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

Phase 2

Completed

• Conditions: Rectum Cancer
• Interventions: Drug: Systemic chemotherapy (FOLFIRI); Procedure: Computed tomography guided radioactive seeds implant

• Registration Number: NCT02423226
• Lead Sponsor: The First People's Hospital of Changzhou

Brief 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.

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2014-12
• Status Verified: 2015-04
• Study Completion: 2015-04
• Study First Submitted: 2015-04-16
• Study First Submitted QC: 2015-04-21
• Last Update Submitted: 2015-04-21
• Study First Posted: 2015-04-22
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Limited locoregional recurrence including solitary recurrence at primary tumor bed, solitary intraabdominal peritoneal recurrence, and single regional lymph node recurrence (no more than 3 lymph nodes) based on diagnosis by CT, and confirmed by percutaneous puncture biopsy
• Second-line treatment for advanced colorectal cancer,irinotecan was not previously used.
• Age range 18-70 years old
• ECOG performance status 0-1
• Life expectancy of more than 3 months
• Adequate organ function

Read More

Exclusion Criteria

Previous serious cardiac disease

• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Pregnant or lactating women
• Chronic inflammatory bowel disease or intestinal obstruction
• Serious uncontrolled diseases and intercurrent infection

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT alone	Systemic chemotherapy (FOLFIRI)	Treated with systemic chemotherapy alone (FOLFIRI).
CT+BT	Computed tomography guided radioactive seeds implant	Treated with systemic chemotherapy (FOLFIRI) plus computed tomography guided radioactive seeds implant.
CT+BT	Systemic chemotherapy (FOLFIRI)	Treated with systemic chemotherapy (FOLFIRI) plus computed tomography guided radioactive seeds implant.

Primary Outcome Measures

Name	Time	Method
Progression free survival	One year	Progression free survival which is calculated from the start of treatment to disease progression or death

Secondary Outcome Measures

Name	Time	Method
Treatment related adverse events	Eight weeks	Including chemotherapy related side-effect and brachytherapy related adverse events.