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

Soochow University

Status and phase: Completed; Phase 2

Conditions: Rectum Cancer

Treatments: Procedure: Computed tomography guided radioactive seeds implant; Drug: Systemic chemotherapy (FOLFIRI)

Study type: Interventional

Funder types: Other

Identifiers

NCT02423226

CZ-I125-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

56 participants in 2 patient groups

CT alone

Active Comparator group

Description:

Treated with systemic chemotherapy alone (FOLFIRI).

Treatment:

Drug: Systemic chemotherapy (FOLFIRI)

CT+BT

Experimental group

Description:

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

Treatment:

Drug: Systemic chemotherapy (FOLFIRI)

Procedure: Computed tomography guided radioactive seeds implant