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

NCT00960427 | Withdrawn Phase 1 DMC

• 2 other identifiers: CDR0000649658WSU-2009-041
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the rectum; stage II rectal cancer; stage III rectal cancer

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

systemic chemotherapy DRUG

RNA analysis GENETIC

gene expression analysis GENETIC

reverse transcriptase-polymerase chain reaction GENETIC

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

endoscopic biopsy PROCEDURE

neoadjuvant therapy PROCEDURE

sigmoidoscopy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Interventions

Neoadjuvant Therapy; Gene Expression Profiling; Reverse Transcriptase Polymerase Chain Reaction; Immunohistochemistry; Endoscopic Mucosal Resection; Sigmoidoscopy; Radiotherapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Genetic Techniques; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Colonoscopy

Study Officials

• Bhaumik B. Patel, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: August 17, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 16, 2013

Record last verified: 2013-04