Effect of Triple Combination of Induction, Concurrent and Adjuvant Chemotherapy in High Risk Nasopharyngeal Carcinoma

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators aim to evaluate the survival benefit from triple combination of induction, concurrent and aduvant chemotherapy versus concurrent chemotherapy alone for high risk locoregionally advanced nasopharyngeal carcinoma treated with intensity-modulated radiotherapy.

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

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Affiliated Cancer Hospital & Institute of Guangzhou Medical University; Affiliated Tumor Hospital of Guangzhou Medical University; The First Affiliated Hospital of Guangdong Pharmaceutical University; The First Affiliated Hospital of Guangzhou Medical University
• Treatments: Capecitabine; Cisplatin; Docetaxel

Criteria

Inclusion Criteria:

• Newly histologically confirmed non-keratinizing (WHO 1991) nasopharyngeal carcinoma.

• Tumor staged as T4N0-3M0 or T1-3N3M0 (the 2010 UICC/AJCC staging system).

• Pretreatment EBV DNA ≥ 4000 copies/mL.

• Karnofsky scale (KPS) ≥ 70.

• Adequate marrow: leucocyte count ≥ 4×10E9/L, hemoglobin ≥ 110g/L and platelet count ≥ 100×10E9/L.

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

• Adequate renal function: creatinine clearance ≥ 60 ml/min or creatinine ≤ 1.5×ULN.

• Patients must give written informed consent.

Exclusion Criteria:

• Prior malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.

• Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).

• History of previous radiotherapy (except for non-melanomatous skin cancers outside intended radiotherapy volume).

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

• Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.

• Dihydropyrimidine dehydrogenase deficiency.