Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in Defined Poor-Prognostic Cervical Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Drug: Gemzar (gemcitabine) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase III Trial for Primary Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in PET/CT Defined Poor-Prognostic Cervical Cancer Patients |
- Patient survival, including overall survival and progression-free survival. [ Time Frame: 2012, ] [ Designated as safety issue: Yes ]
- 1) Acute toxicity during treatment 2) Tumor response rates 3) Sites of recurrence 4) Long-term complications and quality of life [ Time Frame: 2013 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 172 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Gemzar,survival |
Drug: Gemzar (gemcitabine)
Gemzar(gemcitabine) Hcl has 2'deoxy-2,2'-difluorouridine monohydrochloride
Other Name: GEMCITABINE
|
Detailed Description:
I). Study end points Primary end point: Patient survival, including overall survival and progression-free survival.
Secondary end points:
- Acute toxicity during treatment
- Tumor response rates
- Sites of recurrence
- 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
Eligibility| Ages Eligible for Study: | 35 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Taiwan | |
| Chong Jong Wang, | |
| Kaohsiung, Taiwan, M.D | |
| Chien-Sheng Tsai | |
| Keelung, Taiwan | |
| Principal Investigator: | Chun Chieh Wang, MD | Chang Gung Memorial Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00842660 History of Changes |
| Other Study ID Numbers: | 97-1165A3 |
| Study First Received: | February 8, 2009 |
| Last Updated: | January 3, 2010 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Chang Gung Memorial Hospital:
|
Cervical cancer concurrent chemoradiotherapy gemcitabine |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Gemcitabine Cisplatin Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013