NCT07248670

Concurrent Chemoradiotherapy With or Without Metronomic Capecitabine in High-Risk T1-2N1M0 NPC

Concurrent Chemoradiotherapy With or Without Metronomic Capecitabine in High-Risk T1-2N1M0 Nasopharyngeal Carcinoma: A Multicenter, Randomized Controlled, Phase III Clinical Study

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: Chongqing University Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This Phase III multicenter trial investigates treatment intensification for high-risk, stage T1-2N1M0 nasopharyngeal carcinoma. Patients with high-risk features (\>3 metastatic lymph nodes, necrosis, or confluence) receive concurrent chemoradiotherapy. Those with detectable EBV DNA during radiotherapy are randomized 1:1 to adjuvant capecitabine or observation alone to assess efficacy and safety

Detailed description

This is a multicenter, randomized, phase III trial enrolling patients with AJCC/UICC 9th edition stage T1-2N1M0 nasopharyngeal carcinoma who have at least one of the following high-risk features: more than 3 metastatic cervical lymph nodes, presence of nodal necrosis, or presence of nodal confluence. All patients receive concurrent chemoradiotherapy (CCRT) with a weekly cisplatin regimen. Plasma EBV DNA is monitored weekly during CCRT. High-risk patients with detectable EBV DNA at any time from the second week of CCRT until the end of radiotherapy are randomized in a 1:1 ratio to receive either metronomic adjuvant chemotherapy with capecitabine or follow-up observation alone, to evaluate the efficacy and safety of treatment intensification

Conditions

• Nasopharyngeal Cancinoma (NPC)

Interventions

Type	Name	Description
DRUG	metronomic adjuvant chemotherapy with capecitabine	The concurrent chemoradiotherapy (CCRT) regimen consisted of IMRT delivering 69.96 Gy in 33 fractions, combined with cisplatin administered at 35-40 mg/m² weekly for 6 cycles to achieve a cumulative dose of ≥200 mg/m². During CCRT, plasma EBV DNA titer was monitored weekly. If EBV DNA remained undetectable from the second week after CCRT initiation until the end of radiotherapy, patients underwent observation after radiotherapy. If EBV DNA was detectable at any time point from the second week of CCRT until the end of radiotherapy, patients were randomized in a 1:1 ratio to observation or metronomic adjuvant chemotherapy with capecitabine (650 mg/m² twice daily, Q3W) for 8 cycles (6 months) after radiotherapy.

Timeline

• Start date: 2025-10-04
• Primary completion: 2031-12-31
• Completion: 2031-12-31
• First posted: 2025-11-25
• Last updated: 2025-11-25

Locations

1 site across 1 country: China