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Different Surgical Approaches in Patients of Early-stage Cervical Cancer

NCT ID: NCT03739944

Last Updated: 2018-12-28

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-23

Study Completion Date

2023-11-23

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Laparotomic radical hysterectomy

Group Type ACTIVE_COMPARATOR

Laparotomic radical hysterectomy

Intervention Type PROCEDURE

Laparotomic radical hysterectomy for patients without fertility requirement

Laparotomic radical trachelectomy

Group Type ACTIVE_COMPARATOR

Laparotomic radical trachelectomy

Intervention Type PROCEDURE

Laparotomic radical hysterectomy for patients with fertility requirement

Laparoscopic radical hysterectomy

Group Type ACTIVE_COMPARATOR

Laparoscopic radical hysterectomy

Intervention Type PROCEDURE

Laparoscopic radical hysterectomy for patients without fertility requirement

Laparoscopic radical trachelectomy

Group Type ACTIVE_COMPARATOR

Laparoscopic radical trachelectomy

Intervention Type PROCEDURE

Laparoscopic radical hysterectomy for patients with fertility requirement

Interventions

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Laparotomic radical hysterectomy

Laparotomic radical hysterectomy for patients without fertility requirement

Intervention Type PROCEDURE

Laparotomic radical trachelectomy

Laparotomic radical hysterectomy for patients with fertility requirement

Intervention Type PROCEDURE

Laparoscopic radical hysterectomy

Laparoscopic radical hysterectomy for patients without fertility requirement

Intervention Type PROCEDURE

Laparoscopic radical trachelectomy

Laparoscopic radical hysterectomy for patients with fertility requirement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lei Li

OTHER

Sponsor Role lead

Responsible Party

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Lei Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Lei Li

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Li, M.D.

Role: CONTACT

Phone: 13911988831

Email: [email protected]

Facility Contacts

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Lei Li, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 33317612 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32502439 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31362966 (View on PubMed)

Other Identifiers

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RACC

Identifier Type: -

Identifier Source: org_study_id