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NCT04417699 · ClinicalTrials.gov registry record · Phase 2
SHOrt Course Radiation and TASOX (TAS102 Plus Oxaliplatin) Chemotherapy in Operable Rectal Cancer
A Phase 2 study, sponsored by Providence Health & Services.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT04417699: Completed Phase 2 study, sponsored by Providence Health & Services.
NCT04417699 is a Phase 2 study that has completed, run by Providence Health & Services. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04417699, a Phase 2 study, has completed, sponsored by Providence Health & Services.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
TASOX can be safely and efficaciously delivered after short course radiation, resulting in significant pathologic downstaging, allowing for an R0 pelvic resection, and providing local control in appropriately selected stage II/III rectal cancer patients treated with contemporary TME-based surgery.
Primary Outcome
Determine whether pre-operative short-course radiation therapy (SRT) and 6 cycles of TASOX offers condensed radiation and total neoadjuvant therapy for intermediate risk rectal cancer. Measurement of efficacy is the NAR score, where the required elements of the NAR score are: clinical tumor stage (cT), pathologic tumor stage (pT), pathological nodal stage (pN). For patients with a cCR who opted for non-operative management, for the purposes of the NAR score, those patients were assigned a pT0 a
Interventions
- DRUG Oxaliplatin
- DRUG TAS 102
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2022-07-05 |
| Est. Completion | 2024-02-21 |
| Phase | Phase 2 |
What the finished NCT04417699 record still lists
NCT04417699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Oxaliplatin is the first listed.
NCT04417699 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04417699 about?
NCT04417699 is a clinical study titled "SHOrt Course Radiation and TASOX (TAS102 Plus Oxaliplatin) Chemotherapy in Operable Rectal Cancer". TASOX can be safely and efficaciously delivered after short course radiation, resulting in significant pathologic downstaging, allowing for an R0 pelvic resection, and providing local control in appropriately selected stage II/III rectal cancer patients treated with contemporary TME-based surgery.
What is the current status of trial NCT04417699?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2022-07-05. Estimated completion is 2024-02-21.
What interventions are being tested in trial NCT04417699?
The interventions under investigation include: Oxaliplatin (DRUG), TAS 102 (DRUG).
Who is sponsoring clinical trial NCT04417699?
This trial is sponsored by Providence Health & Services, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04417699's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 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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