CompletedNot Applicable

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

United States43 participantsStarted 2014-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of the randomly chosen samples that are successfully sequenced

Timeframe: Up to 3 years

Tumor response measured using the tumor regression grading system

Timeframe: Up to 3 years

Trial details

NCT IDNCT02132858

SponsorFox Chase Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-04-08

View on ClinicalTrials.gov More Mucinous Adenocarcinoma of the Rectum trials