Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

Trial of Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

A research study of a procedure to treating lung cancer with focused radiation called Stereotactic Ablative Radiotherapy (SABR). The purpose of this study is to evaluate the effectiveness of individualizing the dose of radiation used to treat lung tumors with SABR based on tumor-specific factors.

While recent research has identified SABR as a promising method to increase local control (LC) of lung cancer, further research has indicated that tumor volume is a prognostic factor, with increased size/volume of tumor being associated with poorer outcomes. This study explores if a volume-adapted strategy for the radiologic exposure (dose) will improve efficacy in larger tumors (ie, > 10 cc).

This is a study of the procedure stereotactic ablative radiotherapy (SABR). It is not a study of a specific drug or device.

INCLUSION CRITERIA

• Limited primary non-small cell lung cancers (NSCLC) (ie, graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0), or metastatic lung tumors with no evidence of uncontrolled extrathoracic metastases.

• Up to 4 lesions may be considered.

  • For a single lesion, the sum of three orthogonal diameters can be no more than 20 cm.
  • For multiple lesions, no lesion can have a sum of orthogonal diameters greater than 15 cm.

• Both peripheral and central tumors are accepted for this trial.

• Age ≥ 18 years old

• Patients may be enrolled more than once (eg, for a new tumor lesion)

EXCLUSION CRITERIA

• Contraindication for radiotherapy
• Pregnant and breastfeeding women are excluded
• If prior radiation therapy, there is no overlap with the prior high dose regions (EXCEPTION: by approval of the investigators).