Neurological Effects of Chemotherapy and Radiation Therapy in Patients With Colon Cancer
This study has been completed.
Sponsor:
University of Arizona
Collaborator:
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT00410618
First received: December 11, 2006
Last updated: August 13, 2012
Last verified: August 2012
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Purpose
RATIONALE: Learning about the long-term effects of chemotherapy and radiation therapy on brain function may help doctors plan cancer treatments.
PURPOSE: This clinical trial is looking at the neurological effects of chemotherapy and radiation therapy in patients with colon cancer.
| Condition | Intervention |
|---|---|
|
Cognitive/Functional Effects Colorectal Cancer Long-term Effects Secondary to Cancer Therapy in Adults |
Procedure: cognitive assessment Procedure: magnetic resonance imaging Procedure: management of therapy complications |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Neurological Effects of Chemotherapy and Radiation Treatment: Colon Cancer |
Resource links provided by NLM:
Further study details as provided by University of Arizona:
Primary Outcome Measures:
- Nature and long-term ramifications of CNS injury as a result of cancer treatment
Secondary Outcome Measures:
- Differences in cognitive measures and MRI data
- Relationship between MRI measures and cognitive performance
| Estimated Enrollment: | 42 |
| Study Start Date: | April 2003 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Identify the nature and long-term ramifications of CNS injury as a result of cancer treatment in patients with colon cancer.
Secondary
- Analyze differences in cognitive measures and MRI data in these patients.
- Correlate MRI measures with cognitive performance in these patients.
OUTLINE: Patients undergo cognitive performance assessment and MRI.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Colon cancer
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of colon cancer
- Received chemotherapy and radiotherapy for colon cancer
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00410618
Locations
| United States, Arizona | |
| Arizona Cancer Center at University of Arizona Health Sciences Center | |
| Tucson, Arizona, United States, 85724-5024 | |
Sponsors and Collaborators
University of Arizona
Investigators
| Study Chair: | Sheryl Reminger, MD | University of Arizona |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Arizona |
| ClinicalTrials.gov Identifier: | NCT00410618 History of Changes |
| Other Study ID Numbers: | HSCB0213, P50CA095060, P30CA023074, UARIZ-BSC-02-13 |
| Study First Received: | December 11, 2006 |
| Last Updated: | August 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Arizona:
|
cognitive/functional effects long-term effects secondary to cancer therapy in adults recurrent colon cancer stage I colon cancer |
stage II colon cancer stage III colon cancer stage IV colon cancer |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013