A Multicenter Trial Comparing Induction C/T Followed by CCRT v.s. CCRT Alone in Stage IV Nasopharyngeal Carcinoma

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Investigate the effect of induction MEPFL chemotherapy followed by concurrent chemoradiotherapy (CCRT) on the disease control and survival in treatment of patients with advanced NPC.

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

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Collaborators: Chang Gung Memorial Hospital; Changhua Christian Hospital; Chi Mei Medical Hospital; China Medical University Hospital; Chung Shan Medical University; Kaohsiung Medical University Chung-Ho Memorial Hospital; Kaohsiung Veterans General Hospital.; National Taiwan University Hospital; Taipei Veterans General Hospital, Taiwan; Tri-Service General Hospital
• Treatments: Cisplatin; Epirubicin; Fluorouracil; Leucovorin; Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

• Histologically proved nasopharyngeal carcinoma.

• T4NxM0 or TxN3M0 disease by UICC/AJCC 1997 staging system. (30)

• Eastern Cooperative Oncology Group performance status < 2.

• A leukocyte count ≥3750/mL, Hb ≥ 10 g/dL, and a platelet count ≥100,000/mL.

• A serum bilirubin level < 1.5 mg/dL, serum creatinine level < 1.6 mg/dL or creatinine clearance > 60 mL/min.

• Age less than 70 years old

• An informed consent signed.

Exclusion Criteria:

• Evidence of metastatic disease.

• Presence of another malignancy other than treated squamous/basal cell carcinoma of the skin.

• Presence of uncontrolled hypertension, poorly controlled heart failure.

• Presence of active infection.

• Patients who have been or are being treated with chemotherapy, radiotherapy, immunotherapy, or other experimental therapies.

• Women who test positive for pregnancy.