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Clinical trialNCT04406857TerminatedPhase 1Interventional

Testing the Addition of a Radiation Sensitizing Drug, IPdR, to the Usual Chemotherapy Treatment (Capecitabine) During Radiation Therapy for Rectal Cancer

SponsorNational Cancer Institute (NCI)Enrollment1Locally Advanced Rectal CarcinomaRectal AdenocarcinomaStage II Rectal Cancer AJCC v8Stage III Rectal Cancer AJCC v8
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase I trial studies the side effects and best dose of ropidoxuridine and how well it works when added to the usual chemotherapy treatment (capecitabine) during radiation therapy for the treatment of patients with stage II-III rectal cancer. Ropidoxuridine may help radiation therapy work better by making cancer cells more sensitive to the radiation therapy. Chemotherapy drugs, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out whether ropidoxuridine in addition to capecitabine and radiation therapy works better in treating patients with rectal cancer.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Charles Kunos

    University Health Network Princess Margaret Cancer Center LAO

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Los Angeles County-Usc Medical Center

    Los Angeles, California, United States

  • Usc / Norris Comprehensive Cancer Center

    Los Angeles, California, United States

  • University of Kentucky/markey Cancer Center

    Lexington, Kentucky, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, United States

  • University of Pittsburgh Cancer Institute (upci)

    Pittsburgh, Pennsylvania, United States

  • Rhode Island Hospital

    Providence, Rhode Island, United States

  • Huntsman Cancer Institute/university of Utah

    Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Capecitabine →Ropidoxuridine
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
17 Mar 2021
Primary completion
18 Jan 2023
Completion
18 Jan 2023
Last update posted
26 Feb 2025
Registered enrollment
1
Registry id
NCT04406857

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.