A Phase 3 interventional study of IMRT combine with cisplatin concurrent chemotherapy and IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma, sponsored by Zhao Chong. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-08-31.
Sponsored by Zhao Chong · Phase 3, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's enrollment of 180 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Zhao Chong is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
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.
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.
Failure free survival
Defined as the time from date of recruitment to documented relapse or death from any cause.
Time frame: 3-year
Acute Toxicity
To evaluate the acute toxicity with CTC 3.0 when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used.
Time frame: 18 months
Locoregional relapse free survival
Defined as the time from date of recruitment to documented locoregional relapse or death from any cause.
Time frame: 3-year
Distance metastasis free survival
Defined as the time from date of recruitment to documented distant metastatic recurrence or death from any cause.
Time frame: 3-year
Overall survival rate
Defined as the time from date of recruitment to death from any cause.
Time frame: 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.
Time frame: 3 years
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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