Back to resultsComputed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer
Primary Purpose
Rectum Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Computed tomography guided radioactive seeds implant
Systemic chemotherapy (FOLFIRI)
Sponsored by
About this trial
This is an interventional treatment trial for Rectum Cancer
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CT alone
CT+BT
Arm Description
Treated with systemic chemotherapy alone (FOLFIRI).
Treated with systemic chemotherapy (FOLFIRI) plus computed tomography guided radioactive seeds implant.
Outcomes
Primary Outcome Measures
Progression free survival
Progression free survival which is calculated from the start of treatment to disease progression or death
Secondary Outcome Measures
Treatment related adverse events
Including chemotherapy related side-effect and brachytherapy related adverse events.
Full Information
NCT ID
NCT02423226
First Posted
April 16, 2015
Last Updated
April 21, 2015
Sponsor
The First People's Hospital of Changzhou
1. Study Identification
Unique Protocol Identification Number
NCT02423226
Brief Title
Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer
Official Title
Phase II Study of Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First People's Hospital of Changzhou
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectum Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT alone
Arm Type
Active Comparator
Arm Description
Treated with systemic chemotherapy alone (FOLFIRI).
Arm Title
CT+BT
Arm Type
Experimental
Arm Description
Treated with systemic chemotherapy (FOLFIRI) plus computed tomography guided radioactive seeds implant.
Intervention Type
Procedure
Intervention Name(s)
Computed tomography guided radioactive seeds implant
Other Intervention Name(s)
Brachytherapy
Intervention Description
Computed tomography guided radioactive seeds implant were performed one week before chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Systemic chemotherapy (FOLFIRI)
Other Intervention Name(s)
FOLFIRI
Intervention Description
irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks
Primary Outcome Measure Information:
Title
Progression free survival
Description
Progression free survival which is calculated from the start of treatment to disease progression or death
Time Frame
One year
Secondary Outcome Measure Information:
Title
Treatment related adverse events
Description
Including chemotherapy related side-effect and brachytherapy related adverse events.
Time Frame
Eight weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changping Wu, M.D.
Organizational Affiliation
The First People's Hospital of Changzhou
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer
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