Trial record 1 of 1 for: NCT00843726

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Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

This study is currently recruiting participants.

Verified April 2013 by Roswell Park Cancer Institute

Sponsor:

Information provided by (Responsible Party):

Roswell Park Cancer Institute

ClinicalTrials.gov Identifier:

NCT00843726

First received: February 12, 2009

Last updated: April 23, 2013

Last verified: April 2013

History of Changes

Purpose

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I or stage II non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Radiation: stereotactic body radiation therapy	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:

Incidence of RTOG grade 3 or higher toxicity [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Correlation between blood and serum markers and survival and toxicity [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	98
Study Start Date:	September 2008
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).	Radiation: stereotactic body radiation therapy Patients undergo 1 or 3 high-dose fractions
Experimental: Arm II Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.	Radiation: stereotactic body radiation therapy Patients undergo 1 or 3 high-dose fractions

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843726

Locations

United States, New York
Roswell Park Cancer Institute	Recruiting
Buffalo, New York, United States, 14263-0001
Contact: AskRPCI 877-275-7724 AskRPCI@RoswellPark.org
United States, Ohio
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Gregory Videtic, MD 216-444-9797
Principal Investigator: Gregory Videtic, MD

Sponsors and Collaborators

Roswell Park Cancer Institute

Investigators

Principal Investigator:

Anurag K. Singh, MD

Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00843726 History of Changes
Other Study ID Numbers:	I 124407, I 124407
Study First Received:	February 12, 2009
Last Updated:	April 23, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Roswell Park Cancer Institute:

stage I non-small cell lung cancer
stage II non-small cell lung cancer

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013

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