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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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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