Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

Stanford University

Status: Completed

Conditions: Non-small Cell Lung Cancer (NSCLC)

Treatments: Radiation: iSABR, 50 Gray in 4 fractions for medium peripheral tumors; Radiation: iSABR, 40 Gray in 4 fractions for small central tumors; Radiation: iSABR, 25 Gray in 1 fraction for small peripheral tumors; Radiation: iSABR, 60 Gray in 8 fractions for large central tumors; Radiation: iSABR, 50 Gray in 4 fractions for medium central tumors; Radiation: iSABR, 54 Gray in 3 fractions for large peripheral tumors

Study type: Interventional

Funder types: Other

Identifiers

NCT01463423

LUN0048 (Other Identifier)

IRB-22600 (Other Identifier)

SU-10202011-8537 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 256 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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256 participants in 3 patient groups

Limited Primary Non-small Cell Lung Cancer (NSCLC)

Experimental group

Description:

Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)

Treatment:

Radiation: iSABR, 50 Gray in 4 fractions for medium central tumors

Radiation: iSABR, 54 Gray in 3 fractions for large peripheral tumors

Radiation: iSABR, 60 Gray in 8 fractions for large central tumors

Radiation: iSABR, 25 Gray in 1 fraction for small peripheral tumors

Radiation: iSABR, 40 Gray in 4 fractions for small central tumors

Radiation: iSABR, 50 Gray in 4 fractions for medium peripheral tumors

History of NSCLC

Experimental group

Description:

Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)

Treatment:

Radiation: iSABR, 50 Gray in 4 fractions for medium central tumors

Radiation: iSABR, 54 Gray in 3 fractions for large peripheral tumors

Radiation: iSABR, 60 Gray in 8 fractions for large central tumors

Radiation: iSABR, 25 Gray in 1 fraction for small peripheral tumors

Radiation: iSABR, 40 Gray in 4 fractions for small central tumors

Radiation: iSABR, 50 Gray in 4 fractions for medium peripheral tumors

Advanced Lung Cancer Including Metastatic Lung Cancer

Experimental group

Description:

Participants with more advanced lung cancer or lung metastases from a variety of different cancers.

Treatment:

Radiation: iSABR, 50 Gray in 4 fractions for medium central tumors

Radiation: iSABR, 54 Gray in 3 fractions for large peripheral tumors

Radiation: iSABR, 60 Gray in 8 fractions for large central tumors

Radiation: iSABR, 25 Gray in 1 fraction for small peripheral tumors

Radiation: iSABR, 40 Gray in 4 fractions for small central tumors

Radiation: iSABR, 50 Gray in 4 fractions for medium peripheral tumors