CompletedPhase 2

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 range18 Years – 80 Years

SexALL

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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.
✓. 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.

What they're measuring

Time to Treatment Failure

Timeframe: 3 months after radiation therapy

Trial details

NCT IDNCT00520702

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10-03

View on ClinicalTrials.gov More Lung Cancer trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

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.
✓. 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.

3-Dimensional Conformal Radiation Therapy Versus Intensity Modulated Radiation Therapy

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

3-Dimensional Conformal Radiation Therapy Versus Intensity Modulated Radiation Therapy

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria