Studying Biomarkers in Tumor Tissue and Blood Samples From Patients Undergoing Chemotherapy and Radiation Therapy for Stage II or Stage III Rectal Cancer That Can Be Removed By Surgery

April 12, 2013 updated by: Barbara Ann Karmanos Cancer Institute

Colorectal Cancer Stem Cells Marker Expression in Rectal Cancer Patients Undergoing Chemoradiotherapy-A Pilot Study

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.

PURPOSE: This phase I trial is studying biomarkers in tumor tissue and blood samples from patients undergoing chemotherapy and radiation therapy for stage II or stage III rectal cancer that can be removed by surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

OBJECTIVES:

Primary

  • To obtain the distribution of stem cell markers (CD166, CD44, and ESA) in tumor tissue samples before and after neoadjuvant chemoradiotherapy (NCRT) in patients with stage II or III rectal cancer.

Secondary

  • To correlate disease-free survival after NCRT with baseline expression and change in expression of stem cell markers (CD166, CD44, and ESA) after NCRT.
  • To correlate baseline and post-NCRT expression of all three stem cell markers (CD166, CD44, and ESA) with circulating tumor cell (CTC) count and stem cell marker expression on CTC at baseline and after NCRT.

OUTLINE: Patients receive chemotherapy according to the treating physician's choice and undergo concurrent radiotherapy over approximately 6 weeks. Between 6-8 weeks after completion of neoadjuvant chemoradiotherapy (NCRT), patients undergo low anterior or abdominoperineal surgical resection. Some patients may then receive additional chemotherapy.

Tumor tissue samples are obtained via sigmoidoscopy-guided biopsies at baseline and at the time of surgery. Blood samples are also collected at baseline and after completion of NCRT. Samples are isolated for RNA analysis of CD44, CD166, and ESA expression by quantitative reverse transcriptase-PCR and IHC.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the rectum

    • Inferior margin within 16 cm of the anal verge on endoscopic exams

  • Locally advanced or low lying disease meeting 1 of the following stage criteria:

    • Stage II (T2, N0, M0) disease

      • Distal tumor (< 5 cm from anal verge) invades into muscularis propria but not beyond (T2)

    • Stage II (T3-4, N0, M0) disease

      • Tumor invades through muscularis propria into subserosa or into non-peritonealized pericolic or perirectal tissues (T3) OR tumor directly invades other organs or structures and/or perforates visceral peritoneum (T4)

    • Stage III (any T, N1-2, M0) disease

      • Tumor has invaded to any depth with involvement of regional lymph nodes (N1-2)
  • Resectable disease
  • No suspicious metastatic disease (M1)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Adequate organ function

  • No significant co-morbidities that would preclude the use of neoadjuvant chemoradiotherapy, including any of the following:

    • Severe heart failure
    • Arrhythmia
    • Significant liver or kidney dysfunction
  • No psychiatric or addictive disorder that would preclude study compliance
  • No bleeding diathesis
  • No contraindication for sigmoidoscopy

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy or chemotherapy for rectal cancer
  • No concurrent warfarin unless appropriate bridging therapy is arranged during biopsy procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Estimation of stem cell markers with stated precision
Correlation of disease-free survival with post-treatment value and change in expression of colorectal cancer stem cell markers after neoadjuvant chemoradiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Barbara Ann Karmanos Cancer Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bhaumik B. Patel, MD, Barbara Ann Karmanos Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CDR0000649658
  • WSU-2009-041 (Other Identifier: Wayne State University - Human Investigation Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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