation of tumor cells exposed to the peritoneal cavity. Insertions of uterine manipulators into the endometrial cavity is commonly done, which can cause tumor cells to travel to both salpinges. Tumor cells can be exposed to the peritoneal cavity when the cervix is exposed during intracorporeal colpotomy. Tumor cells exposed to the peritoneal cavity can travel upwards when the patient's position is maintained in the Trendelenburg position during minimally invasive operations, leading to distant metastasis. Based on the above-mentioned hypothesis, the following methods could be applied to minimize the exposure of tumor cells to the peritoneal cavity. The application of a vaginal tube instead of a uterine manipulator to prevent tumor cells from traveling to the salpinges. The ligation of both salpinges prior to insertion of a vaginal tube to block the travel of tumor cells. The performance of extracorporeal colpotomy instead to prevent the exposure of tumor cells inside the peritoneal cavity. Although it would be favorable to perform all the forementioned methods, extracorporeal colpotomy is difficult to perform especially in menopausal patients with atrophic vaginitis or patients with no sexual experience. Thus, an alternative method is to use an endoscopic stapler which can simultaneously cut and suture the cervix into a vaginal stump, which can prevent tumor cells from being exposed to the peritoneal cavity. In conclusion, this clinical 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Cervical Cancer Stage IB1, Minimally Invasive Surgery
Keywords
Cervical cancer, Cervical Cancer Stage IB1, Minimally invasive surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients enrolled in this clinical trial will undergo surgery for early stage cervical cancer. They will receive either laparoscopic or robotic radical hysterectomy using an endoscopic stapler. The efficacy and safety of this surgical technique will be compared to that of open radical hysterectomy studied in previous trials.
Masking
None (Open Label)
Masking Description
All 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.
Allocation
N/A
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SOLUTION group
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive surgery using endoscopic stapler
Intervention Description
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.
Primary Outcome Measure Information:
Title
4.5 year disease-free survival [DFS] rate
Description
Probability of no recurrence from the day of surgery until post-operative 4.5 years
Time Frame
Examined at post-operative 4.5 years
Secondary Outcome Measure Information:
Title
4.5 year overall survival [OS] rate
Description
Rate of survival from the day of surgery until post-operative 4.5 years
Time Frame
Examined at post-operative 4.5 years
Title
Pattern of recurrence sites
Description
Anatomical site of recurrent cancer according to imaging modalities
Time Frame
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
Title
Morbidity
Description
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
Time Frame
Examined during operation and post-operative 4 and 6 weeks.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Eligible patients must be diagnosed with cervical cancer, limiting eligibility to only females.
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soo Jin Park, M.D.
Phone
+82-02-2072-0897
Email
soojin.mdpark@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jaehee Mun, M.D.
Phone
+82-02-2072-2388
Email
jhee1315@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Seung Kim, M.D. Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo jin Park, MD
Phone
82-2-2072-0897
Email
soojin.mdpark@gmail.com
First Name & Middle Initial & Last Name & Degree
Maria Lee, MD
First Name & Middle Initial & Last Name & Degree
Hee Seung Kim, MD
Facility Name
Samsung Medical Center, Sungkyunkwan University School of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoo Young Lee, MD
First Name & Middle Initial & Last Name & Degree
Chel Hun Choi, MD
Facility Name
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine
City
Suwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Wook Kong, MD
First Name & Middle Initial & Last Name & Degree
Suk Joon Chang, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The plan whether to share IPD will be decided once enrollment of the clinical trial starts.
Citations:
PubMed Identifier
30638582
Citation
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.
Results Reference
background
PubMed Identifier
25901562
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.
Results Reference
background
PubMed Identifier
21841155
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 Aug 12.
Results Reference
result
PubMed Identifier
23737035
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.
Results Reference
result
PubMed Identifier
30380365
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 Hysterectomy for Cervical Cancer. N Engl J Med. 2018 Nov 15;379(20):1895-1904. doi: 10.1056/NEJMoa1806395. Epub 2018 Oct 31.
Results Reference
result
PubMed Identifier
31155516
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. doi: 10.1136/ijgc-2019-000388.
Results Reference
result
PubMed Identifier
30642625
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-IIA2 cervical cancer. Gynecol Oncol. 2019 Apr;153(1):3-12. doi: 10.1016/j.ygyno.2019.01.008. Epub 2019 Jan 12.
Results Reference
result
PubMed Identifier
35346103
Citation
Park SJ, Kong TW, Kim T, Lee M, Choi CH, Shim SH, Yim GW, Lee S, Lee EJ, Lim MC, Chang SJ, Lee SJ, Lee SH, Song T, Lee YY, Kim HS, Nam EJ. Safety and efficacy study of laparoscopic or robotic radical surgery using an endoscopic stapler for inhibiting tumour spillage of cervical malignant neoplasms evaluating survival (SOLUTION): a multi-centre, open-label, single-arm, phase II trial protocol. BMC Cancer. 2022 Mar 26;22(1):331. doi: 10.1186/s12885-022-09429-z.
Results Reference
derived
PubMed Identifier
34481135
Citation
Mun J, Park SJ, Yim GW, Chang SJ, Kim H; Trial Monitoring Committee of SOLUTION trial. Solution to prevent tumor spillage in minimally invasive radical hysterectomy using the endoscopic stapler for treating early-stage cervical cancer: Surgical technique with video. J Gynecol Obstet Hum Reprod. 2021 Dec;50(10):102211. doi: 10.1016/j.jogoh.2021.102211. Epub 2021 Sep 1.
Results Reference
derived

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Safety of Minimally Invasive Surgery Using Endoscopic Stapler in Early Stage Cervical Cancer Patients (SOLUTION)

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