NCT00410618

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2006

Completed
Last Updated

July 6, 2018

Status Verified

August 1, 2012

Enrollment Period

3.3 years

First QC Date

December 11, 2006

Last Update Submit

July 3, 2018

Conditions

Cognitive/Functional EffectsColorectal CancerLong-term Effects Secondary to Cancer Therapy in Adults

Keywords

cognitive/functional effectslong-term effects secondary to cancer therapy in adultsrecurrent colon cancerstage I colon cancerstage II colon cancerstage III colon cancerstage IV colon cancer

Outcome Measures

Primary Outcomes (1)

  • Nature and long-term ramifications of CNS injury as a result of cancer treatment

Secondary Outcomes (2)

  • Differences in cognitive measures and MRI data

  • Relationship between MRI measures and cognitive performance

Interventions

cognitive assessmentPROCEDURE
magnetic resonance imagingPROCEDURE
management of therapy complicationsPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Colon cancer

DISEASE CHARACTERISTICS: * Diagnosis of colon cancer * Received chemotherapy and radiotherapy for colon cancer PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724-5024, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Interventions

Mental Status and Dementia TestsMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and ActivitiesSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Sheryl Reminger, MD

    University of Arizona

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2006

First Posted

December 13, 2006

Study Start

April 1, 2003

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

July 6, 2018

Record last verified: 2012-08

Locations

US(1)