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NCT02319304 · ClinicalTrials.gov registry record · Phase 2
Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX for Patients With Newly Diagnosed Rectal Adenocarcinoma
A Phase 2 study, sponsored by University of Maryland, Baltimore.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT02319304: Clinical Trial Phase 2 study, sponsored by University of Maryland, Baltimore.
NCT02319304 is a Phase 2 study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02319304, a Phase 2 study, was terminated before completion, sponsored by University of Maryland, Baltimore.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effects, both good and bad, of adding very low dose fractionated radiation therapy (LDFRT) to the pelvis, with FOLFOX chemotherapy prior to surgery. Standard pelvic radiation therapy given once a day (Monday through Friday) over approximately 5.5 weeks is not given in this study. You will receive 6 cycles of FOLFOX (each cycle is 2 weeks) and you will also get an LDFRT to your pelvis given twice a day on the first two days of each cycle.
Primary Outcome
Overall survival rate of patients who receive a neoadjuvant full dose FOLFOX plus the addition of concurrent LDFRT result in a pCR response rate of at least 35%.
Interventions
- DRUG FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin}
- RADIATION Low dose fractionated radiation therapy (LDFRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2015-03 |
| Est. Completion | 2018-10-05 |
| Phase | Phase 2 |
Why NCT02319304 stopped before completion
NCT02319304 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin} is the first listed.
NCT02319304 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02319304 about?
NCT02319304 is a clinical study titled "Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX for Patients With Newly Diagnosed Rectal Adenocarcinoma". The purpose of this study is to assess the effects, both good and bad, of adding very low dose fractionated radiation therapy (LDFRT) to the pelvis, with FOLFOX chemotherapy prior to surgery. Standard pelvic radiation therapy given once a day (Monday through Friday) over approximately 5.5 weeks is n...
What is the current status of trial NCT02319304?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2015-03. Estimated completion is 2018-10-05.
What interventions are being tested in trial NCT02319304?
The interventions under investigation include: FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin} (DRUG), Low dose fractionated radiation therapy (LDFRT) (RADIATION).
Who is sponsoring clinical trial NCT02319304?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02319304's enrollment target sits among peer trials
3 2001st of 2000 the lowest 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
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