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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00960427
Recruitment Status : Withdrawn (No surgeon available to perfrom gastroscopy)
First Posted : August 17, 2009
Last Update Posted : April 16, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: systemic chemotherapy Genetic: RNA analysis Genetic: gene expression analysis Genetic: reverse transcriptase-polymerase chain reaction Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: endoscopic biopsy Procedure: neoadjuvant therapy Procedure: sigmoidoscopy Radiation: radiation therapy Phase 1

Detailed Description:



  • 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.


  • 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 : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Colorectal Cancer Stem Cells Marker Expression in Rectal Cancer Patients Undergoing Chemoradiotherapy-A Pilot Study
Study Start Date : June 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Estimation of stem cell markers with stated precision
  2. Correlation of disease-free survival with post-treatment value and change in expression of colorectal cancer stem cell markers after neoadjuvant chemoradiotherapy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)


  • 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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00960427

Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Bhaumik B. Patel, MD Barbara Ann Karmanos Cancer Institute

Responsible Party: Barbara Ann Karmanos Cancer Institute Identifier: NCT00960427     History of Changes
Other Study ID Numbers: CDR0000649658
WSU-2009-041 ( Other Identifier: Wayne State University - Human Investigation Committee )
First Posted: August 17, 2009    Key Record Dates
Last Update Posted: April 16, 2013
Last Verified: April 2013

Keywords provided by Barbara Ann Karmanos Cancer Institute:
adenocarcinoma of the rectum
stage II rectal cancer
stage III rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases