Biomarkers in Patients With Rectal Cancer Undergoing Chemotherapy and Radiation Therapy

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Studying samples of tumor tissue 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 understand how patients respond to treatment.

PURPOSE: This clinical trial is studying biomarkers in patients with rectal cancer undergoing chemotherapy and radiation therapy.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine; Fluorouracil

Criteria

DISEASE CHARACTERISTICS:

• Must have rectal or sigmoid-rectal junction adenocarcinoma confirmed by sigmoidoscopy and pathologic diagnosis of biopsy sample

• Inferior margin of the tumor less than 15 cm from anal verge by rigid sigmoidoscopy or below the level of S1-2 at surgery

• Candidate for chemotherapy and radiotherapy, as defined by any of the following:

• Tumor staged as T3 or N1-2 by rectal sonography

• Tumor occupying > 40% of circumference of rectum

• Tumor fixed to extra colonic structures as determined by digital rectal examination

• Tumor < 5 cm from sphincter mechanism

• Patient has inoperable disease and is being treated for palliation

• Pelvic or anastomotic recurrences of previously resected rectal cancer

• Planning to undergo chemotherapy and radiotherapy

• No sigmoid carcinoma (carcinoma proximal to the pelvic peritoneal reflection)

PATIENT CHARACTERISTICS:

• Not pregnant

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics