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NCT01740648 · ClinicalTrials.gov registry record · Phase 1

Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Treating Patients With Stage II-III Rectal Cancer

A Phase 1 study, sponsored by Ohio State University Comprehensive Cancer Center.

Completed
Registry status
Phase 1
Development phase
19
Enrollment target

NCT01740648 is a Phase 1 study that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 19 participants.

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The verdict

NCT01740648, a Phase 1 study, has completed, sponsored by Ohio State University Comprehensive Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
19 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best dose of trametinib when given together with fluorouracil and radiation therapy before surgery in treating patients with stage II-III rectal cancer. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving trametinib together with fluorouracil and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed

Interventions

  • DRUG trametinib
  • DRUG fluorouracil
  • RADIATION radiation therapy

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2012-11-26
Est. Completion 2021-09-29
Phase Phase 1

What the Registry Record Tells You About NCT01740648

The ClinicalTrials.gov registry entry for NCT01740648 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University Comprehensive Cancer Center, which has 341 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which trametinib is the first listed.

NCT01740648 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01740648 about?

NCT01740648 is a clinical study titled "Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Treating Patients With Stage II-III Rectal Cancer". This phase I trial studies the side effects and best dose of trametinib when given together with fluorouracil and radiation therapy before surgery in treating patients with stage II-III rectal cancer. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growt...

What is the current status of trial NCT01740648?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2012-11-26. Estimated completion is 2021-09-29.

What interventions are being tested in trial NCT01740648?

The interventions under investigation include: trametinib (DRUG), fluorouracil (DRUG), radiation therapy (RADIATION).

Who is sponsoring clinical trial NCT01740648?

This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.