Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer
April 21, 2015 updated by: Liangrong Shi, The First People's Hospital of Changzhou
Phase II Study of Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: CT alone
Treated with systemic chemotherapy alone (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:
|
|
Experimental: CT+BT
Treated with systemic chemotherapy (FOLFIRI) plus computed tomography guided radioactive seeds implant.
|
irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks
Other Names:
Computed tomography guided radioactive seeds implant were performed one week before chemotherapy.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression free survival
Time Frame: One year
|
Progression free survival which is calculated from the start of treatment to disease progression or death
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment related adverse events
Time Frame: Eight weeks
|
Including chemotherapy related side-effect and brachytherapy related adverse events.
|
Eight weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
April 16, 2015
First Submitted That Met QC Criteria
April 21, 2015
First Posted (Estimate)
April 22, 2015
Study Record Updates
Last Update Posted (Estimate)
April 22, 2015
Last Update Submitted That Met QC Criteria
April 21, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CZ-I125-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.