NCT02423226

Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer

Phase II Study of Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: The First People's Hospital of Changzhou · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of CT guided 125I seeds implant plus systemic chemotherapy for locally recurrent rectum cancer.

Detailed description

The primary aim of this study is to determined the safety and efficacy of CT guided 125I seeds implant plus systemic chemotherapy for locally recurrent rectum cancer.The patients with recurrence in pelvic or on pelvic wall after rectal resection were treated with 125I seeds implant plus chemotherapy or chemotherapy alone. The side-effect, tumor response and survival data were recorded.

Conditions

• Rectum Cancer

Interventions

Type	Name	Description
PROCEDURE	Computed tomography guided radioactive seeds implant	Computed tomography guided radioactive seeds implant were performed one week before chemotherapy.
DRUG	Systemic chemotherapy (FOLFIRI)	irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks

Timeline

• Start date: 2008-10-01
• Primary completion: 2014-12-01
• Completion: 2015-04-01
• First posted: 2015-04-22
• Last updated: 2015-04-22