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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
13,717 Previous Clinical Trials
40,953,313 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
~0 spots leftby Jun 2025
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