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)

Study 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.

Read the 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.

Conditions studied

Colorectal Cancer

Browse trials for

Keywords

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

In context

Colorectal Neoplasms

5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

Browse Colorectal Neoplasms studies →

Lead sponsor

Barbara Ann Karmanos Cancer Institute is the lead sponsor of 158 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
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

Study design

Phase: Phase 1
Primary purpose: Treatment
Masking: None (open label)
Enrollment: 0 participants (actual)

Interventions

Drugsystemic chemotherapy
GeneticRNA analysis
Geneticgene expression analysis
Geneticreverse transcriptase-polymerase chain reaction
Otherimmunohistochemistry staining method
Otherlaboratory biomarker analysis
Procedureendoscopic biopsy
Procedureneoadjuvant therapy
Proceduresigmoidoscopy
Radiationradiation therapy

What researchers measure

Primary outcomes

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

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00960427
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Aug 17, 2009
Start date: Jun 2009
Primary completion: Apr 2010
Completion: Apr 2010
Last update: Apr 16, 2013

Study contacts

Bhaumik B. Patel, MD

principal investigator · Barbara Ann Karmanos Cancer Institute

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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