Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)
NCT ID: NCT04939831
Last Updated: 2021-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1104 participants
INTERVENTIONAL
2021-05-12
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
the group of LRH
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.
2
the group of ARH
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
70 Years
FEMALE
No
Sponsors
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Children's Hospital of Fudan University
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Shanghai Zhongshan Hospital
OTHER
RenJi Hospital
OTHER
Taizhou Hospital, Affiliated Cancer Hospital of the University of Chinese Academy of Sciences
UNKNOWN
First Affiliated Hospital of Wenzhou Medical University
OTHER
Obstetrics & Gynecology Hospital of Fudan University
OTHER
Responsible Party
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Principal Investigators
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Hua Jiang, PHD
Role: PRINCIPAL_INVESTIGATOR
The Obstetrics and Gynecology Hospital of Fudan University
Locations
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The Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Hua Jiang, PHD
Role: primary
References
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Wu X, Yu H, Bai Y, Hou Y, Lou W, Wang X, Zhu T, Zhang Y, Hu W, Xue X, Zhu Z, Xiang L, Li J, Fang X, Gao S, Feng H, Diao W, Zhang H, Du M, Yan W, Qiu L, Feng H, Zhu S, Du Y, Jiang H. A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IB3 and IIA2): study protocol of the LAUNCH 3 trial. Trials. 2023 Aug 18;24(1):542. doi: 10.1186/s13063-023-07573-w.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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FUOBGY2021-05
Identifier Type: -
Identifier Source: org_study_id