Clinical trial NCT01463423: Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
Official title: Trial of Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-small Cell Lung Cancer (NSCLC)
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-11-01
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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).

Primary outcomes:
measure: Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors.
timeFrame: 1 year
Secondary outcomes:
measure: Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors
timeFrame: 1 year
measure: Number of Participants Successfully Using an Optimized Breath-hold Technique During Stereotactic Ablative Radiotherapy (SABR) to Treat Lung Tumors
timeFrame: up to 2 years
measure: Number of Participants With a Difference in Treatment Delivery Time Using an Optimized Breath-hold Technique During Stereotactic Ablative Radiotherapy (SABR)
timeFrame: up to 2 years
measure: Number of Participants With Progression-free Survival (PFS)
timeFrame: up to 2 years
measure: Number of Participants With Metastasis-free Survival (MFS)
timeFrame: 2 years
measure: Number of Participants With Overall Survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Cancer Institute
state: California
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
Study officials:
affiliation: Stanford University
name: Maximilian Diehn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Bill Loo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: