NCT04406857

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

Terminated Phase 1 Results posted Last updated 26 February 2025

What this trial tests

Phase 1 trial testing Capecitabine in Locally Advanced Rectal Carcinoma in 1 participant. Terminated before completion.

Timeline

17 March 2021

Primary endpoint
18 January 2023

18 January 2023

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	17 March 2021
Primary completion	18 January 2023
Estimated completion	18 January 2023
Sites	9 locations across United States

Drugs / interventions tested

• Capecitabine (capecitabine) — full drug profile →
• Radiation Therapy — full drug profile →
• Ropidoxuridine — full drug profile →

Conditions studied

• Locally Advanced Rectal Carcinoma — all drugs for Locally Advanced Rectal Carcinoma →
• Rectal Adenocarcinoma — all drugs for Rectal Adenocarcinoma →
• Stage II Rectal Cancer AJCC v8 — all drugs for Stage II Rectal Cancer AJCC v8 →
• Stage III Rectal Cancer AJCC v8 — all drugs for Stage III Rectal Cancer AJCC v8 →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Locally Advanced Rectal Carcinoma or Rectal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected and graded from baseline until completion of the study up to 1 year.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Ropidoxuridine, Capecitabine, Radiation Therapy)

Serious: 1/1 (100%)

Deaths: 0/1

Serious adverse events (1 terms)

Reaction	System	Treatment (Ropidoxuridine,…
Cecal inflammation	Gastrointestinal disorders	—

Most-reported serious reactions: Cecal inflammation.

Data from ClinicalTrials.gov NCT04406857 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Rectal tumor fragmentation as a response pattern following chemoradiation.
   Mills MN, Naz A, Sanchez J, Dessureault S, et al · · 2022 · cited 3× · PMID 36636056 · DOI 10.21037/jgo-22-477
2. A case report of typhlitis during novel use of ropidoxuridine-capecitabine-radiotherapy for treatment-naïve rectal cancer.
   Kunos CA, Piekarz R, Collins JM, Kinsella TJ. · · 2023 · PMID 37369852 · DOI 10.1007/s00280-023-04561-4