Recurrent Rectal Cancer Clinical Trial
Official title:
Assessing Intratumoral Heterogeneity and Chemoradiation Response in Locally Advanced Rectal Cancer Utilizing Sequencing and PET/CT
Verified date | May 2024 |
Source | Fox Chase Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | October 2022 |
Est. primary completion date | April 8, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Fox Chase Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Progression-free survival (PFS) | 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. | Up to 3 years | |
Other | Overall survival | 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. | Up to 3 years | |
Other | Changes in mutation profiles | 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. | Baseline to up to 3 years | |
Other | PET-computed tomography parameters | 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. | Up to 3 years | |
Primary | Proportion of the randomly chosen samples that are successfully sequenced | If >= 90% of the specimens (at least 72 out of 80) are useable, the method will be considered feasible. | Up to 3 years | |
Primary | Tumor response measured using the tumor regression grading system | 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. | Up to 3 years | |
Secondary | Tumor heterogeneity in patients with partial response to radiation | Whether there are differences in the mutation profiles in the 4 tumor samples will be assessed, with differences being considered evidence of possible heterogeneity. | Up to 3 years |
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