MedTrace Logo

Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer

NCT01999933 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2013-12-03

No results posted yet for this study

Summary

The present study is a randomized, control, phase II/III study of early stage (FIGO Ia2-IIb) cervical cancer after radical hysterectomy in Northwest China treated with radiotherapy or concurrent chemoradiotherapy based on the surgical-pathological risk factors. All the patients received whole pelvis radiation and were divided into three groups according to adjuvant chemotherapy: concurrent chemotherapy with cisplatin weekly (40mg/m2) , concurrent chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), or concurrent and adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2). The effectiveness, and side effects will be evaluated according to Standard WHO response criteria, and NCI common toxicity criteria for adverse events(NCI-CTC-AE) V3.0.

Conditions

Interventions

RADIATION

Radiation

Arm1, Arm2 and Arm3 patients should received the whole pelvic radiation.

DRUG

cisplatin（DDP） weekly

concurrent chemotherapy with cisplatin（DDP） weekly(40mg/m2),begin with radiation

DRUG

docetaxel plus cisplatin

concurrent docetaxel plus cisplatin tri-weekly (75mg/m2),2 cycles, begin with radiation

DRUG

docetaxel plus cisplatin

adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), 4 cycles after radiation

Sponsors & Collaborators

  • Mei Shi

    lead OTHER

Principal Investigators

  • Mei Shi, MD · department of radiation oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-11-30
Completion
2018-11-30

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 NCT01999933 on ClinicalTrials.gov