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

Temple University Health System (TUHS)

Status: Completed

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

Treatments: Other: laboratory biomarker analysis; Other: cytology specimen collection procedure

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02132858

P30CA006927 (U.S. NIH Grant/Contract)

NCI-2014-00719 (Registry Identifier)

CGI-066 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

43 participants in 1 patient group

Ancillary-Correlative (genetic mutation analysis)

Description:

Patients undergo collection of blood and tissue samples for analysis via sequencing.

Treatment:

Other: cytology specimen collection procedure

Other: laboratory biomarker analysis