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

Sponsor

Zhao Chong (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02143388

Collaborator

Jiangxi Provincial Cancer Hospital (Other), Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other), National Cancer Centre, Singapore (Other)

180

Enrollment

Location

Arms

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Local Advanced High Risk Nasopharyngeal Carcinoma	Drug: IMRT combine with cisplatin concurrent chemotherapy Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 31, 2014

Actual Primary Completion Date :

Jul 27, 2018

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Failure free survival [3-year]
Defined as the time from date of recruitment to documented relapse or death from any cause.

Secondary Outcome Measures

Acute Toxicity [18 months]
To evaluate the acute toxicity with CTC 3.0 when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used.

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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