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NCT00520702 · ClinicalTrials.gov registry record · Phase 2
3-Dimensional Conformal Radiation Therapy Versus Intensity Modulated Radiation Therapy
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 168
- Enrollment target
NCT00520702: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00520702 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 168 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00520702, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 168 participants
- Enrollment target
Study Summary
Primary Objective: * Developing Common Toxicity Criteria (CTC) 3.0 grade \> 3 treatment related pneumonitis (TRP) or * Developing local-regional recurrence among patients treated with 3D conformal radiation therapy (CRT) (Arm 1) or intensity modulated radiation therapy (IMRT) (Arm 2). Secondary Objectives: * To assess and compare the time to develop CTC 3.0 grade \> 3 radiation esophagitis in patients with non-small cell lung cancer (NSCLC) treated in arm 1 and arm 2. * To investigate the association of inflammatory cytokines with the time to the development of radiation pneumonitis and outcomes to concurrent chemoradiation between arm 1 and arm 2. * To investigate the association of relevant pharmacogenetics, biomarkers, and gene polymorphisms with the time to the development of radiation pneumonitis and treatment outcomes to concurrent chemoradiation between arm 1 and arm 2. * To evaluate image guided adaptive radiation therapy (IGART) using weekly computed tomography (CT) on rail or cone beam CT in the assessment of tumor response and impact on treatment planning and delivery. * To compare overall survival, progression-free survival, median survival time, in arm 1 and arm 2. * To evaluate the role of functional image of fluorodeoxyglucose-positron emission tomography (FDG-PET) in assessing and predicting the time to the development of TRP and tumor response. * To measure and compare symptom burden over time of the treatment using MD Anderson Symptom Inventory (MDASI)-Lung in the 2 arms. * To determine the impact of comorbid conditions on survival.
Interventions
- PROCEDURE Intensity Modulated Radiation Therapy
- PROCEDURE 3-Dimensional Conformal Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2007-08-21 |
| Est. Completion | 2018-10-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00520702
The ClinicalTrials.gov registry entry for NCT00520702 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 168 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intensity Modulated Radiation Therapy is the first listed.
NCT00520702 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00520702 about?
NCT00520702 is a clinical study titled "3-Dimensional Conformal Radiation Therapy Versus Intensity Modulated Radiation Therapy". Primary Objective: * Developing Common Toxicity Criteria (CTC) 3.0 grade \> 3 treatment related pneumonitis (TRP) or * Developing local-regional recurrence among patients treated with 3D conformal radiation therapy (CRT) (Arm 1) or intensity modulated radiation therapy (IMRT) (Arm 2). Secondary Ob...
What is the current status of trial NCT00520702?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2007-08-21. Estimated completion is 2018-10-03.
What interventions are being tested in trial NCT00520702?
The interventions under investigation include: Intensity Modulated Radiation Therapy (PROCEDURE), 3-Dimensional Conformal Radiation Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT00520702?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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