Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)

NCT04929769 | Recruiting DMC

• 1 other identifier: FUOBGY2021-04
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

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).

Conditions

Cervical Cancer

Keywords

Cervical Cancer; Abdominal Radical Hysterectomy; Laparoscopic Radical Hysterectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years from surgery

Secondary Outcomes (1)

• the rate of OS at 5 years

  5 years from surgery

Other Outcomes (3)

• Analysis of continuous outcomes

  1 years from surgery

• Analysis of binary outcomes

  5 years from surgery

• Safety analysis

  5 years from surgery

Study Arms (2)

1

EXPERIMENTAL

the group of LRH

Other: Total Laparoscopic or Robotic Radical Hysterectomy

2

ACTIVE COMPARATOR

the group of ARH

Other: Total Abdominal Radical Hysterectomy

Interventions

Total Laparoscopic or Robotic Radical Hysterectomy OTHER

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.

1

Total Abdominal Radical Hysterectomy OTHER

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

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB1,IB2,IIA1).
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Obstetrics & Gynecology Hospital of Fudan University: lead
• Children's Hospital of Fudan University: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai Zhongshan Hospital: collaborator
• RenJi Hospital: collaborator
• Taizhou Hospital, Affiliated Cancer Hospital of the University of Chinese Academy of Sciences: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator

Study Sites (1)

The Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (1)

• Wu X, Qiu L, 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, Bai Y, Hou Y, Yan W, Feng H, Yu H, Zhu S, Du Y, Jiang H. A multicenter non-inferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stages IB1, IB2, and IIA1): study protocol of the LAUNCH 2 trial. Trials. 2022 Apr 8;23(1):269. doi: 10.1186/s13063-022-06245-5.

  PMID: 35395868 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Xin Wu, PHD

  The Obstetrics and Gynecology Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Wu, PHD

CONTACT

(021)33189900-6529; wuxin_fc@fudan.edu.cn

Jiang Hua, PHD

CONTACT

(021)33189900-6529; jianghua@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 18, 2021
• Study Start: May 7, 2021
• Primary Completion: September 7, 2024
• Study Completion (Estimated): September 7, 2026
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)