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

NCT02132858 | Completed DMC

• 3 other identifiers: CGI-066NCI-2014-00719P30CA006927
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Tumor heterogeneity in patients with partial response to radiation

  Up to 3 years

Other Outcomes (4)

• Progression-free survival (PFS)

  Up to 3 years

• Overall survival

  Up to 3 years

• Changes in mutation profiles

  Baseline to up to 3 years

Study Arms (1)

Ancillary-Correlative (genetic mutation analysis)

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

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

Interventions

cytology specimen collection procedure OTHER

Correlative studies

Also known as: cytologic sampling

Ancillary-Correlative (genetic mutation analysis)

laboratory biomarker analysis OTHER

Correlative studies

Ancillary-Correlative (genetic mutation analysis)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatient clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Joshua Meyer

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 7, 2014
• Study Start: July 1, 2014
• Primary Completion: April 8, 2022
• Study Completion: October 1, 2022
• Last Updated: May 2, 2024

Record last verified: 2024-05

Locations

US (1)