3-Dimensional Conformal Radiation Therapy Versus Intensity Modulated Radiation Therapy
United States168 participantsStarted 2007-08-21
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. 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