Status:
TERMINATED
A Phase III Study of Radiotherapy With or Without Adjuvant C/T in Advanced Stage Nasopharyngeal Carcinoma Patients
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
National Taiwan University Hospital
Tri-Service General Hospital
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE3
Brief Summary
* 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 sur...
Detailed Description
The head and neck contracts study tested induction and maintenance chemotherapy in patients with advanced head and neck cancers.There were no significant differences in survival between the two groups...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 1994
Trial Type :
INTERVENTIONAL
End Date :
January 1 2000
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00201344
Start Date
November 1 1994
End Date
January 1 2000
Last Update
March 26 2010
Active Locations (1)
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1
Veterans General Hospital-Taipei
Taipei, Taiwan, 112