Biomarkers in Patients With Rectal Cancer Undergoing Chemotherapy and Radiation Therapy

CompletedOBSERVATIONAL
Enrollment

47

Participants

Timeline

Start Date

December 31, 2003

Primary Completion Date

September 19, 2021

Study Completion Date

September 19, 2021

Conditions
Colorectal Cancer
Interventions
DRUG

capecitabine

Capecitabine administration (where deemed appropriate by the treating medical oncologist) will commence on the second day of radiotherapy after the 24-hour biopsy has been performed. Dosing will be per current standard of care at the discretion of the treating Medical, Radiation and Surgical Oncologist

DRUG

5-fluorouracil

Administration of 5-fluorouracil (where deemed appropriate by the treating medical oncologist) will commence on the second day of radiotherapy after the 24-hour biopsy has been performed. Dosing and dose modification will be per current standard of care at the discretion of the treating Medical, Radiation and Surgical Oncologist.

PROCEDURE

Surgical Resection

Surgery will occur approximately 2-6 weeks after chemoradiation depending on clinical factors (i.e. resectability, presence or absence of metastatic disease).

RADIATION

Radiation therapy

Dosing and dose modification will be per current standard of care at the discretion of the treating Radiation Oncologist.

Trial Locations (1)

27599-7295

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

UNC Lineberger Comprehensive Cancer Center

OTHER

NCT00280761 - Biomarkers in Patients With Rectal Cancer Undergoing Chemotherapy and Radiation Therapy | Biotech Hunter | Biotech Hunter