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
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: systemic chemotherapy|nan|
|Genetic: RNA analysis|nan|
|Genetic: gene expression analysis|nan|
|Genetic: reverse transcriptase-polymerase chain reaction|nan|
|Other: immunohistochemistry staining method|nan|
|Other: laboratory biomarker analysis|nan|
|Procedure: endoscopic biopsy|nan|
|Procedure: neoadjuvant therapy|nan|
|Procedure: sigmoidoscopy|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the rectum, stage II rectal cancer, stage III rectal cancer