Induction Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma

The University of Hong Kong-Shenzhen Hospital65 enrolled

Overview

To prospectively evaluate the short-term efficacy and toxicity of induction chemotherapy with cisplatin and capecitabine followed by concurrent chemoradiotherapy (CCRT) in the treatment of locally advanced nasopharyngeal carcinoma.

All patients received 3 cycles of induction chemotherapy:cisplatin 80mg/m2, day 1; oral capecitabine 1000mg/m2 twice daily from day1-14, repeated every 3 weeks followed by concomitant cisplatin (100mg/m2,day1,every 3 weeks) for a total of 2 cycles with radiotherapy. Intensity-modified radiotherapy (IMRT) were used in all patients with the total dose and dose/fraction (Fr) as follows: PTV (planned target volume)\_1:70 grays (Gy) at 2 Gy/ Fr, PTV\_2:63 Gy at 1.8 Gy/ Fr, PTV\_3:56 Gy at 1.6 Gy/ Fr;5 fractions per week. Tumor response was evaluated after 3 cycles of induction chemotherapy and 16 weeks following completion of CCRT according to the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST1.1). All toxicities were gauged based on the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE 4.03).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nasopharyngeal Carcinoma

Interventions

cisplatin, capecitabineDRUG

Experimental arm patients received 3 cycles of induction chemotherapy (cisplatin 80mg/m2, day 1; oral capecitabine 1000mg/m2 twice daily from day1-14, repeated every 3 weeks) followed by concomitant cisplatin (100mg/m2,day1,every 3 weeks) for a total of 2 cycles with radiotherapy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pathological confirmed nasopharyngeal carcinoma. * Staged as III to IVB. * 18-75 years old. * Performance status ≤2. * No previous chemotherapy or radiotherapy. * No concurrent malignancies or a history of other malignancies. * Adequate bone marrow function (absolute neutrophil count ≥1.5×109/L, platelets ≥100×109/L). * Adequate liver and renal function (serum bilirubin and serum transaminase levels less than twice the upper limit of normal, creatinine clearance ≥ 60ml/min). * Without serious co-morbidity. Exclusion Criteria: * Stage I-II or IVC. * Allergic to cisplatin or capecitabine * Age \<18 or \>75 * Performance Status \>2. * Without adequate bone marrow or liver function or renal function. * Severe co-morbidity and can not tolerate chemotherapy. * Other conditions not suitable for the study on the discretion of charging doctor.

Outcomes

Primary Outcomes

PFS (progression free survival)

progression free survival

Time frame: From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

Data from ClinicalTrials.gov

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