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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: Active NA study of Adenocarcinoma of the Lower Rectum, sponsored by Washington University School of Medicine.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
\- Criteria for clinical complete response: * No residual gross tumor at procto/sigmoidoscopy; or only erythematous scar or ulcer * No palpable tumor on DRE * No radiographic evidence of tumor on MRI * No suspicious mesorectal lymph nodes on MRI * Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2026-04-30 |
| Phase | NA |
What the registry record for NCT03904043 still lists
NCT03904043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03904043's enrollment target sits among peer trials
63 1157th of 2000 higher than 844 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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