Status:
WITHDRAWN
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
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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....
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 o...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00960427
Start Date
June 1 2009
End Date
April 1 2010
Last Update
April 16 2013
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