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Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2) (LAUNCH 3)

Primary Purpose

Cervical Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Total Laparoscopic or Robotic Radical Hysterectomy
Total Abdominal Radical Hysterectomy
Sponsored by
Obstetrics & Gynecology Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Cervical Cancer, Abdominal Radical Hysterectomy, Laparoscopic Radical Hysterectomy

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB3,IIA2).
  2. Age ≥ 21 years and ≤ 70 years.
  3. Surgery type B and C (refer to Q-M surgical staging)
  4. Normal range of liver and kidney function and blood count (specific details below) Hemoglobin > 60g/L Platelets > 70*109/L Leukocytes > 3*109/L Creatinine < 50mg/dL Transaminase abnormal indicators ≤ 3 Maximum value of transaminases not exceeding 3 times the corresponding normal value.
  5. No history of other malignancies.
  6. Non-pregnancy.
  7. Physical strength classification: Karnofsky score ≥ 60;
  8. Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up.
  9. No psychiatric disorders and other serious immune system disorders (e.g. lupus erythematosus, myasthenia gravis, HIV infection, etc.) (Note: Maximum diameter measurement of cervical lesions is based on PET-CT, or CT, or MRI)

Exclusion Criteria:

  1. Those who are contraindicated for various surgeries and cannot undergo surgery.
  2. Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer.
  3. Patients with recurrent cervical cancer
  4. Patients with CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter >2cm after further improvement of preoperative examination.

Sites / Locations

  • The Obstetrics and Gynecology Hospital of Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

the group of LRH

the group of ARH

Outcomes

Primary Outcome Measures

the rate of OS at 5 years
Compare between groups(Cox proportional hazards model will be used to estimate the hazard ratio and 95% CI for the effect of treatment on the 5-year OS rate.)

Secondary Outcome Measures

the rate of PFS at 5 years
The curves of PFS at 5 years will be estimated using the Kaplan-Meier method. The logrank test will be used to test the above hypothesis, the 5-year PFS rate difference and its 95% confidence interval (CI) for the comparison between the two groups will be estimated.

Full Information

First Posted
June 9, 2021
Last Updated
November 2, 2021
Sponsor
Obstetrics & Gynecology Hospital of Fudan University
Collaborators
Children's Hospital of Fudan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Zhongshan Hospital, RenJi Hospital, Taizhou Hospital, Affiliated Cancer Hospital of the University of Chinese Academy of Sciences, First Affiliated Hospital of Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04939831
Brief Title
Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)
Acronym
LAUNCH 3
Official Title
A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Obstetrics & Gynecology Hospital of Fudan University
Collaborators
Children's Hospital of Fudan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Zhongshan Hospital, RenJi Hospital, Taizhou Hospital, Affiliated Cancer Hospital of the University of Chinese Academy of Sciences, First Affiliated Hospital of Wenzhou Medical University

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 purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IB3, IIA2).
Detailed Description
The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IB3, IIA2), by a multicenter stratified randomized controlled study, mainly including the following aspects: To compare the differences in PFS and OS between patients receiving LRH and ARH. To investigate whether PFS and OS in LRH can be improved by more rigorous specification of surgical details (including tumor-free principles and standard surgical scopes). To assess postoperative complications and quality of survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Cervical Cancer, Abdominal Radical Hysterectomy, Laparoscopic Radical Hysterectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
the group of LRH
Arm Title
2
Arm Type
Active Comparator
Arm Description
the group of ARH
Intervention Type
Other
Intervention Name(s)
Total Laparoscopic or Robotic Radical Hysterectomy
Intervention Description
Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.
Intervention Type
Other
Intervention Name(s)
Total Abdominal Radical Hysterectomy
Intervention Description
Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.
Primary Outcome Measure Information:
Title
the rate of OS at 5 years
Description
Compare between groups(Cox proportional hazards model will be used to estimate the hazard ratio and 95% CI for the effect of treatment on the 5-year OS rate.)
Time Frame
5 years from surgery
Secondary Outcome Measure Information:
Title
the rate of PFS at 5 years
Description
The curves of PFS at 5 years will be estimated using the Kaplan-Meier method. The logrank test will be used to test the above hypothesis, the 5-year PFS rate difference and its 95% confidence interval (CI) for the comparison between the two groups will be estimated.
Time Frame
5 years from surgery
Other Pre-specified Outcome Measures:
Title
Analysis of continuous outcomes
Description
Compare these between groups(The continuous outcomes include operative duration(min), anesthesia time(min), blood loss during operation(ml), postoperative pain score and postoperative hospital stay(day). The outcomes with normal distribution will be summarised using mean and standard deviation (SD), while the outcomes with non-normal distribution will be summarised using median and interquartile. The differences in the outcomes and 95% CIs will be analysed by generalised linear model (GLM) with treatment as fixed effect and with normal distribution and identity link function.)
Time Frame
1 years from surgery
Title
Analysis of binary outcomes
Description
Compare these between groups(The intraoperative complications, postoperative complications, one-month and one-year postoperative quality of life and sexual life will be treated as binary outcomes and will be summarised by number (%) of participants with the event. The differences in the outcomes and 95% CIs will be analysed by GLM with treatment as fixed effect and with binomial distribution and identity link function.)
Time Frame
5 years from surgery
Title
Safety analysis
Description
Adverse events (AEs) will be summarised using the number of AEs, the number (%) of participants with AEs by groups.
Time Frame
5 years from surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB3,IIA2). Age ≥ 21 years and ≤ 70 years. Surgery type B and C (refer to Q-M surgical staging) Normal range of liver and kidney function and blood count (specific details below) Hemoglobin > 60g/L Platelets > 70*109/L Leukocytes > 3*109/L Creatinine < 50mg/dL Transaminase abnormal indicators ≤ 3 Maximum value of transaminases not exceeding 3 times the corresponding normal value. No history of other malignancies. Non-pregnancy. Physical strength classification: Karnofsky score ≥ 60; Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up. No psychiatric disorders and other serious immune system disorders (e.g. lupus erythematosus, myasthenia gravis, HIV infection, etc.) (Note: Maximum diameter measurement of cervical lesions is based on PET-CT, or CT, or MRI) Exclusion Criteria: Those who are contraindicated for various surgeries and cannot undergo surgery. Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer. Patients with recurrent cervical cancer Patients with CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter >2cm after further improvement of preoperative examination.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Jiang, PHD
Phone
(021)33189900-6529
Email
jianghua@fudan.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Wu, PHD
Phone
(021)33189900-6529
Email
wuxin_fc@fudan.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hua Jiang, PHD
Organizational Affiliation
The Obstetrics and Gynecology Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Obstetrics and Gynecology Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Jiang, PHD
Phone
(86)13601978182
Email
jianghua@fudan.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)

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