Image-Guided, Intensity-Modulated Photon or Proton Beam Radiation Therapy in Treating Patients With Stage II-IIIB Non-small Cell Lung Cancer
- Conditions
- Recurrent Lung Non-Small Cell CarcinomaStage II Non-Small Cell Lung Cancer AJCC v7Stage IIA Non-Small Cell Lung Carcinoma AJCC v7Stage IIB Non-Small Cell Lung Carcinoma AJCC v7Stage IIIA Non-Small Cell Lung Cancer AJCC v7Stage IIIB Lung Non-Small Cell Cancer AJCC v7
- Registration Number
- NCT01629498
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria:<br><br> - Pathologically proven diagnosis of unresected stage II-IIIB, or recurrent after<br> surgical resection or stereotactic body radiation therapy (SBRT) non-small cell lung<br> cancer<br><br> - Suitability for concurrent chemoradiation therapy per treating physician's<br> assessment<br><br> - Karnofsky performance status (KPS) score >= 70<br><br> - Weight loss < 15% in the 3 months before diagnosis<br><br> - Prior receipt of induction chemotherapy followed by referral for concurrent<br> chemoradiation is allowed<br><br> - Adequate lung function indicated by forced expiratory volume at 1 second (FEV1) >= 1<br> L is required<br><br> - The primary tumor and/or regional lymph nodes must be evaluable radiographically<br><br> - The gross target volume (GTV) is suitable for motion management using 4 dimensional<br> computed tomography (4D CT), internal target volume (ITV), or respiratory gating; in<br> addition, the target coverage and normal tissue constraints must be met as specified<br> in protocol accounting for the respiratory motion of anatomy as a whole (not just<br> the tumor)<br><br> - No prior radiation to the mediastinal structures<br><br> - Hemoglobin >= 9.0 g/dL<br><br> - Absolute neutrophil count (ANC) >= 1,500/mm^3<br><br> - Platelet count >= 100,000/mm^3<br><br> - Total bilirubin =< 1.5 times the upper limit of normal (ULN)<br><br> - Alanine and aspartate transaminases (ALT and AST) =< 2.5 times the ULN (=< 5 x ULN<br> for patients with liver involvement)<br><br> - Creatinine =< 1.5 times ULN<br><br> - Patients must sign an informed consent indicating that they are aware of the<br> investigational nature of the study in keeping with the policy of MD Anderson Cancer<br> Center (MDACC)<br><br>Exclusion Criteria:<br><br> - Prior radiotherapy to any anatomic regions that would result in overlap of radiation<br> dose distribution to critical structures (esophagus, heart, spinal cord, brachial<br> plexus)<br><br> - T4 tumor with direct invasion of esophagus, spinal cord, major blood vessel, or<br> heart<br><br> - Pregnancy<br><br> - Patients of childbearing potential must practice appropriate contraception<br><br> - Patient refusal
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) for intensity-modulated photon therapy (IMRT) (Phase I);MTD for intensity-modulated proton therapy (IMPT) (Phase I);Survival free of grade >= 3 toxicity (with a target of at least 75%) (Phase II);Local progression-free survival (75% at 6 months) d (Phase II)
- Secondary Outcome Measures
Name Time Method Time to local failure (Phase II);Progression-free survival (Phase II);Overall survival (Phase II);Posterior probability that the DLT rate 90 days from day 1 of radiation therapy is more than 30% (Phase II);Changes in selected biomarkers (Phase II);Change in symptom burden using European Quality of Life Five Dimension [EQ-5D]) (Phase II) Survey;Change in symptom burden using MD Anderson Symptom Inventory [MDASI]-Plus Survey