CompletedNot applicableNCT01463423

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.

Checked against the public recordLast updated Dec 19, 2024 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations4
SponsorStanford University
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
Stanford University
Interventions being studied
Radiation: iSABR, 25 Gray in 1 fraction for small peripheral tumors; Radiation: iSABR, 50 Gray in 4 fractions for medium peripheral tumors; Radiation: iSABR, 54 Gray in 3 fractions for large peripheral tumors; Radiation: iSABR, 40 Gray in 4 fractions for small central tumors; Radiation: iSABR, 50 Gray in 4 fractions for medium central tumors; Radiation: iSABR, 60 Gray in 8 fractions for large central tumors
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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).

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Stanford University Cancer InstituteStanford, California
  • Swedish Cancer InstituteSeattle, Washington
  • Princess Margaret Cancer CenterToronto, Ontario
  • Hokkaido University HospitalSapporo, Hokkaido

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 19, 2024. Always confirm current availability with the study team.

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