Clinical trial NCT02132858: Genetic Mutations in Blood and Tissue Samples in Predicting Response to Treatment in Patients With Locally Advanced Rectal Cancer Undergoing Chemoradiation
Official title: Assessing Intratumoral Heterogeneity and Chemoradiation Response in Locally Advanced Rectal Cancer Utilizing Sequencing and PET/CT
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-05-07
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient clinic

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of the randomly chosen samples that are successfully sequenced
timeFrame: Up to 3 years
measure: Tumor response measured using the tumor regression grading system
timeFrame: Up to 3 years
Secondary outcomes:
measure: Tumor heterogeneity in patients with partial response to radiation
timeFrame: Up to 3 years
Other outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to 3 years
measure: Overall survival
timeFrame: Up to 3 years
measure: Changes in mutation profiles
timeFrame: Baseline to up to 3 years
measure: PET-computed tomography parameters
timeFrame: Up to 3 years
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Joshua Meyer
role: PRINCIPAL_INVESTIGATOR
References: