NCT02429622

Simultaneous Integrated Boost Radiotherapy and Concurrent Chemotherapy for Locally Advanced Esophageal Carcinoma

A Phase Ⅰ/Ⅱ Study of Simultaneous Integrated Boost Radiotherapy and Concurrent Chemotherapy in Patients With Locally Advanced Esophageal Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

This phase Ⅰ/Ⅱ trial is designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for locally advanced esophageal carcinoma.

Detailed description

Despite the application of IMRT and the studies of concurrent chemoradiation in esophageal carcinoma, which improves 5-year survival rate from 10% to 20%-40% and decrease recurrence rate from 80% to 50%-60%, local recurrence remains to be the most common failure pattern. Therefore, enhancing local control is the key to obtain a better survival. A phase Ⅱ study of radical radiotherapy with IMRT simultaneous integrated boost technique and concurrent chemotherapy for esophageal carcinoma use the same radiation dose as the high dose arm in RTOG 94-05, which reveals an significantly improved median survival time of 23 months and 3-year overall survival rate of 44.4%. This study implies the simultaneous integrated boost technique may be effective to some extent. But the question is how to identify patients who may gain potential benefits, and whether this therapeutic model can be copied in the specific situation in China? Few adverse effects such as perforation, hemorrhage and stenosis was reported, mainly owing to the lack of cases. For widely application of this new technique in the clinic, more studies need to be conducted in the future to obtain sufficient evidence. The current IMRT can simultaneously achieve prophylactic dose (DT 50Gy) and radical dose (DT 60-64Gy) in respective target volume by using inverse intensity-modulated planning system. However, it is still controversial on whether esophageal carcinoma can receive prescription dose more than 2.0Gy each time. That is to say, it is challengeable to find an optimal fraction dose and total dose between tumor and adverse effects. For this reason, the dose escalation trial is to be conducted to explore the clinical value and optimal dose to esophageal carcinoma with different radiosensitivity, and also provide data support for phase Ⅲ clinical trials.

Conditions

• Esophageal Neoplasms

Interventions

Type	Name	Description
RADIATION	IMRT simultaneous integrated boost	To achieve a prophylactic dosage and radical dosage once respectively
DRUG	Paclitaxel	Paclitaxel from 45 to 60 mg/m2 per week concurrent with radiotherapy for 5weeks
DRUG	Nedaplatin	Nedaplatin 25mg/m2 per week concurrent with radiotherapy for 5weeks
PROCEDURE	Esophagectomy	Radical esophagectomy 4-6 weeks after neoadjuvant therapy

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2015-04-29
• Last updated: 2017-01-18

Locations

1 site across 1 country: China