Prognostic Analysis of Concurrent Chemoradiotherapy With/Without Adjuvant Chemotherapy for Locally Advanced NPC Patients

Sun Yat-sen University294 enrolled

Overview

This is a randomized,controlled,prospective phase III clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.Exploring an Individualized comprehensive treatment plan which is reasonable,effective,low toxicity and fitting with Modern radiotherapy techniques for Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

294

Conditions

Local Advanced High Risk Nasopharyngeal Carcinoma

Interventions

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapyDRUG

Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles at 4 weeks later after RT.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III) * Clinical stage III\~IVb(UICC/AJCC 7th) * No distant metastasis * Karnofsky Performance Status Scale≥70 * WBC count ≥ 4×109/L, neutrophil differential count≥ 1.5×109/L, Hemoglobin ≥ 90g/L, platelet count ≥ 100×109/L * ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN, Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min * Sign the informed consent. Exclusion Criteria: * Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell carcinomas * Younger than 18 years old or older than 70 years old * Are receiving other drugs treanment * kidney disease * Have suffered from other tumor or now suffering from other tumor * Have recieved chemotherapy or radiotherapy * Pregnancy or lactation * unstable heart disease need timely treatment * Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes

Outcomes

Primary Outcomes

Distant metastasis-free survival

Defined as the time from date of recruitment to documented distant metastasis or death from any cause.

Time frame: Five year

Secondary Outcomes

Failure-free survival

Defined as the time from date of recruitment to documented relapse or death from any cause.

Time frame: Five year

Locoregional relapse-free survival

Defined as the time from date of recruitment to documented locoregional relapse or death from any cause.

Time frame: Five year

Overall survival

Defined as the time from date of recruitment to death from any cause.

Time frame: Five year

Acute toxicity

Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0) for chemotherapy-specific toxicities, and the Radiation Therapy Oncology Group (RTOG) radiation morbidity scoring criteria for radiotherapy-specific toxicities.

Time frame: three months after corresponding treatment

Late toxicity

Late toxicities were assessed annually using the RTOG radiation morbidity scoring criteria.

Time frame: Five year

Prognostic Analysis of Concurrent Chemoradiotherapy With/Without Adjuvant Chemotherapy for Locally Advanced NPC Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes