- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Ancillary-Correlative (genetic mutation analysis)
Patients undergo collection of blood and tissue samples for analysis via sequencing.
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Correlative studies
Correlative studies
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Up to 3 years
|
Tumor response measured using the tumor regression grading system
Time Frame: Up to 3 years
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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.
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Up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Up to 3 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: Up to 3 years
|
PFS will be calculated using the methods of Kaplan and Meier.
If promising mutations are identified, survival between mutation positive and negative patients will be compared using the log-rank test.
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Up to 3 years
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Overall survival
Time Frame: Up to 3 years
|
OS will be calculated using the methods of Kaplan and Meier.
If promising mutations are identified, survival between mutation positive and negative patients will be compared using the log-rank test.
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Up to 3 years
|
Changes in mutation profiles
Time Frame: Baseline to up to 3 years
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Any differences between pre- and post- test results (a different mutation status for any gene on the panel) will be considered evidence of a change.
The overall proportion of patients exhibiting pre-post differences will be characterized, and particular genes of interest may be tested individually with an exact test of marginal homogeneity.
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Baseline to up to 3 years
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PET-computed tomography parameters
Time Frame: Up to 3 years
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Maximum standardized uptake value will be calculated, as well as textural measures such as coarseness, busyness, contrast, and complexity.
The Mann-Whitney-Wilcoxon tests will be used to examine association between image measures and response.
Image measures before and after radiation using the Wilcoxon signed rank test for paired data will be compared and differences in textural measures across tumor grades 0-3 will be assessed using the Kruskal-Wallis test.
Associations between textural measures and tumor mutation profiles will be explored, also using non-parametric tests.
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Up to 3 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joshua Meyer, Fox Chase Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Neoplasms, Cystic, Mucinous, and Serous
- Adenocarcinoma
- Rectal Neoplasms
- Cystadenocarcinoma
- Adenocarcinoma, Mucinous
Other Study ID Numbers
- CGI-066 (Other Identifier: Fox Chase Cancer Center)
- P30CA006927 (U.S. NIH Grant/Contract)
- NCI-2014-00719 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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