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

This study has been withdrawn prior to enrollment.
(No surgeon available to perfrom gastroscopy)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00960427
First received: August 14, 2009
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Colorectal Cancer Stem Cells Marker Expression in Rectal Cancer Patients Undergoing Chemoradiotherapy-A Pilot Study

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Estimation of stem cell markers with stated precision [ Designated as safety issue: No ]
  • Correlation of disease-free survival with post-treatment value and change in expression of colorectal cancer stem cell markers after neoadjuvant chemoradiotherapy [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960427

Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Bhaumik B. Patel, MD Barbara Ann Karmanos Cancer Institute
  More Information

No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00960427     History of Changes
Other Study ID Numbers: CDR0000649658, WSU-2009-041
Study First Received: August 14, 2009
Last Updated: April 12, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 18, 2014