← Back to Search

Standard Treatment Response for Rectal Cancer

N/A
Recruiting
Led By Paul Romesser, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older on day of signing informed consent
Histologically confirmed diagnosis of invasive adenocarcinoma of the rectum with no known mismatch repair deficiency or Her2 amplification
Must not have
Patients on blood thinners prohibiting endoluminal tumor biopsies
Men or women not using effective contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to understand how the body reacts to standard treatments for rectal cancer, such as chemoradiation and chemotherapy. Researchers will analyze blood, tissue, and scan results to determine how effective

Who is the study for?
This trial is for individuals with rectal cancer, specifically adenocarcinoma. Participants will undergo standard treatments before potential surgery. The study aims to include those who can provide blood and tissue samples, as well as undergo scans.
What is being tested?
The trial is studying how people with rectal cancer respond to the usual treatment combo of chemoradiation and chemotherapy. It involves monitoring changes in the body through blood tests, tissue analysis, and imaging scans.
What are the potential side effects?
While not explicitly listed here, typical side effects from chemoradiation and chemotherapy may include fatigue, nausea, hair loss, skin irritation at radiation site, low blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My rectal cancer is confirmed and does not have specific genetic features.
Select...
I am starting standard chemotherapy for my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am on blood thinners that prevent me from having certain cancer tissue tests.
Select...
I am not using any form of birth control.
Select...
I have had radiation therapy to my pelvis or seed implantation in my prostate.
Select...
I do not have another cancer that could affect the study's safety or results.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical response

Side effects data

From 2008 Phase 2 & 3 trial • 58 Patients • NCT00510692
79%
Gastrointestinal
38%
Nervous system disorders
28%
Infections and infestations
24%
Musculoskeletal and connective tissue disorders
24%
General disorders
17%
Respiratory, thoracic and mediastinal disorders
14%
Injury, poisoning and procedural complications
7%
Neoplasms benign, malignant and unspecified
7%
Small bowel obstruction
3%
metabolism and nutritional disorders
3%
Breast cancer
3%
Endocrine disorders
3%
Immune system disorders
3%
Investigations
3%
Renal and urinary disorders
3%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
2g/Day Eicosapentanoic Acid (EPA)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with Rectal CancerExperimental Treatment1 Intervention
Participants will be diagnosed with rectal cancer and will be undergoing standard-of-care neoadjuvant therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endoscopy
2019
Completed Phase 3
~3480

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,972 Previous Clinical Trials
597,678 Total Patients Enrolled
Paul Romesser, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
68 Total Patients Enrolled
~20 spots leftby Oct 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top