Different Surgical Approaches in Patients of Early-stage Cervical Cancer

NCT03739944 | Unknown Phase 3 DMC

• 1 other identifier: RACC
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

This multi-center, randomized controlled study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between Chinese uterine cervical patients receiving different surgical routes (laparotomy and laparoscopy) for radical hysterectomy or trachelectomy, which is the primary study objective. All patients with uterine cervical cancer of FIGO stage IA1 (with lymphovascular space invasion), IA2 and IB1 will be included and randomized into two groups: laparotomy and laparoscopy groups for radical hysterectomy or trachelectomy. Secondary study objectives include: patterns of recurrence, treatment-associated morbidity (6 months from surgery), cost-effectiveness, pelvic floor function, and quality of life.

Conditions

Uterine Cervical Neoplasm; Laparotomy; Laparoscopy; Survival; Mortality; Morbidity; Quality of Life; Pelvic Floor Disorders; Cost-Benefit Analysis

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

  Five years

Secondary Outcomes (3)

• Overall survival

  Five years

• Disease-free survival

  Five years

• Morbidity rate

  Six months

Other Outcomes (5)

• Cost-effectiveness of different surgical routes

  One year

• Quality of life

  Three years

• Sex function

  Five years

Study Arms (4)

Laparotomic radical hysterectomy

ACTIVE COMPARATOR

Procedure: Laparotomic radical hysterectomy

Laparotomic radical trachelectomy

ACTIVE COMPARATOR

Procedure: Laparotomic radical trachelectomy

Laparoscopic radical hysterectomy

ACTIVE COMPARATOR

Procedure: Laparoscopic radical hysterectomy

Laparoscopic radical trachelectomy

ACTIVE COMPARATOR

Procedure: Laparoscopic radical trachelectomy

Interventions

Laparotomic radical hysterectomy PROCEDURE

Laparotomic radical hysterectomy for patients without fertility requirement

Laparotomic radical hysterectomy

Laparotomic radical trachelectomy PROCEDURE

Laparotomic radical hysterectomy for patients with fertility requirement

Laparotomic radical trachelectomy

Laparoscopic radical hysterectomy PROCEDURE

Laparoscopic radical hysterectomy for patients without fertility requirement

Laparoscopic radical hysterectomy

Laparoscopic radical trachelectomy PROCEDURE

Laparoscopic radical hysterectomy for patients with fertility requirement

Laparoscopic radical trachelectomy

Eligibility Criteria

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

You may qualify if:

• Confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
• FIGO stage IA1 (with lymphovascular space invasion), IA2 or IB1
• Type II or III radical hysterectomy or trachelectomy
• Performance status of ECOG 0-1
• Aged 18 years or older
• Signed an approved informed consents

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (3)

• Chao X, Li L, Wu M, Wu H, Ma S, Tan X, Zhong S, Lang J. Minimally invasive versus open radical trachelectomy for early-stage cervical cancer: protocol for a multicenter randomized controlled trial in China. Trials. 2020 Dec 14;21(1):1022. doi: 10.1186/s13063-020-04938-3.

  PMID: 33317612 DERIVED

• Ferrandina G, Corrado G, Scambia G. Minimally invasive surgery and quality of life in cervical cancer. Lancet Oncol. 2020 Jun;21(6):746-748. doi: 10.1016/S1470-2045(20)30161-3. No abstract available.

  PMID: 32502439 DERIVED

• Chao X, Li L, Wu M, Ma S, Tan X, Zhong S, Lang J, Cheng A, Li W. Efficacy of different surgical approaches in the clinical and survival outcomes of patients with early-stage cervical cancer: protocol of a phase III multicentre randomised controlled trial in China. BMJ Open. 2019 Jul 29;9(7):e029055. doi: 10.1136/bmjopen-2019-029055.

  PMID: 31362966 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Pelvic Floor Disorders

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; Pregnancy Complications; Male Urogenital Diseases

Central Study Contacts

Lei Li, M.D.

CONTACT

13911988831; lileigh@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 14, 2018
• Study Start: November 23, 2018
• Primary Completion: November 23, 2022
• Study Completion: November 23, 2023
• Last Updated: December 28, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The data will be available once the papers were accepted and be available for ever

Locations

CN (1)