← Back to Search

Radiosensitizer

Radiation Therapy for Rectal Cancer

Phase 1
Waitlist Available
Led By Charles Kunos
Research Sponsored by National Cancer Institute (NCI)
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 up to 3 years
Awards & highlights

Study Summary

This trial is studying the side effects of a combination of ropidoxuridine and capecitabine when added to radiation therapy for treating patients with stage II-III rectal cancer.

Eligible Conditions
  • Rectal Cancer

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Dose-limiting Toxicities (Part IB)
Maximum-tolerated Dose
Secondary outcome measures
Change in Tissue Biomarker Levels
Neoadjuvant Rectal Score at the Maximum-tolerated Dose
Pathological Complete Response Rate at the Maximum-tolerated Dose
+2 more
Other outcome measures
Interactions of Capecitabine, IPdR and Their Metabolites
Relationship Between Extent of Exposure to Radiotherapy and Incidence and Severity of Adverse Events

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (ropidoxuridine, capecitabine, radiation therapy)Experimental Treatment3 Interventions
Patients receive ropidoxuridine PO QD over 7 days per week and capecitabine PO BID over 6 days per week for 6 weeks. Patients also undergo radiation therapy over 1 fraction per day for 5 days per week (Monday-Friday) during weeks 1-5 and for 3 days during week 6 in the absence of disease progression or unacceptable toxicity. Approximately 8-12 weeks after completion of treatment with ropidoxuridine, capecitabine, and radiation therapy, patients undergo standard of care surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3420
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,152 Total Patients Enrolled
Charles KunosPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
3 Previous Clinical Trials
77 Total Patients Enrolled
Timothy J KinsellaPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
1 Previous Clinical Trials
19 Total Patients Enrolled

Frequently Asked Questions

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

Are there still available slots to participate in this research experiment?

"According to clinicaltrials.gov, this research is still open for enrollment and has been amended most recently on the 11th of October 2022 since its initial posting on 7th October 2020."

Answered by AI

Have any prior experiments explored the potential of Radiation Therapy?

"The first research on radiation therapy took place in 2005 at Withington Hospital. Since then, 653 clinical trials have been conducted and concluded; presently 336 are ongoing with many of them being administered out of Salt Lake City, Utah."

Answered by AI

How many individuals are engaged in this clinical experiment?

"The current medical trial mandates that 30 eligible candidates partake in the experiment. Participants can be found at Huntsman Cancer Institute/University of Utah, located in Salt Lake City, and also Ohio State University Comprehensive Cancer Center based in Columbus."

Answered by AI

How many locales is the clinical trial current being conducted in?

"This medical experiment is being conducted in 10 different locations, three of which are the Huntsman Cancer Institute/University of Utah in Salt Lake City, Ohio State University Comprehensive Cancer Center in Columbus, and University of Kentucky/Markey Cancer Center Lexington."

Answered by AI

For what ailments is radiation treatment typically prescribed?

"Radiation Therapy is a commonly used form of treatment for malignant neoplasms. It has also been found to be effective in treating conditions such as pancreatic endocrine carcinoma, colorectal carcinoma, and refractory ovarian cancer."

Answered by AI

To what degree is Radiation Therapy considered a safe treatment option?

"The safety of Radiation Therapy is assigned a score of 1 based on the assessment from our team at Power, considering that this is only in Phase I and there has been limited research done with regards to efficacy and security."

Answered by AI

What is the primary goal of this clinical examination?

"The purpose of this trial, scheduled to last up to 38 days, is to identify the maximum-tolerated dose. Secondary goals comprise measuring percentage of ropidoxuridine incorporation in circulating granulocytes and peripheral blood counts with a target prevalence for grade 3/4 toxicity set at 30%. Furthermore, neoadjuvant rectal score will be estimated based on clinical T stage (cT), pathological T (pT) and pN stages while biomarker levels changes are assessed using Wilcoxon signed rank or McNemar's tests. Lastly, correlations between therapeutic response and baseline biomarkers or temporal alterations in biomarkers will"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing the Addition of a Radiation Sensitizing Drug, IPdR, to the Usual Chemotherapy Treatment (Capecitabine) During Radiation Therapy for Rectal Cancer
2021. "Testing the Addition of a Radiation Sensitizing Drug, IPdR, to the Usual Chemotherapy Treatment (Capecitabine) During Radiation Therapy for Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04406857.
~0 spots leftby Apr 2025
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