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

Phase 3

Active, not recruiting

• Conditions: Local Advanced High Risk Nasopharyngeal Carcinoma
• Interventions: Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy; Drug: IMRT combine with cisplatin concurrent chemotherapy

• Registration Number: NCT02973386
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-25
• Study Start: 2017-01
• Primary Completion: 2022-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-27
• Last Update Posted: 2024-05-29
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 278

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concurrent chemoradiation + adjuvant chemotherapy	IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy	IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
Concurrent chemoradiation	IMRT combine with cisplatin concurrent chemotherapy	IMRT combine with cisplatin concurrent chemotherapy

Primary Outcome Measures

Name	Time	Method
Distant metastasis-free survival	Five year	Defined as the time from date of recruitment to documented distant metastasis or death from any cause.

Secondary Outcome Measures

Name	Time	Method
Locoregional relapse-free survival	Five year	Defined as the time from date of recruitment to documented locoregional relapse or death from any cause.
Overall survival	Five year	Defined as the time from date of recruitment to death from any cause.
Acute toxicity	three months after corresponding treatment	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.
Late toxicity	Five year	Late toxicities were assessed annually using the RTOG radiation morbidity scoring criteria.
Failure-free survival	Five year	Defined as the time from date of recruitment to documented relapse or death from any cause.

Trial Locations

Locations (1)

Cancer Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China