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NCT01629498 · ClinicalTrials.gov registry record · Phase 1
Image-Guided, Intensity-Modulated Photon or Proton Beam Radiation Therapy in Treating Patients With Stage II-IIIB Non-small Cell Lung Cancer
A Phase 1 study of Recurrent Lung Non-Small Cell Carcinoma and Stage IIIB Lung Non-Small Cell Cancer AJCC v7, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 146
- Enrollment target
- 1
- Study location
NCT01629498: Active Phase 1 study of Recurrent Lung Non-Small Cell Carcinoma and Stage IIIB Lung Non-Small Cell Cancer AJCC v7, sponsored by M.D. Anderson Cancer Center.
NCT01629498 is a Phase 1 study of Recurrent Lung Non-Small Cell Carcinoma and Stage IIIB Lung Non-Small Cell Cancer AJCC v7 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 146 participants, above the 114-participant average among 30 other Recurrent Lung Non-Small Cell Carcinoma trials with a reported enrollment target (28% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01629498, a Phase 1 study of Recurrent Lung Non-Small Cell Carcinoma and Stage IIIB Lung Non-Small Cell Cancer AJCC v7, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 146 participants
- Enrollment target
- 1
- Study location
Study Summary
This partially randomized phase I/II trial studies the side effects and best dose of image-guided, intensity-modulated photon or proton beam radiation therapy and to see how well they work in treating patients with stage II-IIIB non-small cell lung cancer. This trial is testing a new way of delivering radiation dose when only the tumor receives dose escalation while the surrounding normal structure is kept at standard level. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator (linac). The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Proton beam radiation therapy is a type of radiation therapy that uses streams of protons (tiny particles with a positive charge) to kill tumor cells. Both methods are designed to give a higher than standard dose of treatment to the tumor and may reduce the amount of radiation damage to healthy tissue near a tumor.
Primary Outcome
Will be defined as the highest simultaneous integrated boost volume (SIBV) dose that has posterior probability of dose-limiting toxicity (DLT) =\< 30%. DLT are defined as Common Terminology Criteria for Adverse Events (CTCAE) 4.0 grade 3+ acute radiation toxicity, including esophagitis, pneumonitis, and skin reaction that are definitely, or probably related to radiation treatment. Toxicities will be tabulated by dose, severity, and relationship to radiation therapy.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- RADIATION Intensity-Modulated Radiation Therapy
- RADIATION Image Guided Radiation Therapy
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2012-09-17 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 1 |
What the registry record for NCT01629498 still lists
NCT01629498 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, above the 114-participant average among 30 other Recurrent Lung Non-Small Cell Carcinoma trials with a reported enrollment target (28% higher).
The record links to 6 conditions, with Recurrent Lung Non-Small Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01629498 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01629498 about?
NCT01629498 is a clinical study titled "Image-Guided, Intensity-Modulated Photon or Proton Beam Radiation Therapy in Treating Patients With Stage II-IIIB Non-small Cell Lung Cancer". This partially randomized phase I/II trial studies the side effects and best dose of image-guided, intensity-modulated photon or proton beam radiation therapy and to see how well they work in treating patients with stage II-IIIB non-small cell lung cancer. This trial is testing a new way of deliveri...
What is the current status of trial NCT01629498?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 146 participants. The study started on 2012-09-17. Estimated completion is 2027-09-30.
What conditions does trial NCT01629498 study?
This clinical trial studies the following conditions: Recurrent Lung Non-Small Cell Carcinoma, Stage IIIB Lung Non-Small Cell Cancer AJCC v7, Stage II Non-Small Cell Lung Cancer AJCC v7, Stage IIA Non-Small Cell Lung Carcinoma AJCC v7, Stage IIB Non-Small Cell Lung Carcinoma AJCC v7.
What interventions are being tested in trial NCT01629498?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Intensity-Modulated Radiation Therapy (RADIATION), Image Guided Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT01629498?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01629498 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01629498's enrollment target sits among peer trials
146 5th of 30 higher than 26 of 30 other Recurrent Lung Non-Small Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Lung Non-Small Cell Carcinoma 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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