NCT03393234

Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer

Study of Safety and Feasibility of the Intersphincteric Resection With or Without Intraoperative Radiation in Low Rectal Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Second Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer.

Detailed description

Inter-sphincteric resection (ISR) has become an increasingly popular optional surgical tool for the treatment of very low rectal cancer. Nowadays, preoperative criteria for Lap ISR were the patients whose diagnosed with clinical stages T1-2 and N0\_1, which only a few patients with early stages can benefit from it. However, intra-operative radiotherapy with low energy X ray applied by Intrabeam is becoming an accepted radiotherapy technique for treatment of cancers. The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Interoperative radiation by INTRABEAM using low energy X-ray	Intrabeam is a mobile Platform for Intraoperative Radiotherapy (IORT) produced by the ZEISS company in Germany.Interoperative radiation by INTRABEAM using low energy X-ray.The Intrabeam PRS appears to be a safe technique for delivering IORT in rectal cancer patients.

Timeline

• Start date: 2017-06-01
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2018-01-08
• Last updated: 2018-01-08

Locations

1 site across 1 country: China