3-Dimensional Conformal Radiation Therapy Versus Intensity Modulated Radiation Therapy

Completed · Phase 2

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID: NCT00520702
Run by: M.D. Anderson Cancer Center
People needed: 168
Starts: 2007-08-21
Expected to finish: 2018-10-03
Last updated by the study team: 2018-10-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Pathologically proven diagnosis of unresected loco-regionally advanced non-small cell lung cancer without evidence of hematogenous metastases, Stages IIB-IIIB without contralateral hilar nodal disease.
Patient is suitable for concurrent chemoradiation therapy per treating physician's assessment (kps >/= 70, weight loss < 10% in three months prior to diagnosis).
Patients with Stage IV NSCLC with solitary metastasis (brain, one side of adrenal gland, or one site of bone), who have clinical indication of concurrent chemoradiation to the primary disease in the lung are eligible.
Patients who received induction chemotherapy and then referred for concurrent chemoradiation are eligible.
Patients who had local regional recurrence after surgical resection and who are suitable for definitive concurrent chemoradiation are eligible.
Measurable disease by chest x-ray and/or contrast-enhanced CT, and/or PET scan
FEV 1> 1000 cc
Pre-chemoradiation FDG-PET within 10 weeks prior to randomization. This PET/CT is a standard procedure for staging. It is strongly encouraged to have this PET/CT performed at the same time for 4-D CT simulation using the 4-D PET/CT scanner at the department of radiation oncology.
Patient will undergo routine standard pretreatment evaluations as decided by treating physician, which usually include magnetic resonance imaging (MRI) or CT of the brain, contrast CT scan of the thorax and upper abdomen, pulmonary functional test, single-photon emission computerized tomography (SPECT), liver function tests (LFT), blood chemistry, renal functional test, complete blood count.
Age > 18, < 80 years
Patient must sign study specific informed consent prior to study entry.

You may not qualify if…

Evidence of small cell histology
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Pregnant women are ineligible as the treatment involves unforeseeable risks to the participant and to the embryo or fetus. Patients with childbearing potential must practice appropriate contraception.
Patient has enrolled in a clinical trial that specifically does not allow IMRT treatment

Where it is running

University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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