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

NCT ID: NCT02973386

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 294 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-13
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Local Advanced High Risk Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Concurrent chemoradiation + adjuvant chemotherapy

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

Group Type: EXPERIMENTAL

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

Intervention Type: DRUG

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.

Concurrent chemoradiation

IMRT combine with cisplatin concurrent chemotherapy

Group Type: ACTIVE_COMPARATOR

IMRT combine with cisplatin concurrent chemotherapy

Intervention Type: DRUG

Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT.

Interventions

IMRT combine with cisplatin concurrent chemotherapy

Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT.

Intervention Type: DRUG

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhao Chong

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

zhao chong, M.D

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Related Links

http://www.sysucc.org.cn

Home Page of Cancer Center, Sun Yat-sen University

Other Identifiers

CCRT-AC-HRDM-NPC

Identifier Type: -

Identifier Source: org_study_id