A Phase II Randomized Study of 2 Stereotactic Body Radiation Therapy (SBRT) Regimens for Medically Inoperable Patients With Node Negative, Peripheral Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
A Phase II Randomized Study of 2 Stereotactic Body Radiation Therapy (SBRT) Regimens for Medically Inoperable Patients With Node Negative, Peripheral Non-Small Cell Lung Cancer
OBJECTIVES:
Primary
- To compare the incidence of toxicity with two established stereotactic body
radiotherapy (SBRT) regimens in patients with node-negative, peripheral stage I or II
non-small cell lung cancer.
Secondary
- To compare quality of life, patterns of failure, disease-free survival, and overall
survival of these patients after treatment with one of two established SBRT regimens.
- To correlate outcomes and toxicities with imaging and patient and tumor biomarkers.
OUTLINE: Patients are stratified according to Karnofsky performance status and treatment
center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
- Arm II: Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
Quality of life is assessed periodically by the EORTC QLQ-C30 and -LC13 questionnaires
Blood and tissue samples may be collected periodically and examined for biomarkers via ELISA
and immunoblotting.
After completion of study treatment, patients are followed for 5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed non-small cell lung cancer
- Node-negative disease
- Peripheral disease
- T1-T3, N0 disease measuring ≤ 5 cm
- No T2-T3 tumors > 5 cm or T3 tumor based on chest wall involvement
- Surgically resectable primary disease, but patient refuses surgery or is deemed to be
medically inoperable
- No metastatic disease
- No tumor within the zone of the proximal bronchial tree, defined as a volume of 2 cm
in all directions
PATIENT CHARACTERISTICS:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other conditions deemed by the PI or associates to make the patient ineligible for
protocol investigations, procedures, and high-dose external beam radiotherapy (e.g.,
unable to lie still and breathe reproducibly)
PRIOR CONCURRENT THERAPY:
- No prior thoracic radiotherapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of RTOG grade 3 or higher toxicity
Outcome Time Frame:
1year
Safety Issue:
Yes
Principal Investigator
Anurag K. Singh, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
I 124407
NCT ID:
NCT00843726
Start Date:
September 2008
Completion Date:
Related Keywords:
- Lung Cancer
- stage I non-small cell lung cancer
- stage II non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Cleveland Clinic | Cleveland, Ohio 44195 |
