Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in Defined Poor-Prognostic Cervical Cancer

January 3, 2010 updated by: Chang Gung Memorial Hospital

Phase III Trial for Primary Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in PET/CT Defined Poor-Prognostic Cervical Cancer Patients

Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. However, in patients with advanced cervical cancer, half of them treated with contemporary radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. How to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation.

The major aim of this project is to conduct a prospective, randomized phase III clinical trial to examine if cervical cancer patients treated by radiotherapy with cisplatin and gemcitabine have better survival rates than those treated by radiotherapy with cisplatin alone.

Gemcitabine has been demonstrated to be a good radiosensitizer. In keeping with this, few clinical trials in early phases showed promising results when using concurrent radiotherapy with cisplatin and gemcitabine. According to these positive results, the investigators expect this trial has the potential to improve the survival in patients with advanced cervical cancer, reduce the medical costs due to tumor relapse, and then benefit the whole society.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

I). Study end points Primary end point: Patient survival, including overall survival and progression-free survival.

Secondary end points:

  1. Acute toxicity during treatment
  2. Tumor response rates
  3. Sites of recurrence
  4. Long-term complications and quality of life II). Design of study

An open-label, prospective randomized trial with two treatment arms:

  • Arm I: Patients receive CCRT with weekly cisplatin only.
  • Arm II: Patients receive CCRT with cisplatin plus gemcitabine. III). Study population 1) Number of subjects: A total of 172 patients (86 per treatment arm) will be accrued for this study within 4 years.

Conduct of study

Study Type

Interventional

Enrollment (Anticipated)

172

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

  • Taiwan
      • Kaohsiung, Taiwan, M.D
        • Chong Jong Wang,
      • Keelung, Taiwan
        • Chien-Sheng Tsai

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

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically confirmed primary squamous cell carcinoma of the uterine cervix.
  • Previously untreated disease.
  • Clinical FIGO stage III-IVa or pelvic/para-aortic lymph node positive by PET examination.
  • No known metastases to supraclavicular nodes or other organs outside the radiotherapy field.
  • Ages eligible: 35 years - 70 years.
  • Patients must have adequate bone marrow, pulmonary, liver and renal function documented before radiotherapy. WBC > 3000/mm3, platelet > 100,000/mm3, serum transaminases (GOT, GPT) < 60 IU/ml, total bilirubin < 1.5mg%, creatinine < 1.4mg% (creatinine clearance > 60 ml/min).
  • Performance status 0 or 1 (see Appendix I).
  • The interval between RT and randomization is not greater than 3 weeks.
  • Patients must have signed informed consent to participate this study.

Exclusion Criteria:

  • Age > 70 or < 35
  • Medical or psychological condition that would preclude treatment.
  • Previous chemotherapy or pelvic RT.
  • Small cell carcinoma, adenocarcinoma or adenosquamous carcinoma.
  • Patient unreliable for treatment completion and follow-up.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gemzar,survival
Drug: Gemzar (gemcitabine)
Gemzar(gemcitabine) Hcl has 2'deoxy-2,2'-difluorouridine monohydrochloride
Other Names:
  • GEMCITABINE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient survival, including overall survival and progression-free survival.
Time Frame: 2012,
2012,

Secondary Outcome Measures

Outcome Measure
Time Frame
1) Acute toxicity during treatment 2) Tumor response rates 3) Sites of recurrence 4) Long-term complications and quality of life
Time Frame: 2013
2013

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Collaborators

Eli Lilly and Company

Investigators

  • Principal Investigator: Chun Chieh Wang, MD, Chang Gung Memorial Hospital

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

February 1, 2009

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

February 8, 2009

First Submitted That Met QC Criteria

February 11, 2009

First Posted (Estimate)

February 12, 2009

Study Record Updates

Last Update Posted (Estimate)

January 5, 2010

Last Update Submitted That Met QC Criteria

January 3, 2010

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97-1165A3

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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