NCT02562599

Chemoradiotherapy for Patients With Locally Advanced Nasopharyngeal Carcinoma Using Raltitrexed-Cisplatin

Study Of Induction Chemotherapy Followed by Concurrent Chemoradiotherapy With Raltitrexed-Cisplatin for Patients With Locally Advanced Nasopharyngeal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Hubei Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of raltitrexed and cisplatin neoadjuvant chemotherapy followed by concurrent radiotherapy with raltitrexed and cisplatin in patients with locally advanced nasopharyngeal carcinoma.

Detailed description

Although concurrent chemoradiation is the standard treatment modality for locally advanced nasopharyngeal carcinoma (NPC), high incidences of distant metastases and severe treatment related toxicities have become an obstacle to be overcome. A phase Ⅱ study conducted by Hui et al. showed that neoadjuvant chemotherapy followed by concurrent chemoradiotherapy was superior to the standard concomitant chemoradiation in terms of the 3-year OS without significantly exacerbating the acute toxicities. At present, PF regimen has been considered as the most classic chemotherapy regimen of nasopharyngeal carcinoma (NPC), but its efficiency is about 40%-60% , and always with severe gastrointestinal reactions, renal toxicity and oral mucosa reaction. Therefore, it is imperative to find a more safe and effective chemotherapy regimen. Raltitrexed is a specific thymidylate synthase inhibitor with a convenient administration schedule,acceptable and manageable toxicity, radiosensitising properties. It may offer advantages compared with standard 5-FU chemotherapy regimens used in locally advanced NPC. Therefore, the investigators initiated this study to evaluate the efficacy and safety of raltitrexed and cisplatin neoadjuvant chemotherapy followed by concurrent radiotherapy with raltitrexed and cisplatin in patients with locally advanced NPC.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	raltitrexed-cisplatin	Patients receive raltitrexed-cisplatin neoadjuvant chemotherapy every three weeks for two cycles, then receive raltitrexed -cisplatin concurrent chemoradiotherapy every three weeks for two cycles
RADIATION	Intensity-modulated radiotherapy (IMRT)	Patients receive raltitrexed -cisplatin concurrent chemoradiotherapy every three weeks for two cycles

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-12-01
• Completion: 2018-08-01
• First posted: 2015-09-29
• Last updated: 2022-02-22

Locations

1 site across 1 country: China