Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Radiation Therapy Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00960999

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which regimen of stereotactic body 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 non-small cell lung cancer.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	A Randomized Phase II Study Comparing 2 Stereotactic Body Radiation Therapy (SBRT) Schedules for Medically Inoperable Patients With Stage I 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 National Cancer Institute (NCI):

Primary Outcome Measures:

1-year rate of ≥ grade 3 adverse events that are definitely, probably, or possibly related to treatment [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

1-year primary tumor control rate [ Designated as safety issue: No ]
1-year overall survival and disease-free survival rate [ Designated as safety issue: No ]
Distribution of FDG-PET standardized uptake value changes as a potential measure of treatment response and outcomes [ Designated as safety issue: No ]
Distribution of pulmonary function changes by treatment arm and response [ Designated as safety issue: Yes ]
Association between biomarkers, primary tumor control rate, and ≥ grade 2 radiation pneumonitis [ Designated as safety issue: No ]

Estimated Enrollment:	88
Study Start Date:	November 2009
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I (single fraction) Patients undergo one stereotactic body radiotherapy (SBRT) treatment to the target lesion.	Radiation: stereotactic body radiation therapy Given as a single fraction or in multiple fractions
Experimental: Arm II (multiple fractions) Patients undergo SBRT to the target lesion once daily for 4 days.	Radiation: stereotactic body radiation therapy Given as a single fraction or in multiple fractions

Detailed Description:

OBJECTIVES:

Primary

To determine the 1-year rate of ≥ grade 3 adverse events that are definitely, probably, or possibly related to treatment with single fraction vs multiple fraction stereotactic body radiotherapy in medically inoperable patients with stage I peripheral non-small cell lung cancer.

Secondary

To estimate the 1-year primary tumor control rate in these patients.
To estimate the 1-year overall survival and disease-free survival rate of these patients.
To assess FDG-PET standardized uptake value changes as a measure of treatment response and outcomes.
To determine pulmonary function changes by treatment arm and response.
To determine the association between biomarkers and primary tumor control and/or ≥ grade 2 radiation pneumonitis.

OUTLINE: This is a multicenter study. Patients are stratified according to Zubrod performance status (0 vs 1 vs 2) and T stage (T1 vs T2). Patients are randomized to 1 of 2 treatment arms.

Arm I (single fraction): Patients undergo one stereotactic body radiotherapy (SBRT) treatment to the target lesion.
Arm II (multiple fractions): Patients undergo SBRT to the target lesion once daily for 4 days.

Blood and tumor tissue samples may be collected for further analysis.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed primary non-small cell lung cancer, including one of the following subtypes:
- Squamous cell carcinoma
- Adenocarcinoma
- Large cell carcinoma
- Large cell neuroendocrine carcinoma
- Non-small cell carcinoma not otherwise specified
Stage T1-2, N0, M0 disease
- Tumor size ≤ 5 cm
- Hilar or mediastinal lymph nodes ≤ 1 cm with no abnormal hilar or mediastinal uptake on PET scan are considered N0
  - Patients with hilar or mediastinal lymph nodes > 1 cm on CT scan or abnormal PET scan (including suspicious but nondiagnostic uptake) are eligible provided directed tissue biopsies of all abnormally identified areas are negative for cancer
- No regional or distant metastases
Peripherally located tumor
- No primary tumor within or touching the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
- No involvement of the central pleura and/or structures of the mediastinum
Resectable disease
- Patient may have declined surgery after consulting with a thoracic surgeon
Patient deemed "medically inoperable", in the opinion of an experienced thoracic cancer clinician (thoracic surgeon, medical oncologist, radiation oncologist, or pulmonologist), due to a severe underlying physiological medical problem that would preclude surgery, including any of the following:
- Baseline FEV1 < 40% predicted
- Postoperative FEV1 < 30% predicted
- Severely reduced diffusion capacity
- Baseline hypoxemia and/or hypercapnia
- Exercise oxygen consumption < 50% predicted
- Severe pulmonary hypertension
- Diabetes mellitus with severe end-stage organ damage
- Severe cerebral, cardiac, or peripheral vascular disease
- Severe chronic heart disease
Measurable disease

PATIENT CHARACTERISTICS:

Zubrod performance status 0-2
ANC ≥ 1,800/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No synchronous primary malignancy or other malignancy within the past 2 years except for any of the following:
- Invasive malignancy that was definitively treated and patient remains disease free for > 3 years with a life expectancy of > 3 years
- Carcinoma in situ
- Early stage skin cancer that was definitively treated
No active systemic, pulmonary, or pericardial infection

PRIOR CONCURRENT THERAPY:

No prior radiotherapy to the lung or mediastinum
No prior chemotherapy for this lung or mediastinal tumor
- Prior chemotherapy for another invasive malignancy allowed provided it was definitively treated and patient remains disease free for > 3 years
No prior surgery for this lung or mediastinal tumor
No other concurrent antineoplastic therapy, including standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy, and/or surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960999

Show 38 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Gregory Videtic, MD

The Cleveland Clinic

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:	Walter John Curran, Jr, Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:	NCT00960999 History of Changes
Other Study ID Numbers:	CDR0000652101, RTOG-0915
Study First Received:	August 16, 2009
Last Updated:	March 24, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I non-small cell lung cancer
squamous cell lung cancer
adenocarcinoma of the lung
large 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 February 09, 2012