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NCT00495040 · ClinicalTrials.gov registry record · Phase 2
Proton Radiotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT00495040: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00495040 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00495040, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if escalated/accelerated proton radiotherapy can improve the control of Non-Small Cell Lung Cancer (NSCLC) and decrease side effects. The safety of this treatment will also be studied. Objectives: To assess the therapeutic efficacy and toxicities of proton radiotherapy with escalated/accelerated dose for patients with medically inoperable stage I (T1-2, N0,M0) NSCLC. Primary goals: 1. Improve 2 years progression free survival at the primary site, and 2. reduce acute and chronic toxicity Secondary goals: 1. Improve disease specific survival at 2 years. 2. Study the potential of pre- and post treatment PET/CT in predicting clinical outcome. 3. Study the role of biomarkers in predicting therapeutic response and toxicities.
Primary Outcome
Chest CT with contrast (if possible) was used for evaluation of Local control. If is suspicious for recurrence by CT image, PET or PET/CT scan is required and biopsy is recommended to confirm the recurrence. Continuing CT or PET images follow up for un-confirmed recurrent disease. Timing of recurrence: at the time of first image (PET and/or CT) showing abnormalities. PET will use for progression free survival (PFS). Participants were followed up at 6 weeks after the completion of RT, every 3 mo
Interventions
- RADIATION Proton Radiotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2006-05-04 |
| Est. Completion | 2017-06-14 |
| Phase | Phase 2 |
What the finished NCT00495040 record still lists
NCT00495040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which Proton Radiotherapy is the first listed.
NCT00495040 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00495040 about?
NCT00495040 is a clinical study titled "Proton Radiotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)". The goal of this clinical research study is to learn if escalated/accelerated proton radiotherapy can improve the control of Non-Small Cell Lung Cancer (NSCLC) and decrease side effects. The safety of this treatment will also be studied. Objectives: To assess the therapeutic efficacy and toxicitie...
What is the current status of trial NCT00495040?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2006-05-04. Estimated completion is 2017-06-14.
What interventions are being tested in trial NCT00495040?
The interventions under investigation include: Proton Radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT00495040?
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 NCT00495040's enrollment target sits among peer trials
38 1467th of 2000 higher than 517 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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