NCT04061278

A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study for the Treatment of N2-3 Nasopharyngeal Carcinoma Patients

A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study Comparing 4 Cycles of Neoadjuvant Chemotherapy Combined With Radiotherapy Versus 3cycles of Neoadjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy for the Treatment of N2-3 Nasopharyngeal Carcinoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

At the initial diagnosis of locally advanced nasopharyngeal carcinoma, a considerable proportion of patients have developed distant metastasis, forming subclinical lesions. Nowadays, with the advent of intensity modulated radiotherapy, the local-regional area is under well controlled. However, distant metastasis is still the main cause of failure in treatment of stage N2-3 nasopharyngeal carcinoma.The severe toxicity of synchronous chemotherapy and the dose intensity of single drug is not enough to effectively control existing subclinical lesions. Neoadjuvant chemotherapy with sufficient intensity (four cycles) can possible effectively kill subclinical lesions prior to the initiation of concurrent chemoradiotherapy, thereby reducing distant metastasis of stage N2-3 nasopharyngeal carcinoma. Meanwhile, four cycles of chemotherapy have been shown to be well tolerated in other tumors. In conclusion, 4-cycle neoadjuvant chemotherapy in combination with radiotherapy is expected to further control the distant metastasis rate of N2-3 nasopharyngeal carcinoma and improve the survival rate.

Conditions

• Nasopharyngeal Carcinoma
• Neoadjuvant Chemotherapy

Interventions

Type	Name	Description
DRUG	4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy	4 Cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy, instead of Concurrent Chemoradiotherapy
DRUG	3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy	3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy, instead of definitive radiotherapy

Timeline

• Start date: 2019-08-01
• Primary completion: 2022-06-30
• Completion: 2022-12-31
• First posted: 2019-08-19
• Last updated: 2020-05-12

Locations

12 sites across 1 country: China