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

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.

Inclusion Criteria:

- Locally advanced rectal adenocarcinoma: T3-4NanyM0 or TanyN1-2M0

- Radiologically measurable or clinically evaluable disease

- Provide informed written consent

- Willing to return to enrolling medical site for all study assessments

Exclusion Criteria:

- Chemotherapy within 5 years prior to registration; (hormonal therapy is allowable if
the disease free interval is >= 5 years)

- Any prior pelvic radiation

- Patients who are at high risk of complications from temporarily discontinuing
anticoagulation for rectal cancer biopsies