Selective Pelvic Lymphadenectomy for IB-IIA Cervical Cancer

NCT03295526 | Unknown Phase 2

• 1 other identifier: STCSM2016-6-17-1.1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Test name: Study on selective pelvic lymphadenectomy for IB - IIA cervical cancer Researcher: Wu Xiaohua Research Center: Fudan University Shanghai Cancer Center The trial is expected to last for 3 years Test objectives： The primary goal：The overall therapeutic effect of patients with selective lymphadenectomy was not inferior to patients with systemic pelvic lymphadenectomy. Secondary goal: Selective lymphadenectomy can reduce the incidence and severity of postoperative lower limb lymphedema. The study was designed for prospective, randomized, controlled clinical trials. The number of subjects: 200 cases. Research groupings Selective pelvic lymphadenectomy group and The control group was treated with systematic pelvic lymph node dissection group. Follow-up time: 3 years Sample size: 200 cases End of the trial: Primary end-poin:t three-year survival (overall survival, progression-free survival) Secondary end point: lower limb lymph node lymphedema

Conditions

Cervical Cancer

Keywords

Cervical Cancer, Lymph nodes debulking surgery

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  The period(months) from randomization to death for any cause (for patients who have been loss to follow-up prior to death, the last follow-up time is calculated as the time of death).

  3 year

Secondary Outcomes (2)

• Progression-Free-Survival (PFS)

  3 year

• Lower extremities lymphedema

  3 year

Study Arms (2)

Control group

NO INTERVENTION

IB-IIA Cervical Cancer Patients with positive lymph node metastasis confirmed by intraoperative frozen pathological examination who will undergo radical hysterectomy and systematic pelvic lymphadenectomy

Experimental group

EXPERIMENTAL

IB-IIA Cervical Cancer Patients with positive lymph node metastasis confirmed by intraoperative frozen pathological examination who will undergo radical hysterectomy and selective enlarged lymph node dissection.

Procedure: Lymph nodes debulking surgery.

Interventions

Lymph nodes debulking surgery. PROCEDURE

Radical hysterectomy and selective enlarged lymph node dissection

Experimental group

Eligibility Criteria

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

You may qualify if:

• histology confirmed as cervical adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma.
• histological grading of cervical cancer is 1, 2, 3 or not.
• patients in the group must have no reproductive function requirements.
• Patients must be ≥ 18 years of age.
• preoperative: pelvic CT / MR or PET / CT suggest pelvic lymph node enlargement. Intraoperative: Patients with pelvic lymph node metastasis confirmed by freezing.
• Signed informed consent.
• Surgery should be completed within 4 weeks after the first diagnosis.
• patients can receive treatment and follow-up.

You may not qualify if:

• abdominal CT, PET / CT suggest that patients with para aortic lymph node metastasis.
• other history of the tumor, but does not include: received appropriate treatment of non-melanoma skin cancer, has been cured of other solid tumors, has been cured or non Hodgkin's lymphoma and Hodgkin's lymphoma 5 years without recurrence.
• Those who have received or will receive neoadjuvant chemotherapy.
• patients with preoperative limb lymphedema or lower extremity venous and lymphatic reflux disorders.
• pregnant women

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan university

Shanghai, Shanghai Municipality, 021, China

RECRUITING

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

• Xiaohua WU, PhD & MD

  Fudan university shanghai cancer center, Deparment of gynecologic oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shanhui Liang, Dr

CONTACT

008618616890863; dr_lianshanhui@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 28, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)