NCT02627807

Clinical Target Volume Based on Disease Extension Risk Atlas and Computer-aided Delineation in Nasopharyngeal Carcinoma

Prospective Non-inferiority Randomized Trial Comparing Clinical Target Volume Based on Disease Extension Risk Atlas and Computer-aided Delineation and Traditional Clinical Target Volume in Radiotherapy for Nasopharyngeal Carcinoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 386 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare individualized clinical target volume (CTV) based on disease extension risk atlas and computer-aided delineation with traditional CTV in intensity modulated radiotherapy (IMRT) for nasopharyngeal carcinoma (NPC), in order to confirm the efficacy and safety.

Detailed description

Patients with non-keratinizing NPC T1-4N0-3M0 (AJCC/UICC staging system 7th edition) are randomly assigned to receive IMRT using individualized clinical target volume (CTV) based on disease extension risk atlas and computer-aided delineation or IMRT using traditional CTV. IMRT is given as 2.13 Gray (Gy) per fraction with five daily fractions per week for 6-7 weeks to a total dose of 70.29 Gy to the primary tumor. Patients with T1N0M0 NPC receive IMRT only. For patients with stage T2-4N0-3M0 NPC, concurrent chemoradiotherapy (CCRT) is required and induction chemotherapy (IC) before CCRT is optional.Patients who participate in another randomized trial (NCT01872962) at the same time receive the protocol chemotherapy. Induction chemotherapy regimens are as follows: gemcitabine (1000 mg/m² d1,8) plus cisplatin (80mg/m² d1) or docetaxel (75mg/m² d1) plus cisplatin (75mg/m², total dose average to d1-d3) every 3 weeks for three cycles. concurrent chemotherapy include cisplatin (100mg/m² d1 or 80mg/m², total dose average to d1-d3) every 3 weeks for three cycles. Our primary endpoint is loco-regional recurrence-free survival (LRRFS) rate. Secondary end points include overall survival (OS) rate, distant metastasis-free survival (DMFS) rate, constituent ratio of local and regional recurrence pattern, toxic effects, quality of life scores and dosimetric parameters of IMRT planning. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Conditions

• Nasopharyngeal Neoplasms

Interventions

Type	Name	Description
RADIATION	IMRT using individualized CTV	Intensity modulated radiotherapy (IMRT) using individualized CTV based on disease extension risk atlas and computer-aided delineation is given as 2.13 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 70.29 Gy to the primary tumor.
RADIATION	IMRT using traditional CTV	Intensity modulated radiotherapy(IMRT) using traditional CTV is given as 2.13 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 70.29 Gy to the primary tumor.
DRUG	Gemcitabine and cisplatin (induction chemotherapy)	Induction chemotherapy is optional for patients with T2-4N0-3M0 NPC. Patients who participate in another randomized trial (NCT01872962) at the same time receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy.
DRUG	Docetaxel and cisplatin (induction chemotherapy)	Induction chemotherapy is optional for patients with T2-4N0-3M0 NPC. Patients who haven't participated in other trials receive docetaxel (75 mg/m² d1) and cisplatin (75mg/m²,total dose average to d1-d3) every 3 weeks for 3 cycles before radiotherapy.
DRUG	Cisplatin 100mg/m² concurrent chemotherapy	Cisplatin concurrent chemotherapy is required for patients with T2-4N0-3M0 NPC. Patients who participate another clinical trial (NCT01872962) at the same time receive cisplatin (100mg/m² d1) every 3 weeks for 3 cycles concurrently with radiotherapy.
DRUG	Cisplatin 80mg/m² concurrent chemotherapy	Cisplatin concurrent chemotherapy is required for patients with T2-4N0-3M0 NPC.Patients who haven't participated in other trials receive cisplatin (80mg/m²,total dose average to d1-d3) every 3 weeks for 3 cycles concurrently with radiotherapy.

Timeline

• Start date: 2015-12-01
• Primary completion: 2020-12-01
• Completion: 2022-12-01
• First posted: 2015-12-11
• Last updated: 2020-06-16

Locations

1 site across 1 country: China