The Value of Single-cycle TPF Induction Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Two Phase Ⅲ trials (TAX323 and TAX324) showed induction chemotherapy adding docetaxel to cisplatin plus fluorouracil (TPF) could significant improve survival in head and neck cancer, and a Phase Ⅱ trial from Hong Kong by Hui and colleges with this strategy has also been reported in nasopharyngeal carcinoma (NPC). However, whether three cycles induction could delay the whole time of treatment and reduce the survival benefit are still unknown. A retrospective study of one cycle TPF induction chemotherapy by the investigators group (not yet published) could improve survival in NPC. It encourage us to conduct this clinical trial.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First People's Hospital of Foshan
• Treatments: Cisplatin; Docetaxel; Fluorouracil

Criteria

Inclusion Criteria:

• Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO 2005) histologically type).

• Satisfactory performance status: Karnofsky scale (KPS) > 70.

• Tumor staged is according to the 7th American Joint Commission on Cancer edition as Stage III：T1-2N2M0, T3N0-2M0 Stage IVa：T4N0-2M0

• Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.

• Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.

• Adequate renal function: creatinine clearance ≥60 ml/min.

Exclusion Criteria:

• Age >60 years or <18 years.

• Pregnancy or lactation.

• Treatment with palliative intent.

• Prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes.

• Any severe intercurrent disease including unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control and emotional disturbance.