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Completed Phase 2 Interventional

3-Dimensional Conformal Radiation Therapy Versus Intensity Modulated Radiation Therapy

ClinicalTrials.gov ID: NCT00520702

Public ClinicalTrials.gov record NCT00520702. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 11:32 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Trial to Compare Time to Common Toxicity Criteria for Adverse Effect (CTC AEC) 3.0 Grade. 3 Treatment Related Pneumonitis (TRP) in Patients With Locally Advanced Non-Small Cell Lung Carcinoma (NSCLC) Receiving Concurrent Chemoradiation Radiation Treated With 3-Dimensional Conformal Radiation Therapy (3D CRT, ARM 1) Versus Intensity Modulated Radiation Therapy (IMRT, ARM 2) Using 4-Dimensional CT Planning and Image Guided Adaptive Radiation Therapy (IGART)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00520702
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
168 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 20, 2007
Primary completion
Oct 2, 2018
Completion
Oct 2, 2018
Last update posted
Oct 4, 2018

2007 – 2018

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Texas MD Anderson Cancer Center Houston Texas 77030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00520702, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 4, 2018 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00520702 live on ClinicalTrials.gov.

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