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NCT03904043 · ClinicalTrials.gov registry record · NA

Non-Operative Management and Early Response Assessment in Rectal Cancer

A NA study of Adenocarcinoma of the Lower Rectum, sponsored by Washington University School of Medicine.

Active
Registry status
NA
Development phase
63
Enrollment target
4
Study locations

NCT03904043 is a NA study of Adenocarcinoma of the Lower Rectum that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 63 participants. The trial reports 4 study locations across 4 states.

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The verdict

NCT03904043, a NA study of Adenocarcinoma of the Lower Rectum, is active but no longer recruiting, sponsored by Washington University School of Medicine.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
63 participants
Enrollment target
4
Study locations

Study Summary

The investigators' data from a phase I study of short course radiation therapy followed by chemotherapy showed 74% complete clinical response (cCR). Given the promising response rate, the investigators are evaluating short course radiation therapy (SCRT) followed by chemotherapy in a multi-institution phase II trial to validate the cCR rate of this treatment paradigm. SCRT has not been prospectively evaluated in non-operative management for patients with non-metastatic rectal adenocarcinoma.

Interventions

  • RADIATION Radiation therapy
  • DRUG FOLFOX regimen
  • DRUG CAPOX regimen

Study Locations (4)

Colorado

  • University of Colorado - Aurora

Minnesota

  • Mayo Clinic - Rochester

Missouri

  • Washington University School of Medicine - St Louis

Vermont

  • University of Vermont Medical Center - Burlington

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2020-07-01
Est. Completion 2026-04-30
Phase NA

What the Registry Record Tells You About NCT03904043

The ClinicalTrials.gov registry entry for NCT03904043 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Adenocarcinoma of the Lower Rectum appearing as the primary indexed condition, and to 3 interventions - of which Radiation therapy is the first listed.

NCT03904043 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Colorado, Minnesota, Missouri.

Frequently Asked Questions

What is clinical trial NCT03904043 about?

NCT03904043 is a clinical study titled "Non-Operative Management and Early Response Assessment in Rectal Cancer". The investigators' data from a phase I study of short course radiation therapy followed by chemotherapy showed 74% complete clinical response (cCR). Given the promising response rate, the investigators are evaluating short course radiation therapy (SCRT) followed by chemotherapy in a multi-instituti...

What is the current status of trial NCT03904043?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 63 participants. The study started on 2020-07-01. Estimated completion is 2026-04-30.

What conditions does trial NCT03904043 study?

This clinical trial studies the following conditions: Adenocarcinoma of the Lower Rectum.

What interventions are being tested in trial NCT03904043?

The interventions under investigation include: Radiation therapy (RADIATION), FOLFOX regimen (DRUG), CAPOX regimen (DRUG).

Who is sponsoring clinical trial NCT03904043?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03904043 being conducted?

This trial has 4 study locations across Colorado, Minnesota, Missouri, Vermont. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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.