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NCT04104139 · ClinicalTrials.gov registry record · Phase 1
TAS-102 With Concurrent Radiation for the Treatment of Untreated Resectable Stage II-III Rectal Cancer
A Phase 1 study of Rectal Adenocarcinoma and Stage III Rectal Cancer AJCC v8, sponsored by OHSU Knight Cancer Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT04104139: Active Phase 1 study of Rectal Adenocarcinoma and Stage III Rectal Cancer AJCC v8, sponsored by OHSU Knight Cancer Institute.
NCT04104139 is a Phase 1 study of Rectal Adenocarcinoma and Stage III Rectal Cancer AJCC v8 that is active but no longer recruiting, run by OHSU Knight Cancer Institute. The registered enrollment target is 19 participants, below the 123-participant average among 17 other Rectal Adenocarcinoma trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04104139, a Phase 1 study of Rectal Adenocarcinoma and Stage III Rectal Cancer AJCC v8, is active but no longer recruiting, sponsored by OHSU Knight Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase 1b trial studies the side effects and best dose of TAS-102 when given together with radiation therapy in treating patients with stage II-III rectal cancer that has not been treated and can be removed by surgery (resectable). Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out the safest dose of TAS-102 that can be used with radiation treatment for rectal cancer.
Primary Outcome
Will be assessed through the Bayesian optimal interval design and will be determined by the proportion of grade 3 or higher adverse events during chemo-radiation therapy (CRT) with TAS-102 at the MTD by allowing no more than 30% DLT. The proportion will be descriptively noted.
Conditions Studied
Interventions
- RADIATION Intensity-Modulated Radiation Therapy
- RADIATION 3-Dimensional Conformal Radiation Therapy
- DRUG Trifluridine and Tipiracil Hydrochloride
Study Locations (1)
Oregon
- OHSU Knight Cancer Institute - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-12-11 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 1 |
What the registry record for NCT04104139 still lists
NCT04104139 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 123-participant average among 17 other Rectal Adenocarcinoma trials with a reported enrollment target (85% lower).
The record links to 7 conditions, with Rectal Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which Intensity-Modulated Radiation Therapy is the first listed.
NCT04104139 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT04104139 about?
NCT04104139 is a clinical study titled "TAS-102 With Concurrent Radiation for the Treatment of Untreated Resectable Stage II-III Rectal Cancer". This phase 1b trial studies the side effects and best dose of TAS-102 when given together with radiation therapy in treating patients with stage II-III rectal cancer that has not been treated and can be removed by surgery (resectable). Drugs used in chemotherapy, such as TAS-102, work in different w...
What is the current status of trial NCT04104139?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2019-12-11. Estimated completion is 2026-05-31.
What conditions does trial NCT04104139 study?
This clinical trial studies the following conditions: Rectal Adenocarcinoma, Stage III Rectal Cancer AJCC v8, Stage IIIA Rectal Cancer AJCC v8, Stage IIIB Rectal Cancer AJCC v8, Stage IIIC Rectal Cancer AJCC v8.
What interventions are being tested in trial NCT04104139?
The interventions under investigation include: Intensity-Modulated Radiation Therapy (RADIATION), 3-Dimensional Conformal Radiation Therapy (RADIATION), Trifluridine and Tipiracil Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04104139?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04104139 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04104139's enrollment target sits among peer trials
19 18th of 17 the lowest of 17 other Rectal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rectal Adenocarcinoma 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.
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