Back to resultsStudying 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
Primary Purpose
Colorectal Cancer
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
systemic chemotherapy
RNA analysis
gene expression analysis
reverse transcriptase-polymerase chain reaction
immunohistochemistry staining method
laboratory biomarker analysis
endoscopic biopsy
neoadjuvant therapy
sigmoidoscopy
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the rectum, stage II rectal cancer, stage III rectal cancer
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00960427
First Posted
August 14, 2009
Last Updated
April 12, 2013
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00960427
Brief Title
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
Official Title
Colorectal Cancer Stem Cells Marker Expression in Rectal Cancer Patients Undergoing Chemoradiotherapy-A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Withdrawn
Why Stopped
No surgeon available to perfrom gastroscopy
Study Start Date
June 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
adenocarcinoma of the rectum, stage II rectal cancer, stage III rectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
systemic chemotherapy
Intervention Type
Genetic
Intervention Name(s)
RNA analysis
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
reverse transcriptase-polymerase chain reaction
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Procedure
Intervention Name(s)
endoscopic biopsy
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
sigmoidoscopy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Estimation of stem cell markers with stated precision
Title
Correlation of disease-free survival with post-treatment value and change in expression of colorectal cancer stem cell markers after neoadjuvant chemoradiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bhaumik B. Patel, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
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
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