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Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2) (LAUNCH 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04934982
Recruitment Status : Recruiting
First Posted : June 22, 2021
Last Update Posted : November 10, 2021
Sponsor:
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
Information provided by (Responsible Party):
Hua Jiang, Obstetrics & Gynecology Hospital of Fudan University

Study Description
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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 IA1 with LVSI, IA2)

Condition or disease Intervention/treatment Phase
Cervical Cancer Other: Total Laparoscopic or Robotic Radical Hysterectomy Other: Total Abdominal Radical Hysterectomy Not Applicable

Detailed Description:

The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IA1 with LVSI, IA2), by a multicenter stratified randomized controlled study, mainly including the following aspects:

  1. To compare the differences in PFS and OS between patients receiving LRH and ARH.
  2. 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).
  3. To assess postoperative complications and quality of survival.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 690 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer (Stage IA1 With LVSI, IA2)
Actual Study Start Date : September 24, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
the group of LRH
 Other: Total Laparoscopic or Robotic Radical Hysterectomy
Stage IA1 with lymphovascular interstitial infiltration and IA2 surgical approach was type B (modified radical hysterectomy plus bilateral pelvic lymph node dissection, i.e., resection of 1~2 cm of the parametrium and 1~2 cm of the vagina) with abdominal para-aortic lymph node dissection if necessary (surgical staging according to FIGO 2018 and surgical staging according to Querleu-Morrow staging).
Active Comparator: 2
the group of ARH
 Other: Total Abdominal Radical Hysterectomy
Stage IA1 with lymphovascular interstitial infiltration and IA2 surgical approach was type B (modified radical hysterectomy plus bilateral pelvic lymph node dissection, i.e., resection of 1~2 cm of the parametrium and 1~2 cm of the vagina) with abdominal para-aortic lymph node dissection if necessary (surgical staging according to FIGO 2018 and surgical staging according to Querleu-Morrow staging).


Outcome Measures
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Primary Outcome Measures :
  1. the rate of PFS at 5 years [ Time Frame: 5 years from surgery ]
    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.


Secondary Outcome Measures :
  1. the rate of OS at 5 years [ Time Frame: 5 years from surgery ]
    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.)


Other Outcome Measures:
  1. Analysis of continuous outcomes [ Time Frame: 1 years from surgery ]
    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.)

  2. Analysis of binary outcomes [ Time Frame: 5 years from surgery ]
    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.)

  3. Safety analysis [ Time Frame: 5 years from surgery ]
    Adverse events (AEs) will be summarised using the number of AEs, the number (%) of participants with AEs by groups.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (IA1 with lymphovascular interstitial invasion, stage IA2).
  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04934982


Contacts
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Contact: Hua Jiang, PHD (021)33189900-6529 jianghua@fudan.edu.cn
Contact: Xin Wu, PHD (021)33189900-6529 wuxin_fc@fudan.edu.cn

Locations
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China
The Obstetrics and Gynecology Hospital of Fudan University Recruiting
Shanghai, China, 20000
Contact: Hua Jiang, PHD         
Contact    (86)13601978182    jianghua@fudan.edu.cn   
Sponsors and Collaborators
Hua Jiang
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
Investigators
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Principal Investigator: Hua Jiang, PHD The Obstetrics and Gynecology Hospital of Fudan University
  Study Documents (Full-Text)

Documents provided by Hua Jiang, Obstetrics & Gynecology Hospital of Fudan University:
Study Protocol and Statistical Analysis Plan  [PDF] December 21, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hua Jiang, Chief Physician, Obstetrics & Gynecology Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT04934982    
Other Study ID Numbers: FUOBGY2021-03
First Posted: June 22, 2021    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hua Jiang, Obstetrics & Gynecology Hospital of Fudan University:
Cervical Cancer
Abdominal Radical Hysterectomy
Laparoscopic Radical Hysterectomy
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases