Clinical trial NCT02262000: Phase II Image Guided Stereotactic Ablative Radiotherapy for Non-Small Cell Lung Cancer
Official title: A Phase II Clinical Trial of Image Guided Stereotactic Ablative Radiotherapy (SABR) for T2 and Microscopic T3 (PL3), N0,M0 Non-small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer
Surgically inoperable
Radiation Therapy
Lead sponsor: West Virginia University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2014-10-10
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will help researchers learn about the best dose of radiation to be used when treating large early stage non-small cell lung cancer (NSCLC) with a treatment called stereotactic ablative radiotherapy (SABR). Current treatments with SABR for early stage NSCLC show positive response. But, for large early stage NSCLC it may be better to give different SABR doses than what is used in routine early stage NSCLC treatment. It is not understood which dose is best for treating large early stage NSCLC. Therefore, this study can help researchers learn if giving a higher dose using SABR over a period of 5-10 treatment days can increase the chance of cure for large early stage NSCLC.

Detailed description: Treatment Plan:

7.5 Gy x 10 daily fractions delivered with volumetric modulated arc therapy (VMAT) or regular intensity-modulated radiation therapy (IMRT).

* Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal planning target volume (PTV) coverage is achieved; but the 7.5 Gy x 10 daily fractions schedule is preferred.
* All doses are prescribed to the tumor periphery.

For this protocol, patients will be followed only up to 2 years post radiation therapy.

Eligibility criteria: Inclusion Criteria:

* Non-Small Cell Lung Cancer
* T2N0M0 or T3(PL3)N0M0 or Locally recurrent ≤ 7 cm
* Surgically inoperable
* ECOG Performance 0-2

Exclusion Criteria:

* Pacemaker on the same side of the tumor
* Pregnant
* Infection that requires IV antibiotics
* Concomitant or adjuvant anti-neoplastic chemotherapy

Primary outcomes:
measure: Local Control Rate (Absence of Local Progression) Using SABR for Treatment of NSCLC
timeFrame: 2 years
Secondary outcomes:
measure: Best Response
timeFrame: 2 years
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Hospitals Mary Babb Randolph Cancer Center
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Malcolm Mattes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levy A, Guckenberger M, Hurkmans C, Nestle U, Belderbos J, De Ruysscher D, Faivre-Finn C, Le Pechoux C. SBRT Dose and Survival in Non-Small Cell Lung Cancer: In Regard to Koshy et al. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):945-6. doi: 10.1016/j.ijrobp.2015.03.032. No abstract available.