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

Randomized Trial of Concurrent Cisplatin Chemoradiotherapy Plus Capecitabine Adjuvant Chemotherapy vs Concurrent Cisplatin Chemoradiotherapy Alone for Patients With Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis

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 Overview

• Status: Recruiting
• Conditions: Local Advanced High Risk Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy; Drug: IMRT combine with cisplatin concurrent chemotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 278
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: wu haijun; Phone Number: +86-18819200847; Email: wuhj@sysucc.org.cn
• Study Contact Backup: Name: miao jingjing; Phone Number: +86-13631355201; Email: miaojj@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Cancer Center, Sun Yat-sen University
      • Contact: Zhao chong, M.D; Phone Number: +86-13902206160; Email: zhaochong@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Concurrent chemoradiation + adjuvant chemotherapy; IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy	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.
Active Comparator: Concurrent chemoradiation; IMRT combine with cisplatin concurrent chemotherapy	Drug: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Publications and helpful links

Helpful Links

• Home Page of Cancer Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: November 22, 2016
• First Posted (Estimate): November 25, 2016

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 9, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: High Risk; Nasopharyngeal Carcinoma; Local advanced
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Cisplatin; Capecitabine
• Other Study ID Numbers: CCRT-AC-HRDM-NPC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No