Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial

This is an randomized controlled, multicenter 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 high risk nasopharyngeal carcinoma.

Study Overview

• Status: Completed
• 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 (Actual): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Cancer Center, Sun Yat-sen University

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 7th)
• Meet at least one factor below :1 primary tumor SUVmax>10 in 18F-FDG PET/CT;2 primary tumor volume>30cm3;3 mutiple metastatic cervical lymph node with at least one's short diameter>4cm; 4 T4N2M0; 5 T1-4N3M0;6 EBV-DNA>2×10E4 copy/l
• Range from 18～70 years old
• WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
• ALT or AST < 2.5×ULN、bilirubin < 1.5×ULN
• OSerum creatinine < 1.5×ULN

Exclusion Criteria:

• Central nervous system metastases
• Suitable for local treatment
• Uncontrolled seizure disorder or other serious neurologic disease
• Clinically significant cardiac or respiratory disease
• Drug or alcohol addition
• Do not have full capacity for civil acts
• Severe complication, active infection
• Concurrent immunotherapy or hormone therapy for other diseases
• Pregnancy or lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

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) every three weeks for three cycles during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles.
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) every three weeks for three cycles during RT.

What is the study measuring?

Primary 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.	3-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Toxicity	To evaluate the acute toxicity with CTC 3.0 when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used.	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Locoregional relapse free survival	Defined as the time from date of recruitment to documented locoregional relapse or death from any cause.	3-year
Distance metastasis free survival	Defined as the time from date of recruitment to documented distant metastatic recurrence or death from any cause.	3-year
Overall survival rate	Defined as the time from date of recruitment to death from any cause.	3-year
Late Toxicity	To evaluate the late toxicity with the RTOG/EORTC criterion when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used.	3 years

Collaborators and Investigators

• Sponsor: Zhao Chong
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Jiangxi Provincial Cancer Hospital; National Cancer Centre, Singapore

Publications and helpful links

General Publications

• Miao J, Wang L, Tan SH, Li JG, Yi J, Ong EHW, Tan LLY, Zhang Y, Gong X, Chen Q, Xiang YQ, Chen MY, Guo Y, Lv X, Xia WX, Tang L, Deng X, Guo X, Han F, Mai HQ, Chua MLK, Zhao C. Adjuvant Capecitabine Following Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2022 Oct 13;8(12):1776-85. doi: 10.1001/jamaoncol.2022.4656. Online ahead of print.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 31, 2014
• Primary Completion (ACTUAL): July 27, 2018
• Study Completion (ACTUAL): August 5, 2022

Study Registration Dates

• First Submitted: May 7, 2014
• First Submitted That Met QC Criteria: May 18, 2014
• First Posted (ESTIMATE): May 21, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 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-LAHR-NPC