Status:
UNKNOWN
Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in Defined Poor-Prognostic Cervical Cancer
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Cervical Cancer
Eligibility:
FEMALE
35-70 years
Phase:
PHASE3
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00842660
Start Date
February 1 2009
End Date
January 1 2013
Last Update
January 5 2010
Active Locations (2)
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1
Chong Jong Wang,
Kaohsiung City, Taiwan, M.D
2
Chien-Sheng Tsai
Keelung, Taiwan