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Colorectal Cancer Stem Cells Marker Expression in Rectal Cancer Patients Undergoing Chemoradiotherapy-A Pilot Study

Phase 1
18 Years
80 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Colorectal Cancer Stem Cells Marker Expression in Rectal Cancer Patients Undergoing Chemoradiotherapy-A Pilot Study



- 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.


- 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.

Inclusion Criteria


- 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

- Stage III (any T, N1-2, M0) disease

- Tumor has invaded to any depth with involvement of regional lymph nodes

- Resectable disease

- No suspicious metastatic disease (M1)


- 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


- No prior radiotherapy or chemotherapy for rectal cancer

- No concurrent warfarin unless appropriate bridging therapy is arranged during biopsy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Estimation of stem cell markers with stated precision

Safety Issue:


Principal Investigator

Bhaumik B. Patel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




Start Date:

June 2009

Completion Date:

April 2010

Related Keywords:

  • Colorectal Cancer
  • adenocarcinoma of the rectum
  • stage II rectal cancer
  • stage III rectal cancer
  • Rectal Neoplasms
  • Colorectal Neoplasms