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

June 23, 2010 updated by: Thai Gynecologic Oncology Collaborative Group

Comparing Standard Concurrent Chemo-radiation to Neoadjuvant Chemotherapy Then Surgery or Radiation in Patients Stage Ib2-early IIb Cervical Carcinoma

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

According to FIGO classification of cervical cancer, stage Ib2 was classified as clinically visible lesion more than 4.0 cm in greatest dimension and stage IIb was classified tumor invades parametrium must not to pelvic wall. These were the common stages in Thai cervical cancer patients,and made a troublesome effect to Thai women. According to this study,stage early IIb with 1/3 of parametrium involvement. Mostly these two stage was treated with concurrent chemoradiation, challenging the possibility of late sequelae of radiation effect. This specific group of patients can be avoid the referred side effect by using neoadjuvant chemotherapy followed by radical hysterectomy with pelvic lymphadenectomy and para-aortic node sampling in operable cases (at least partial response- PR) and concurrent chemoradiation (CCR) in inoperable cases (less than PR). Due to high risk type of these subspecific group, combination chemotherapy instead of single chemotherapy was used as CCR. However in operable cases with identified poor prognostic factor should be receive post operative radiation as the usual manner.

Study Type

Interventional

Enrollment (Anticipated)

824

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Songkhla
      • Hat-Yai, Songkhla, Thailand, 90110
        • Recruiting
        • Gynecologic Oncology Unit, Department of Obstertrics and Gynecology, Faculty of medicine, Prince of Songkla University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rakchai - Buhachat, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Cervical cancer patients with FIGO stage Ib2-early IIb
  • Pathological proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma
  • ECOG performance status 0-1
  • No previous treatment for cervical cancer
  • Acceptable hematological,renal,liver function

Exclusion Criteria:

  • Previous history of cancer
  • Underlying disease not fit for surgery
  • Psychological problem
  • Obvious pelvic/para-aortic node involvement
  • Pregnancy
  • HIV positive
  • History of bowel obstruction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cisplatin plus gemcitabine
Experimental arm: neoadjuvant chemotherapy (cisplatin plus gemcitabine) followed by surgery Control arm: concurrent chemoradiation (cisplatin/carboplatin)during standard radiation
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.
Other Names:
  • Gemzar
  • Platinol,Platinol-AQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival comparison between experimental treatment group and standard treatment group
Time Frame: 9 Years
9 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparing disease free survival between experimental treatment group and standard treatment group
Time Frame: 9 years
9 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thai Gynecologic Oncology Collaborative Group

Collaborators

National Research Council of Thailand
Clinical Research Collaborative Network

Investigators

  • Principal Investigator: Saibua B. Chichareon, MD., Thai Gynecologic Oncology Collaborative Group (TGOC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria

October 22, 2009

First Posted (Estimate)

October 23, 2009

Study Record Updates

Last Update Posted (Estimate)

June 24, 2010

Last Update Submitted That Met QC Criteria

June 23, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGOC-03
  • ECPSU-522231012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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