A Phase III Study of Radiotherapy With or Without Adjuvant C/T in Advanced Stage Nasopharyngeal Carcinoma Patients

• Status: Terminated
• Trial end date: 2000-01-01
• Target enrollment: 0
• Participant gender: All

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 survival, relapse free survival, distant metastasis and local-regional control rates.

• To evaluate the toxicities of the two treatment methods.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Collaborators: Kaohsiung Medical University; Kaohsiung Veterans General Hospital.; Mackay Memorial Hospital; National Taiwan University Hospital; Taipei Veterans General Hospital, Taiwan; Tri-Service General Hospital
• Treatments: Leucovorin

Criteria

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.