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Radiation

Radiotherapy for Rectal Cancer (ROBIN Trial)

N/A
Recruiting
Led By Encouse Golden, M.D., Ph.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 1, week 6
Awards & highlights

ROBIN Trial Summary

This trial studies rectal cancer, its treatment with radiotherapy, and its effects on the immune system.

Who is the study for?
Adults over 18 with a specific type of rectal cancer that hasn't spread far or been treated yet. They must be in good health, not pregnant, and willing to use birth control. People can't join if they've had certain treatments before, have more advanced cancer, are on strong immune system drugs, or have other serious health issues.Check my eligibility
What is being tested?
The trial is testing how standard short course radiation therapy affects the immune response in rectal cancer patients who will also undergo surgery called Total Mesenteric Excision. It's for those whose cancer hasn't spread too much and aims to understand treatment effects better.See study design
What are the potential side effects?
Short course radiation may cause side effects like skin irritation at the treatment site, fatigue, bowel changes such as diarrhea or discomfort, and possibly bladder symptoms. Surgery risks include bleeding, infection, pain and potential impacts on bowel function.

ROBIN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1, week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, week 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of research specimens obtained after RT.
Number of research specimens obtained at the time of surgery.
Number of research specimens obtained before RT.
+1 more
Secondary outcome measures
Changes in Cellular stress (quantification of reactive Oxygen species (ROS))
Changes in enhancement kinetics from pre-treatment and post-treatment CT will be measured.
Changes in enhancement kinetics from pre-treatment and post-treatment MRI will be measured.
+10 more

ROBIN Trial Design

1Treatment groups
Experimental Treatment
Group I: Single cohortExperimental Treatment2 Interventions
Eligible patients will receive short course radiation therapy (scRT) of 25Gy over 5 days (fractions) for their localized rectal cancer. Research bloods stool and tissue will be collected at three time points: Baseline, end of radiation therapy and at surgery.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,270 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,416 Total Patients Enrolled
Silvia Formenti, M.D.Study ChairWeill Medical College of Cornell University
13 Previous Clinical Trials
1,294 Total Patients Enrolled

Media Library

Short Course Radiation Therapy (scRT) (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05943210 — N/A
Colorectal Cancer Research Study Groups: Single cohort
Colorectal Cancer Clinical Trial 2023: Short Course Radiation Therapy (scRT) Highlights & Side Effects. Trial Name: NCT05943210 — N/A
Short Course Radiation Therapy (scRT) (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05943210 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites in the city are administering this experiment?

"Weill Cornell Medical College in New york, New York Presbyterian Hospital - Queens in Chicago, Illinois, and The University of Chicago in New Brunswick are among the 9 participating medical centres."

Answered by AI

What is the current size of the cohort for this experiment?

"Affirmative. Data accessible through clinicaltrials.gov confirms that this experiment is presently recruiting participants, having been initially published on May 22nd 2023 and last updated July 3rd 2023. 25 test subjects are being sought from 6 distinct medical facilities."

Answered by AI

Is the current enrollment restricted to individuals over forty years old?

"This research is seeking volunteers who are aged between 18 and nonaginta years old."

Answered by AI

Is it possible to register for this research project?

"Aspiring participants of this clinical trial must possess a diagnosis of colorectal cancer, and be between 18-90 years old. This study is graciously admitting up to 25 people in total."

Answered by AI

Are there any vacancies available to take part in this research?

"Indeed, the data hosted on clinicaltrials.gov shows that this experimental study is currently in need of participants and was updated as recently as July 3rd 2023. 25 people are required to be recruited from 6 different medical centres."

Answered by AI

What are the key aims of this clinical investigation?

"This trial is set to run for 6 weeks and will assess the number of research specimens obtained after radiation therapy. Secondary outcomes being measured are changes in enhancement kinetics from pre-treatment and post-treatment CTs, functional diffusion patterns from pre-treatment and post-treatment MRI scans, as well as immunological fitness related to radio-responsiveness via gamma-H2aX (aging) quantification. To do this, conventional radiomics methods combined with deep learning based radiomics (DLR) approaches will be applied in order extract detailed information on these parameters at each time point."

Answered by AI
~16 spots leftby Oct 2025