LAUNCH 2: Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)
Study Details
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 IB1, IB2, IIA1).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IB1, IB2, IIA1), by a multicenter stratified randomized controlled study, mainly including the following aspects:
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To compare the differences in PFS and OS between patients receiving LRH and ARH.
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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).
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To assess postoperative complications and quality of survival.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 the group of LRH |
Other: Total Laparoscopic or Robotic Radical Hysterectomy
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.
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| Active Comparator: 2 the group of ARH |
Other: Total Abdominal Radical Hysterectomy
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.
|
Outcome Measures
Primary Outcome Measures
- the rate of PFS at 5 years [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
- the rate of OS at 5 years [5 years from surgery]
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
- Analysis of continuous outcomes [1 years from surgery]
Compare these between groups(The continuous outcomes include operative duration, anesthesia time, blood loss during operation, postoperative pain score and postoperative hospital stay.)
- Analysis of binary outcomes [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.)
- Safety analysis [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
Criteria
Inclusion Criteria:
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Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB1,IB2,IIA1).
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Age ≥ 21 years and ≤ 70 years.
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Surgery type B and C (refer to Q-M surgical staging)
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Normal range of liver and kidney function and blood count (specific details below) Hemoglobin > 60g/L Platelets > 70109/L Leukocytes > 3109/L Creatinine < 50mg/dL Transaminase abnormal indicators ≤ 3 Maximum value of transaminases not exceeding 3 times the corresponding normal value.
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No history of other malignancies.
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Non-pregnancy.
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Physical strength classification: Karnofsky score ≥ 60;
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Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up.
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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:
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Those who are contraindicated for various surgeries and cannot undergo surgery.
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Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer.
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Patients with recurrent cervical cancer
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Obstetrics and Gynecology Hospital of Fudan University | Shanghai | Shanghai | China | 200000 |
Sponsors and Collaborators
- Obstetrics & Gynecology Hospital of Fudan University
- 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
- Principal Investigator: Xin Wu, PHD, The Obstetrics and Gynecology Hospital of Fudan University
Study Documents (Full-Text)
More Information
Publications
None provided.- FUOBGY2021-04