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NCT04130854 · ClinicalTrials.gov registry record · Phase 2
INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer
A Phase 2 study of Locally Advanced Rectal Adenocarcinoma, sponsored by University of Texas Southwestern Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 4
- Study locations
NCT04130854: Active Phase 2 study of Locally Advanced Rectal Adenocarcinoma, sponsored by University of Texas Southwestern Medical Center.
NCT04130854 is a Phase 2 study of Locally Advanced Rectal Adenocarcinoma that is active but no longer recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 58 participants, below the 97-participant average among 5 other Locally Advanced Rectal Adenocarcinoma trials with a reported enrollment target (40% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04130854, a Phase 2 study of Locally Advanced Rectal Adenocarcinoma, is active but no longer recruiting, sponsored by University of Texas Southwestern Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 4
- Study locations
Study Summary
Determine the complete pathologic complete response (pCR) rate in patients with locally advanced rectal adenocarcinoma.
Primary Outcome
The primary objective of this study is to determine the pathologic complete response (pCR) rate of the combined treatment modality.
Conditions Studied
Interventions
- DRUG APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days
- DRUG mFOLFOX and Radiation Therapy 5Gy x 5 days
Study Locations (4)
Arizona
- The University of Arizona Cancer Center - Tucson
North Carolina
- Wake Forest Baptist Health Sciences - Winston-Salem
Oregon
- Oregon Health & Science University - Portland
Texas
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2020-04-24 |
| Est. Completion | 2026-01-31 |
| Phase | Phase 2 |
What the registry record for NCT04130854 still lists
NCT04130854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 97-participant average among 5 other Locally Advanced Rectal Adenocarcinoma trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Locally Advanced Rectal Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days is the first listed.
NCT04130854 reports a single indexed study location in Arizona, North Carolina, Oregon.
Frequently Asked Questions
What is clinical trial NCT04130854 about?
NCT04130854 is a clinical study titled "INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer". Determine the complete pathologic complete response (pCR) rate in patients with locally advanced rectal adenocarcinoma.
What is the current status of trial NCT04130854?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2020-04-24. Estimated completion is 2026-01-31.
What conditions does trial NCT04130854 study?
This clinical trial studies the following conditions: Locally Advanced Rectal Adenocarcinoma.
What interventions are being tested in trial NCT04130854?
The interventions under investigation include: APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days (DRUG), mFOLFOX and Radiation Therapy 5Gy x 5 days (DRUG).
Who is sponsoring clinical trial NCT04130854?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04130854 being conducted?
This trial has 4 study locations across Arizona, North Carolina, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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