Trial | NCT02423226  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    56
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.
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 Started
Oct 31
2008
Primary Completion
Dec 31
2014
Study Completion
Apr 30
2015
Last Update
Apr 22
2015
Estimate

Procedure Computed tomography guided radioactive seeds implant

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

  • Other names: Brachytherapy

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

  • Other names: FOLFIRI

CT alone Active Comparator

Treated with systemic chemotherapy alone (FOLFIRI).

CT+BT Experimental

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

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
No Results Posted