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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief 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 Summary:

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.


Sponsor: Fox Chase Cancer Center

Current Primary Outcome:

  • Proportion of the randomly chosen samples that are successfully sequenced [ Time Frame: Up to 3 years ]
    If >= 90% of the specimens (at least 72 out of 80) are useable, the method will be considered feasible.
  • Tumor response measured using the tumor regression grading system [ Time Frame: Up to 3 years ]
    Whether mutations in any gene on the CancerCode mutation panel are associated with tumor response will be assessed. In each sample, the presence or absence of mutations (0/1) for each gene on the panel will be evaluated. Each gene will be tested separately for its association with tumor response using a two-sample Mann-Whitney-Wilcoxon test with a type-I error of 0.05 for a two-sided test.


Original Primary Outcome: Same as current

Current Secondary Outcome: Tumor heterogeneity in patients with partial response to radiation [ Time Frame: Up to 3 years ]

Whether there are differences in the mutation profiles in the 4 tumor samples will be assessed, with differences being considered evidence of possible heterogeneity.


Original Secondary Outcome: Same as current

Information By: Fox Chase Cancer Center

Dates:
Date Received: May 6, 2014
Date Started: July 2014
Date Completion: July 2020
Last Updated: November 23, 2016
Last Verified: November 2016