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Tumor Replication Error (RER) Status and Outcome in a Colon Cancer Adjuvant Chemotherapy Trial


N/A
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N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Tumor Replication Error (RER) Status and Outcome in a Colon Cancer Adjuvant Chemotherapy Trial


OBJECTIVES:

- Determine the relationship between disease free survival, overall survival, and tumor
replication error status for patients who have received adjuvant chemotherapy for colon
cancer on CALGB protocol 8896.

- Determine the prognostic and predictive values for response to this therapy in these
patients.

OUTLINE: Samples of tumor and normal tissue are obtained from CALGB 8896 patients. The
samples are tested for somatic mutations and tumor replication error (RER) tumor status.

Patients do not receive the results of the genetic testing and the results do not influence
the type or duration of treatment.

PROJECTED ACCRUAL: At least 300 specimens will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Patients who received chemotherapy for colon cancer as part of CALGB protocol 8896

- Underwent an initial resection for adenocarcinoma of the colon and were determined to
have a high risk of tumor recurrence based upon nodal disease or local extension of
tumor with obstruction or perforation due to tumor

- Surgical specimen blocks available, including tumor tissue and normal tissue

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- See Disease Characteristics

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Monica M. Bertagnolli, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber/Brigham and Women's Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066637

NCT ID:

NCT00003571

Start Date:

August 1998

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage III colon cancer
  • adenocarcinoma of the colon
  • Colonic Neoplasms
  • Colorectal Neoplasms

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Rhode Island Hospital Providence, Rhode Island  02903
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
University of California San Diego Cancer Center La Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
New York Presbyterian Hospital - Cornell Campus New York, New York  10021
Holden Comprehensive Cancer Center at The University of Iowa Iowa City, Iowa  52242-1009
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Lombardi Cancer Center Washington, District of Columbia  20007
Veterans Affairs Medical Center - Birmingham Birmingham, Alabama  35233
Veterans Affairs Medical Center - White River Junction White River Junction, Vermont  05009
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Memphis Memphis, Tennessee  38104
Veterans Affairs Medical Center - Richmond Richmond, Virginia  23249
Veterans Affairs Medical Center - Togus Togus, Maine  04330
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705
Schneider Children's Hospital at North Shore Manhasset, New York  11030