PET/CT-directed Hyperfractionated Radiation Dose Escalation in Stage III Non-small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional

Summary: 
      The goal of this study is to find the maximum tolerable dose of radiation that can be
      delivered combined with chemotherapy (carboplatin & paclitaxel) in patients with stage III
      non-small cell lung cancer (NSCLC).
    

Detailed description: 
      Concurrent chemoradiotherapy is the standard of care for unresectable stage III NSCLC based
      on the results of phase III randomised trials. The current standard radiation therapy dose
      has remained 60- Gy at -2 Gy/fraction for nearly four decades (60Gy), with local disease
      control rates of approximately 50% and a median overall survival of only 18 months.These
      results are suboptimal and more effective treatment regimens are needed.

      We hypothesize that hyperfractionated radiation dose escalation to residual tumor volumes
      after standard chemoradiotherapy as defined by positron emission tomography (PET) /computed
      tomography (CT) would improve local control and overall survival while reducing the acute and
      late normal tissue toxicity.
    

Intervention name(s): radiochemotherapy 1; radiochemotherapy 2; radiochemotherapy 3; radiochemotherapy 4; radiochemotherapy 5; radiochemotherapy 6; radiochemotherapy 7
Intervention type(s): Radiation; Radiation; Radiation; Radiation; Radiation; Radiation; Radiation
Intervention description(s): concurrent radiochemotherapy: radiotherapy dose level 1: 60 Gy at 2 Gy/Fx/d, then 4.8 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly; concurrent radiochemotherapy: radiotherapy dose level 2: 60 Gy at 2 Gy/Fx/d, then 9.6 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly; concurrent radiochemotherapy: radiotherapy dose level 3: 60 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly; concurrent radiochemotherapy: radiotherapy dose level 4: 60 Gy at 2 Gy/Fx/d, then 19.2 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly; concurrent radiochemotherapy: radiotherapy dose level 5: 60 Gy at 2 Gy/Fx/d, then 4.8x5 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly; concurrent radiochemotherapy: radiotherapy dose level 6: 60 Gy at 2 Gy/Fx/d, then 4.8x6 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly; concurrent radiochemotherapy: radiotherapy dose level 7: 60 Gy at 2 Gy/Fx/d, then 4.8x7 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
Other intervention name(s): concurrent chemoradiotherapy regimen 1; concurrent chemoradiotherapy regimen 2; concurrent chemoradiotherapy regimen 3; concurrent chemoradiotherapy regimen 4; concurrent chemoradiotherapy regimen 5; concurrent chemoradiotherapy regimen 6; concurrent chemoradiotherapy regimen 7
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment