Nasopharyngeal Carcinoma Clinical Trial
Official title:
A Phase III Study of Radiotherapy With or Without Adjuvant Chemotherapy in Advanced Stage Nasopharyngeal Carcinoma Patients
Verified date | June 2009 |
Source | National Health Research Institutes, Taiwan |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
- To investigate the efficacy of adjuvant PFL chemotherapy after radiotherapy vs
radiotherapy alone in AJC stage IV nasopharyngeal carcinoma patients. The endpoints of
the study includes : overall survival, relapse free survival, distant metastasis and
local-regional control rates.
- To evaluate the toxicities of the two treatment methods.
Status | Terminated |
Enrollment | 320 |
Est. completion date | January 2000 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 70 Years |
Eligibility |
Inclusion Criteria: - Patients must have histologically proven nasopharyngeal carcinoma who have just completed curative radiotherapy treatment. - Original stage must be stage IV disease (M0) - Patients must have a complete response, partial response or stable disease assessed 4 weeks after radiotherapy. - Performance status scale ECOG grade 0,1. - Creatinine ? 1.5mg/dl and bilirubin ? 2.0mg/dl, WBC ? 3,000/mm3 and PLT ? 100,000/mm3,or Creatinine Clearance > 45ml/min if Creatinine > 1.5mg/dl. - Patients must be younger than 70 year-old. - Patients must give signed informed consent. Exclusion Criteria: - Patients had progressive disease after radiotherapy - Patients had evidence of distant metastasis. - Patients had completed radiotherapy for more than 7 weeks. - The presence of life-threatening illness - History of prior malignancy excluding basal cell carcinoma or squamous carcinoma of the skin or in-situ cervical cancer within 3 years of the diagnosis of NPC cancer. - Previous chemotherapy. - Pregnancy. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Veterans General Hospital-Taipei | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Health Research Institutes, Taiwan | Kaohsiung Medical University, Kaohsiung Veterans General Hospital., Mackay Memorial Hospital, National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | overall survival, relapse free survival,distant metastasis and local-regional control rates. | |||
Secondary | toxicities of the two treatment methods. |
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