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Prognostic Molecular and Environmental Factors in High-Risk Stage II and Stage III Colon Cancer Patients

14 Years
Open (Enrolling)
Colon Cancer

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Trial Information

Prognostic Molecular and Environmental Factors in High-Risk Stage II and Stage III Colon Cancer Patients

Treatment with drugs (chemotherapy) and frequent evaluations by a doctor are standard
practice to help prevent colon cancer from recurring after surgery. Despite these measures,
the cancer does recur in a significant number of people, usually within the first 2-3 years
from diagnosis.

In this study, researchers hope to identify genetic and environmental factors that may
contribute to a person developing recurrent colon cancer. To help identify these factors,
blood and tissue samples will be studied. You also will be asked to provide information
about your background, lifestyle, and eating habits.

Participants able to take part in this study have had all of their known colon cancer
removed by surgery and have agreed to receive chemotherapy to help prevent the cancer from
recurring. Before you take part in this study, your medical information will be reviewed,
and a performance status evaluation (how well you perform everyday activities) will be done.
This will help the doctor decide if you are eligible to take part in the study.

If you are found to be eligible and you agree to take part in the study, you will be asked
to fill out 2 questionnaires. One questionnaire asks about your background (age, education,
etc.), work history, any exposure to toxic substances, medical history, smoking and alcohol
history, family history of cancer, and your level of physical activity. The second
questionnaire contains questions about what types of foods you eat, how often you eat them,
whether you take vitamins and if so, what type(s). It will take about 30 minutes to fill out
both of these questionnaires.

If your surgery to remove your colon cancer was not performed at MD Anderson, you will not
be asked to participate in the tissue portion of this study described below but you will be
asked to participate in the blood sample analysis and the study evaluations and
questionnaire portion of this study every 3 months for a maximum of 2 years (starting from
the beginning of the follow-up period, once all treatment is complete) or until your disease
returns, which ever occurs first.

If your surgery was performed at MD Anderson Cancer Center, the samples of your cancer
tissue will be analyzed, looking for any biologic factors related to colon cancer. Blood
samples (about 4 teaspoons) for gene analysis (looking for any biologic factors associated
with colon cancer) will also be collected.

Once follow-up begins, you will have study evaluations at MD Anderson every 3 months for 2
years or until your disease returns, which ever occurs first. Blood samples (about 4
teaspoons) for gene analysis will be collected within 14 days of completion of chemotherapy,
and then every 3 months for 2 years after you enroll in this study. If your colon cancer
recurs, a blood sample will be taken at that time also.

You will be asked to fill out the 2 questionnaires described above at the completion of
your chemotherapy treatment (if applicable) and 1 and 2 years after your follow-up begins.
If your colon cancer recurs, you will be asked to fill out the questionnaires at that time.

If you require surgery for cancer after enrolling in this study, a sample of leftover tissue
will be collected for genetic analysis if the surgery is performed at MD Anderson Cancer

You will not be informed of any results of the analysis of your blood and tumor samples or
the questionnaires, as this research is exploratory. Your participation in this study will
end if your disease returns or 2 years after you begin, whichever occurs first.

This is an investigational study. Up to 200 participants will take part in this study. All
will be enrolled at MD Anderson.

Inclusion Criteria:

1. Histologically proven adenocarcinoma of the colon. Those patients that do not have
tissue available at MDACC for analysis will be eligible to participate in the blood,
questionnaire and data portion of the study. They will not participate in the tissue
portion of this study.

2. AJCC stage II [T3-4(subscript)N0(subscript)M0(subscript)]or stage III

3. Age >= 14 yrs old.

4. All patients who participate in this study must agree to receive adjuvant
chemotherapy. If the chemotherapy is to be administered outside M. D. Anderson Cancer
Center, the patient must agree to complete all subsequent surveillance at M.D.
Anderson Cancer Center if participating in this clinical trial.

5. Ability to understand and the willingness to sign the written informed
consent/authorization document.

Exclusion Criteria:

1. Patients who have initiated adjuvant chemotherapy prior to participating in this
study will not be included.

2. Patients with known history of familial adenomatous polyposis (FAP), hereditary
nonpolyposis colorectal cancer (HNPCC), and any other hereditary polyposis syndrome
(Muir Torre, Gardner's Syndrome, etc) will be excluded since these patients are at
increased risk for second primary malignancies and are at higher risk of recurrent

3. No prior malignancies (excluding non-melanomatous skin neoplasms) over the past 5

4. Patients with a known diagnosis of HIV/AIDS or Hepatitis C will be excluded from this
study due to their increased risk of second primary malignancies that may complicate
appropriate analysis of DFS.

5. Patients who are unable to self-administer the protocol questionnaire will be
excluded from this study.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Occurence of Recurrent Colon Cancer

Outcome Time Frame:

Information collected at 1, 2 and 3 years after completion of adjuvant chemotherapy or at the time of reoccurrence.

Safety Issue:


Principal Investigator

Cathy Eng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2006

Completion Date:

Related Keywords:

  • Colon Cancer
  • Colon Cancer
  • Adenocarcinoma of the Colon
  • Cancer Recurrence
  • Survey
  • Chemotherapy
  • Surgery
  • Colonic Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030