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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

12. april 2013 oppdatert av: Barbara Ann Karmanos Cancer Institute

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

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.

Studieoversikt

Status

Tilbaketrukket

Forhold

Tykktarmskreft

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Fase

Fase 1

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Barbara Ann Karmanos Cancer Institute

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

Hovedetterforsker: Bhaumik B. Patel, MD, Barbara Ann Karmanos Cancer Institute

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2009

Primær fullføring (Faktiske)

1. april 2010

Studiet fullført (Faktiske)

1. april 2010

Datoer for studieregistrering

Først innsendt

14. august 2009

Først innsendt som oppfylte QC-kriteriene