Neurological Effects of Chemotherapy and Radiation Therap... | NCT00410618

ID	Type	Description	Link
P50CA095060	U.S. NIH Grant/Contract		View source
P30CA023074	U.S. NIH Grant/Contract		View source
UARIZ-BSC-02-13	Other Identifier	University of Arizona

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Aug 2006Actual

Completion Date

Aug 2006Actual

First Submitted Date

Dec 11, 2006

First Submission Date that Met QC Criteria

Dec 11, 2006

First Posted Date

Dec 13, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2018

Last Update Posted Date

Jul 6, 2018Actual

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Detailed Description

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.

Conditions Module

Conditions

Cognitive/Functional Effects
Colorectal Cancer
Long-term Effects Secondary to Cancer Therapy in Adults

Keywords

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nature and long-term ramifications of CNS injury as a result of cancer treatment

Secondary Outcomes

Measure	Description	Time Frame
Differences in cognitive measures and MRI data
Relationship between MRI measures and cognitive performance

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of colon cancer
Received chemotherapy and radiotherapy for colon cancer

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Colon cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sheryl Reminger, MD	University of Arizona	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Cancer Center at University of Arizona Health Sciences Center		Tucson	Arizona	85724-5024	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

Name	Type	Description	Arm Group Labels	Other Names
cognitive assessment	Procedure
magnetic resonance imaging	Procedure
management of therapy complications	Procedure

ID	Term
D000073216	Mental Status and Dementia Tests
D009682	Magnetic Resonance Spectroscopy

ID	Term
D009483	Neuropsychological Tests
D011581	Psychological Tests
D004191	Behavioral Disciplines and Activities
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques