Basic Trial Information
|Phase II, Phase I||Treatment||Closed||18 and over||NCI, Other||RTOG-0813|
CDR0000613524, NCI-2009-01095, NCT00750269
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 non-small cell lung cancer.
Further Study Information
- To determine the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT) in medically inoperable patients with centrally located stage I non-small cell lung cancer. (Phase I)
- To determine the efficacy of SBRT when administered at the MTD in these patients. (Phase I)
- To estimate the local control rate of SBRT at the MTD in these patients. (Phase II)
- To estimate the rates of adverse events (other than dose-limiting toxicity) of ≥ grade 3 that is possibly, probably, or definitely related to treatment and that occurs within 1 year after the start of SBRT in these patients.
- To estimate the rates of late adverse events (i.e., occurs > 1 year after the start of SBRT) in these patients.
- To estimate the local control and progression-free and overall survival rates in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo stereotactic body radiotherapy every 2 days over 1½-2 weeks (total of 5 fractions) in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically.
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage T1-2, N0, M0 disease
- Tumor must be 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 (i.e., 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) OR immediately adjacent to the mediastinal or pericardial pleura (PTV touching the pleura)
- Hilar or mediastinal lymph nodes ≤ 1 cm AND no abnormal hilar or mediastinal uptake on PET scan are considered N0
- Mediastinal lymph node sampling by any technique is allowed but not required
- Patients with > 1 cm hilar or mediastinal lymph nodes 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
- Tumor deemed technically resectable, in the opinion of an experienced thoracic cancer surgeon, with a reasonable possibility of obtaining a gross total resection with negative margins, defined as a potentially curative resection (PCR)
- Patient deemed "medically inoperable" due to severe underlying physiological medical problems that would prohibit a PCR, including any of the following:
- Baseline forced expiratory volume at one second (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 as documented by CT scan or whole-body PET scan within the past 8 weeks
- Patients with lesions that cannot be visualized by CT scan are not eligible
- Pleural effusion allowed provided it is deemed too small to tap under CT guidance and is not evident on chest x-ray
- Pleural effusion that appears on chest x-ray is allowed only after thoracotomy or other invasive procedure
- Zubrod performance status 0-2
- Fertile patients must use effective contraception during and for ≥ 60 days after completion of study therapy
- No other invasive malignancy within the past 2 years except nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
- Prior lung cancer allowed provided the patient has been disease-free for ≥ 2 years
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
- No prior chemotherapy for the study cancer
- No other concurrent local therapy (including standard-fractionated radiotherapy and/or surgery) or systemic therapy (including standard chemotherapy or biologic targeted agents) specifically intended as treatment for study cancer
- Local or systemic therapy at the time of disease progression allowed
Trial Lead Organizations/Sponsors
Radiation Therapy Oncology Group
- National Cancer Institute
- NRG Oncology
Andrea Bezjak, Principal Investigator
Jeffrey Bradley, Study Chair
Laurie Elizabeth Gaspar, Study Chair
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00750269
ClinicalTrials.gov processed this data on May 11, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.