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Randomized Control Trial on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy for the Cervical Cancer

NCT02703961 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 598

Last updated 2016-03-17

No results posted yet for this study

Summary

The standard treatment of local advanced cervical cancer is concurrent chemoradiotherapy. The 3 year disease free survival was about 50-70%. The distant metastasis is the main cause of failure in local advanced cervical cancer treated with 3-dimensional conformal radiotherapy (3D-CRT) or intensity modulated radiotherapy (IMRT). The purpose of this study is to investigate the efficacy and tolerance of concurrent and adjuvant chemotherapy with cisplatin and docetaxel for local advanced cervical cancer. It was expected that the 3 year disease free survival would be increased by 10% with this new treatment schedule.

Conditions

Interventions

DRUG

concurrent chemotherapy with cisplatin

in experimental group: cisplatin 60mg/m2, d1,d22;

DRUG

concurrent chemotherapy with docetaxel

in experimental group: docetaxel 60mg/m2, d1,d22;

RADIATION

pelvic radiotherapy

external beam radiotherapy for whole pelvix with 50Gy/25f boost radiotherapy for pelvic lymph node metastasis with 12-14Gy/4-7f.

RADIATION

brachytherapy

CT/MRI guided brachytherapy or x-ray guided brachytherapy

DRUG

adjuvant chemotherapy with cisplatin and docetaxel

cisplatin 75mg/m2, d43,d64; docetaxel 75mg/m2, d43,d64

Sponsors & Collaborators

  • Air Force Military Medical University, China

    lead OTHER

Principal Investigators

  • mei shi, professor · Xijing Hospital, the Fourth Military Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-02-28
Completion
2021-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02703961 on ClinicalTrials.gov