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NCT00915005 · ClinicalTrials.gov registry record · Phase 2
Trial of Image-Guided Adaptive Conformal Photon vs Proton Therapy, With Concurrent Chemotherapy, for Locally Advanced Non-Small Cell Lung Carcinoma: Treatment Related Pneumonitis and Locoregional Recurrence
A Phase 2 study of Non-Small-Cell Lung Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 275
- Enrollment target
- 2
- Study locations
NCT00915005: Completed Phase 2 study of Non-Small-Cell Lung Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT00915005 is a Phase 2 study of Non-Small-Cell Lung Carcinoma that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 275 participants, above the 227-participant average among 30 other Non-Small-Cell Lung Carcinoma trials with a reported enrollment target (21% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00915005, a Phase 2 study of Non-Small-Cell Lung Carcinoma, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 275 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this clinical research study is to learn if, compared with regular x-ray radiation, proton radiation reduces the risk of developing, treatment-related pneumonitis (TRP) or tumor recurrence (the tumor coming back in the irradiated area after treatment) in patients with lung cancer.
Primary Outcome
The Primary Objective is assess and compare the incidence and time to development of CTCAE v3.0 grade \> 3 TRP, among IMRT-Group 1 or PSPT-Group 2 using Bayesian randomization. TRP will be diagnosed clinically by the treating investigator. Any questions regarding the diagnosis or grade of TRP will be resolved by the Protocol PI or by his/her designee(s). The outcomes review committee will meet to discuss each and every patient reported to have developed symptomatic TRP. The final grading of TRP
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- RADIATION Proton Therapy
- RADIATION Photon Therapy
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2009-06 |
| Est. Completion | 2020-02-24 |
| Phase | Phase 2 |
What the finished NCT00915005 record still lists
NCT00915005 is an interventional study that assigns participants to a tested intervention. The registered 275 participants enrollment target is mid-sized for trials with a published cap, above the 227-participant average among 30 other Non-Small-Cell Lung Carcinoma trials with a reported enrollment target (21% higher).
The record links to 1 condition, with Non-Small-Cell Lung Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT00915005 reports a single indexed study location in Massachusetts, Texas.
Frequently Asked Questions
What is clinical trial NCT00915005 about?
NCT00915005 is a clinical study titled "Trial of Image-Guided Adaptive Conformal Photon vs Proton Therapy, With Concurrent Chemotherapy, for Locally Advanced Non-Small Cell Lung Carcinoma: Treatment Related Pneumonitis and Locoregional Recurrence". The goal of this clinical research study is to learn if, compared with regular x-ray radiation, proton radiation reduces the risk of developing, treatment-related pneumonitis (TRP) or tumor recurrence (the tumor coming back in the irradiated area after treatment) in patients with lung cancer.
What is the current status of trial NCT00915005?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 275 participants. The study started on 2009-06. Estimated completion is 2020-02-24.
What conditions does trial NCT00915005 study?
This clinical trial studies the following conditions: Non-Small-Cell Lung Carcinoma.
What interventions are being tested in trial NCT00915005?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Proton Therapy (RADIATION), Photon Therapy (RADIATION).
Who is sponsoring clinical trial NCT00915005?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00915005 being conducted?
This trial has 2 study locations across Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00915005's enrollment target sits among peer trials
275 6th of 30 higher than 25 of 30 other Non-Small-Cell Lung Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small-Cell Lung 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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