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NCT01165658 · ClinicalTrials.gov registry record · Phase 1
Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01165658: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01165658 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01165658, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to study the safety of giving larger daily doses of proton radiation therapy than the standard dose levels given to treat lung cancer. Researchers want to find the highest daily dose of proton radiation that can be given without having to stop therapy due to side effects.
Primary Outcome
Dose-limiting toxicity (DLT) defined as any CTCAE v4.0 grade 4 complication of esophagus or skin, or any grade 3 or higher complications of other organ systems (i.e. lung, liver, kidney, or GI tract), unless these complications are deemed to be related to those of esophagus. DLT assessed within 1 month of completion of radiation therapy. MTD defined as highest dose for which probability of toxicity is closest to 25%.
Interventions
- RADIATION Proton Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-07-16 |
| Est. Completion | 2016-07-19 |
| Phase | Phase 1 |
Why NCT01165658 stopped before completion
NCT01165658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Proton Therapy is the first listed.
NCT01165658 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01165658 about?
NCT01165658 is a clinical study titled "Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies". The goal of this clinical research study is to study the safety of giving larger daily doses of proton radiation therapy than the standard dose levels given to treat lung cancer. Researchers want to find the highest daily dose of proton radiation that can be given without having to stop therapy due ...
What is the current status of trial NCT01165658?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2010-07-16. Estimated completion is 2016-07-19.
What interventions are being tested in trial NCT01165658?
The interventions under investigation include: Proton Therapy (RADIATION).
Who is sponsoring clinical trial NCT01165658?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01165658's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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