Status Approved
First Submitted Date
2020/04/28
Registered Date
2020/05/21
Last Updated Date
2020/05/20
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005045 |
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Unique Protocol ID | H-2002-101-1103 |
Public/Brief Title | Safety Of Laparoscopic or robotic radical hysterectomy Using endoscopic sTapler for Inhibiting tumOr spillage of cervical Neoplasms (SOLUTION): a phase II study |
Scientific Title | Safety Of Laparoscopic or robotic radical hysterectomy Using endoscopic sTapler for Inhibiting tumOr spillage of cervical Neoplasms (SOLUTION): a phase II study |
Acronym | SOLUTION |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | Yes |
Name of Registry / Registration Number | ClinicalTrials.gov-NCT04370496 |
Healthcare Benefit Approval Status | Submitted pending |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | H-2002-101-1103 |
Approval Date | 2020-04-14 |
Institutional Review Board Name | Seoul National University College of Medicine / Seoul National University Hospital Institutional Review Board |
Institutional Review Board Address | 101, Daehak-ro, Jongno-gu, Seoul |
Institutional Review Board Telephone | 02-2072-0694 |
Data Monitoring Committee |
Yes
SOLUTION Data and Safety Monitoring Board |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Hee Seung Kim |
Title | Associate Professor |
Telephone | +82-2-2072-2388 |
Affiliation | Seoul National University Hospital |
Address | 101, Daehak-ro, Jongno-gu, Seoul, Republic of Korea |
Contact Person for Public Queries | |
Name | Soo Jin Park |
Title | Fellow |
Telephone | +82-2-2072-0897 |
Affiliation | Seoul National University Hospital |
Address | 101, Daehak-ro, Jongno-gu, Seoul, Republic of Korea |
Contact Person for Updating Information | |
Name | Soo Jin Park |
Title | Fellow |
Telephone | +82-2-2072-0897 |
Affiliation | Seoul National University Hospital |
Address | 101, Daehak-ro, Jongno-gu, Seoul, Republic of Korea |
4. Status
Study Site | Multi-center Number of center : 10 | |
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Overall Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-05-21 Anticipated | |
Target Number of Participant | 124 | |
Primary Completion Date | 2028-12-31 , Anticipated | |
Study Completion Date | 2028-12-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Seoul National University Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-05-21 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | Ajou University Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-05-21 , | |
Recruitment Status by Participating Study Site 3 | ||
Name of Study | The Catholic University of Korea, Seoul St. Mary's Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-05-21 , | |
Recruitment Status by Participating Study Site 4 | ||
Name of Study | Konkuk University Medical Center | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-05-21 , | |
Recruitment Status by Participating Study Site 5 | ||
Name of Study | National Cancer Center | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-05-21 , | |
Recruitment Status by Participating Study Site 6 | ||
Name of Study | Samsung Medical Center | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-05-21 , | |
Recruitment Status by Participating Study Site 7 | ||
Name of Study | Yonsei University, Wonju Severance Christian Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-05-21 , | |
Recruitment Status by Participating Study Site 8 | ||
Name of Study | Kangbuk Samsung Medical Center | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-05-21 , | |
Recruitment Status by Participating Study Site 9 | ||
Name of Study | Yonsei University Health System, Severance Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-05-21 , | |
Recruitment Status by Participating Study Site 10 | ||
Name of Study | Seoul Metropolitan Government Seoul National University Boramae Medical Center | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-05-21 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Johnson & Johnson Medical Korea |
Organization Type | Pharmaceutical Company |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Seoul National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | 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: 1) 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. 2) Insertions of uterine manipulators into the endometrial cavity is commonly done, which can cause tumor cells to travel to both salpinges. 3) Tumor cells can be exposed to the peritoneal cavity when the cervix is exposed during intracorporeal colpotomy. 4) 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. 1) The application of a vaginal tube instead of a uterine manipulator to prevent tumor cells from traveling to the salpinges. 2) The ligation of both salpinges prior to insertion of a vaginal tube to block the travel of tumor cells. 3) The performance of extracorporeal colpotomy instead of intracorporeal colpotomy to prevent the exposure of tumor cells inside the peritoneal cavity during colpotomy after radical hysterectomy. Extracorporeal colpotomy is difficult to perform especially in menopausal patients with atrophic vaginitis or patients with no sexual experience. Thus, an alternative method for intracorporeal colpotomy 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. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Phase2 |
Intervention Model | Single Group |
Blinding/Masking | Open |
Allocation | Not Applicable |
Intervention Type | /Procedure/Surgery |
Intervention 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. |
Number of Arms | 1 |
Arm 1 |
Arm Label SOLUTION group |
Target Number of Participant 124 |
|
Arm Type Experimental |
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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. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (C00-D48)Neoplasms (C53.9)Malignant neoplasm of cervix uteri, unspecified cervical cancer |
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Rare Disease | No |
Inclusion Criteria |
Gender Female |
Age 20Year~No Limit |
|
Description ※ 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 |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | 4.5 year disease-free survival [DFS] rate |
|
Timepoint | Every 3 months in post-op 1 year, every 4 months in post-op 2 years, every 6 months in post-op 3.5-4 years |
|
Secondary Outcome(s) 1 | ||
Outcome | 4.5 year overall survival [OS] rate |
|
Timepoint | Every 3 months in post-op 1 year, every 4 months in post-op 2 years, every 6 months in post-op 3.5-4 years |
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Secondary Outcome(s) 2 | ||
Outcome | Pattern of recurrence sites |
|
Timepoint | Every 3 months in post-op 1 year, every 4 months in post-op 2 years, every 6 months in post-op 3.5-4 years |
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Secondary Outcome(s) 3 | ||
Outcome | Morbidity |
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Timepoint | Every 3 months in post-op 1 year, every 4 months in post-op 2 years, every 6 months in post-op 3.5-4 years |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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