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

NCT ID: NCT02423226

Last Updated: 2015-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2015-04-30

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.

Conditions

Rectum Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CT alone

Treated with systemic chemotherapy alone (FOLFIRI).

Group Type: ACTIVE_COMPARATOR

Systemic chemotherapy (FOLFIRI)

Intervention Type: DRUG

irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks

CT+BT

Treated with systemic chemotherapy (FOLFIRI) plus computed tomography guided radioactive seeds implant.

Group Type: EXPERIMENTAL

Computed tomography guided radioactive seeds implant

Intervention Type: PROCEDURE

Computed tomography guided radioactive seeds implant were performed one week before chemotherapy.

Systemic chemotherapy (FOLFIRI)

Intervention Type: DRUG

irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks

Interventions

Computed tomography guided radioactive seeds implant

Computed tomography guided radioactive seeds implant were performed one week before chemotherapy.

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

Other Intervention Names

Brachytherapy; FOLFIRI

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First People's Hospital of Changzhou

OTHER

Sponsor Role: lead

Responsible Party

Liangrong Shi

Director of Science and Education Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Changping Wu, M.D.

Role: STUDY_DIRECTOR

The First People's Hospital of Changzhou

Other Identifiers

CZ-I125-001

Identifier Type: -

Identifier Source: org_study_id