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

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Local Advanced High Risk Nasopharyngeal Carcinoma

Treatments: Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy; Drug: IMRT combine with cisplatin concurrent chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02973386

CCRT-AC-HRDM-NPC

Details and patient eligibility

About

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.

Enrollment: 294 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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294 participants in 2 patient groups

Concurrent chemoradiation + adjuvant chemotherapy

Experimental group

Description:

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

Treatment:

Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

Concurrent chemoradiation

Active Comparator group

Description:

IMRT combine with cisplatin concurrent chemotherapy

Treatment:

Drug: IMRT combine with cisplatin concurrent chemotherapy