Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03781323 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant FOLFOX Therapy With Short Course Radiation and Active Surveillance in Locally Advanced Rectal Cancer
A Phase 2 study of Advanced Rectal Cancer, sponsored by University of Rochester.
- Active
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT03781323: Active Phase 2 study of Advanced Rectal Cancer, sponsored by University of Rochester.
NCT03781323 is a Phase 2 study of Advanced Rectal Cancer that is active but no longer recruiting, run by University of Rochester. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03781323, a Phase 2 study of Advanced Rectal Cancer, is active but no longer recruiting, sponsored by University of Rochester.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to evaluate the treatment of patients with locally advanced rectal cancer for complete response to neoadjuvant chemotherapy without the use of radiation and surgery.
Primary Outcome
* A complete response will consist of a digital rectal exam with normal appearing mucosa and sigmoidoscopy/proctoscopy with scarring but no nodularity or ulcerations. * A near complete response will consist of digital rectal exam with smooth or minor mucosal abnormalities, and sigmoidoscopy/proctoscopy with small mucosal abnormalities, or superficial ulceration or erythematous scarring. * Partial response, in our study, will be those tumors read with RECIST version 1.1 criteria with a ≥20% decre
Conditions Studied
Interventions
- DRUG FOLFOX
Study Locations (2)
New York
- University of Rochester, James P. Wilmot Cancer Center - Rochester
- University of Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-05-03 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 2 |
What the registry record for NCT03781323 still lists
NCT03781323 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Advanced Rectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which FOLFOX is the first listed.
NCT03781323 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03781323 about?
NCT03781323 is a clinical study titled "Neoadjuvant FOLFOX Therapy With Short Course Radiation and Active Surveillance in Locally Advanced Rectal Cancer". The purpose of this study is to evaluate the treatment of patients with locally advanced rectal cancer for complete response to neoadjuvant chemotherapy without the use of radiation and surgery.
What is the current status of trial NCT03781323?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2019-05-03. Estimated completion is 2027-06-01.
What conditions does trial NCT03781323 study?
This clinical trial studies the following conditions: Advanced Rectal Cancer.
What interventions are being tested in trial NCT03781323?
The interventions under investigation include: FOLFOX (DRUG).
Who is sponsoring clinical trial NCT03781323?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03781323 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03781323's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02602769 · 12 participants
Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome
- NCT02605421 · 12 participants · Phase 2
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
- NCT02619448 · 12 participants · Early Phase 1
Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC
- NCT03311503 · 12 participants · Phase 1
Phase I/II Trial of Lentiviral Gene Transfer for SCID-X1 With Low Dose Targeted Busulfan Conditioning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI