Comparing Study Between Concurrent Chemoradiation and New Combination Treatment in Cervical Cancer Patients

NCT01000415 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 824

Last updated 2010-06-24

No results posted yet for this study

Summary

The purpose of this study is:

* to compare the effectiveness between the new strategy of treatment (given cis-platinum plus gemcitabine-neoadjuvant chemotherapy followed by surgery),and standard treatment (given cis-platinum/carboplatin during radiation-concurrent chemoradiation)in specific group of cervical cancer patients (stage Ib2-early IIb)
* to evaluate quality of life in both group of patients(standard treatment vs.experimental group)

Conditions

Interventions

OTHER

Neoadjuvant chemotherapy followed by surgery

Cisplatin 50 mg/m2 (in the vein)on day 1 of each 23 day cycle plus gemcitabine 1000 mg/m2 (in the vein) on day 1 and day 8, for 3 cycles: until progression or unacceptable toxicity develops.

Sponsors & Collaborators

  • National Research Council of Thailand

    collaborator OTHER_GOV
  • Clinical Research Collaborative Network

    collaborator NETWORK
  • Thai Gynecologic Oncology Collaborative Group

    lead NETWORK

Principal Investigators

  • Saibua B. Chichareon, MD. · Thai Gynecologic Oncology Collaborative Group (TGOC)

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
2009-06-30
Primary Completion
2013-09-30
Completion
2018-06-30

Countries

  • Thailand

Study Locations

More Related Trials

Entities

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 NCT01000415 on ClinicalTrials.gov