Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in

Status Enrolling by invitation

Clinical Trial Summary

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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00842660
Study type	Interventional
Source	Chang Gung Memorial Hospital
Contact
Status	Enrolling by invitation
Phase	Phase 3
Start date	February 2009
Completion date	January 2013

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms