NCT02973386

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: Sun Yat-Sen University Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Local Advanced High Risk Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2017-01-13
• Primary completion: 2022-10-25
• Completion: 2025-12-01
• First posted: 2016-11-25
• Last updated: 2026-02-05

Locations

1 site across 1 country: China