NCT02132858

Genetic Mutations in Blood and Tissue Samples in Predicting Response to Treatment in Patients With Locally Advanced Rectal Cancer Undergoing Chemoradiation

Assessing Intratumoral Heterogeneity and Chemoradiation Response in Locally Advanced Rectal Cancer Utilizing Sequencing and PET/CT

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research trial studies genetic mutations in blood and tissue samples to see if they can be used to predict treatment response in patients with locally advanced rectal cancer undergoing chemoradiation. Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about genetic mutations or changes that occur in deoxyribonucleic acid (DNA) and help doctors understand how patients respond to treatment.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the tumor-specific mutation(s) detected using the CancerCode™ mutation panel as a predictor of pathologic response to chemoradiation for patients with rectal adenocarcinoma undergoing chemoradiation. SECONDARY OBJECTIVES: I. To assess the feasibility of utilizing biopsy specimens from locally advanced rectal adenocarcinoma to perform CancerCode™ mutation panel genetic testing. II. To assess disease-free survival (DFS) and overall survival (OS) of patients treated on study. III. To collect pilot data regarding the clonal heterogeneity of rectal adenocarcinoma, and the relationship of this heterogeneity with treatment response. IV. To evaluate the treatment response utilizing multiple fludeoxyglucose F 18-positron emission tomography (FDG-PET) parameters including heterogeneity and textural features as an exploratory study. OUTLINE: Patients undergo collection of blood and tissue samples for analysis via sequencing. After completion of study, patients are followed up every 3 months for 3 years.

Conditions

• Mucinous Adenocarcinoma of the Rectum
• Recurrent Rectal Cancer
• Signet Ring Adenocarcinoma of the Rectum
• Stage IIA Rectal Cancer
• Stage IIB Rectal Cancer
• Stage IIC Rectal Cancer
• Stage IIIA Rectal Cancer
• Stage IIIB Rectal Cancer
• Stage IIIC Rectal Cancer

Interventions

Type	Name	Description
OTHER	cytology specimen collection procedure	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2014-07-01
• Primary completion: 2022-04-08
• Completion: 2022-10-01
• First posted: 2014-05-07
• Last updated: 2024-05-02

Locations

1 site across 1 country: United States