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

NCT ID: NCT00471835

Last Updated: 2017-01-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31

Brief Summary

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with stage I or stage II non-small cell lung cancer.

Detailed Description

OBJECTIVES:

Primary

• Determine the maximum tolerated dose of hypofractionated stereotactic body radiotherapy (SBRT) to the central lung region (peri-mediastinum) in patients with stage I or II non-small cell lung cancer. (Phase I)
• Determine local control and time to local progression in patients treated with this regimen. (Phase II)
• Evaluate the ability of peak standardized uptake values (SUV) for fludeoxyglucose F 18 (FDG)-PET scan, obtained shortly after SBRT (post-treatment), to predict local control and time to progression in these patients.

Secondary

• Evaluate the ability of maximum SUV for FDG-PET scan, obtained shortly after SBRT, to predict long-term local control and time to progression in these patients.
• Evaluate the ability of peak SUV and max SUV for FDG-PET scan, obtained prior to SBRT, to predict local control and time to progression in these patients.
• Determine the utility of PET/CT scan data in guiding treatment planning.
• Determine if treatment with radiotherapy involving high biological doses with limited treatment volume using these SBRT techniques achieves acceptable treatment-related toxicity.

OUTLINE: This is a phase I dose-escalation study followed by a phase II open-label study.

• Phase I: Patients undergo hypofractionated stereotactic body radiotherapy (SBRT) 3 times within a 2-week time frame.

Cohorts of 3-6 patients receive escalating doses of hypofractionated SBRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

• Phase II: Patients undergo hypofractionated SBRT at the MTD as in phase I. In both phases, patients undergo fludeoxyglucose F 18-PET/CT scans at baseline and at 12-16 weeks after completion of SBRT.

After completion of study treatment, patients are followed periodically for 4 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

computed tomography

Intervention Type: PROCEDURE

positron emission tomography

Intervention Type: PROCEDURE

stereotactic body radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Mediastinal lymph nodes must be ≤ 1 cm and no abnormal uptake on FDG-PET scan in those areas

• Patients with > 1 cm lymph nodes or abnormal FDG-PET scan (including suspicious but non-diagnostic uptake) are eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer
• No evidence of distant metastases

• Suspected M1 disease based on pre-treatment PET imaging must be biopsied

• If the biopsy is positive, the patient is ineligible
• If the biopsy is negative and representative of the lesion in question, the patient is eligible
• If the biopsy is non-diagnostic, consideration should be given to repeat biopsy

• If the repeat biopsy remains non-diagnostic or a biopsy is not feasible, then the patient is ineligible
• Technically resectable disease

• Surgery refused or patient deemed medically inoperable due to co-morbid conditions

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-2
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No synchronous primary or invasive malignancy within the past 2 years other than non-melanomatous skin cancer
• No active systemic, pulmonary, or pericardial infection

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior chest radiotherapy (lung or mediastinum)
• No other concurrent anticancer therapy, including other radiotherapy, radiofrequency ablation (or other antineoplastic interventional radiology techniques), chemotherapy, biological therapy, vaccine therapy, or surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Volker W. Stieber, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Other Identifiers

CDR0000543743

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU-IRB00000578

Identifier Type: -

Identifier Source: secondary_id

CCCWFU-62206

Identifier Type: -

Identifier Source: org_study_id