Stereotactic Body Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00087438|
Recruitment Status : Completed
First Posted : July 12, 2004
Results First Posted : April 7, 2014
Last Update Posted : January 16, 2019
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Stereotactic body radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with inoperable stage I or stage II non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Radiation: stereotactic body radiation therapy||Phase 2|
- Determine whether treatment with stereotactic body radiotherapy results in acceptable local control (i.e., ≥ 80%) in patients with medically inoperable stage I or II non-small cell lung cancer.
- Determine treatment-related toxicity in patients treated with this therapy.
- Determine disease-free survival, overall survival, and patterns of failure in patients treated with this therapy.
OUTLINE: This is a multicenter study.
Patients receive 3 fractions of stereotactic body radiotherapy over 8-14 days in the absence of disease progression or unacceptable toxicity.
Patients are followed up at 6 and 12 weeks, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 26 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients With Medically Inoperable Stage I/II Non-Small Cell Lung Cancer|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||December 2016|
Experimental: Stereotactic body radiation therapy (SBRT)
20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy
Radiation: stereotactic body radiation therapy
- Local Control at 2 Years [ Time Frame: From the start of treatment to 2 years ]Local control is defined as absence of local failure, which is defined as the combination of primary tumor failure (PTF) or involved lobe failure (ILF). PTF was defined based on meeting two criteria: 1. Local enlargement defined as ≥ 20% increase in the longest diameter of the gross tumor volume (GTV) per computerized tomography (CT), and 2. Evidence of tumor viability. Tumor viability could be affirmed by either demonstrating positron emission tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, or by repeat biopsy confirming carcinoma. PTF included marginal failures occurring within 1 cm of the planning target volume (PTV). ILF is defined as failure beyond the primary tumor but within the involved lobe. Local control time is defined as time from start of treatment to the the date of local recurrence, last known follow-up (censored), or death without local failure (censored). Rates are estimated using the Kaplan-Meier method.
- Proportion of Subjects With Specified Adverse Events [ Time Frame: From randomization to last follow-up. Analysis occurred after all patients had been on study for at least 2 years. Maximum follow-up at time of analysis was 4.2 years. ]
Specified adverse events are defined as any treatment-related adverse events that are grade 4, grade 5, or any of the following treatment-related grade 3 adverse events:
- Gastrointestinal: dysphagia, esophagitis, esophageal stricture, esophageal ulceration;
- Cardiac: pericarditis, pericardial effusion, cardiomyopathy, ventricular dysfunction;
- Neurologic: myelitis, neuropathy (cranial and motor)
- Hemorrhage: pulmonary or upper respiratory
- Pulmonary: decline in pulmonary function as measured by pulmonary function tests, pneumonitis, pulmonary fibrosis, hypoxemia, pleural effusion.
Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
- Rate of Local Recurrence at 2 Years [ Time Frame: From the start of treatment to 2 years ]Local failure is defined as the combination of primary tumor failure (PTF) or involved lobe failure (ILF). PTF was defined based on meeting two criteria: 1. Local enlargement defined as ≥ 20% increase in the longest diameter of the gross tumor volume (GTV) per computerized tomography (CT), and 2. Evidence of tumor viability. Tumor viability could be affirmed by either demonstrating positron emission tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, or by repeat biopsy confirming carcinoma. PTF included marginal failures occurring within 1 cm of the planning target volume (PTV). ILF is defined as failure beyond the primary tumor but within the involved lobe. Time to local recurrence is defined as time from start of treatment to the the date of local recurrence, last known follow-up (censored), or death without local recurrence (censored).
- Rate of Regional Recurrence at 2 Years [ Time Frame: From the start of treatment to 2 years ]Regional recurrence is defined as hilar, mediastinal, and supraclavicular nodal failure.Time to regional recurrence is defined as time from start of treatment to the date of first regional recurrence, last known follow-up (censored), or death without regional recurrence (competing risk). Rates are estimated using the cumulative incidence method.
- Rate of Disseminated Recurrence at 2 Years [ Time Frame: From the start of treatment to 2 years ]Disseminated recurrence is defined as uninvolved lobe failures and failures beyond the lungs and regional lymph nodes. Time to disseminated recurrence is defined as time from start of treatment to the the date of disseminated recurrence, last known follow-up (censored), or death without disseminated recurrence (competing risk). Rates are estimated using the cumulative incidence method.
- Rate of Disease-free Survival at 2 Years [ Time Frame: From the start of treatment to 2 years ]Disease is defined as local or regional progression or development of distant metastases. Disease-free survival time is defined as time from start of treatment to the date of disease, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method.
- Rate of Overall Survival at 2 Years [ Time Frame: From the start of treatment to 2 years ]Overall survival time is defined as time from start of treatment to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
The following primary cancer subtypes are eligible:
- Squamous cell carcinoma
- Large cell carcinoma
- Bronchoalveolar cell carcinoma
- Non-small cell carcinoma not otherwise specified
Stage I or II disease based on 1 of the following tumor node metastasis (TNM) stage criteria:
- T1, N0, M0
- T2 (≤ 5 cm), N0, M0
- T3 (≤ 5 cm), N0, M0 (chest wall primary tumors only)
- No primary tumor of any T-stage within or touching the zone of the proximal bronchial tree* NOTE: *Defined as a volume 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, and right and left lower lobe bronchi)
- No primary T3 tumors involving the central chest (≤ 2 cm toward carina invasion) or structures of the mediastinum
- Any hilar or mediastinal lymph nodes > 1 cm on CT scan OR demonstrating suspicious uptake on positron-emission tomography scan must be biopsied and confirmed negative for NSCLC
- The primary tumor must be deemed technically resectable with a reasonable possibility of obtaining a gross total resection with negative margins (defined as a potentially curative resection (PCR))
Deemed medically inoperable based on pulmonary function for surgical resection of NSCLC secondary to an underlying physiological problem, including any of the following medical conditions*:
- Baseline forced expiratory volume (FEV)_1< 40% of predicted
- Postoperative predicted FEV_1 < 30% of predicted
- Severely reduced diffusion capacity
- Baseline hypoxemia and/or hypercapnia
- Exercise oxygen consumption < 50% of predicted
- Severe pulmonary hypertension
- Diabetes mellitus with severe end organ damage
- Severe cerebral, cardiac, or peripheral vascular disease
- Severe chronic heart disease NOTE: *Patients who refuse a PCR due to preference, ideology, emotional or psychological issues, mental illness, or inability to give informed consent are not eligible
- No evidence of regional or distant metastases
- 18 and over
- Zubrod 0-2
- Not specified
- Not specified
- Not specified
- Not specified
- See Disease Characteristics
- No active pericardial infection
- See Disease Characteristics
- No active pulmonary infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active systemic infection
- No other concurrent illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
- No concurrent biologic therapy
- No concurrent vaccine therapy
- No concurrent chemotherapy
- Not specified
- No prior lung or mediastinal radiotherapy
- No concurrent standard fractionated radiotherapy
- No concurrent intensity modulated radiotherapy
- No concurrent cobalt-60 or charged particle beams (including electrons, protons, or heavier ions)
- See Disease Characteristics
- No concurrent surgery
- No other concurrent antineoplastic therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00087438
|United States, New York|
|James P. Wilmot Cancer Center at University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|United States, Texas|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Principal Investigator:||Robert D. Timmerman, MD||Simmons Cancer Center|
|Responsible Party:||Radiation Therapy Oncology Group|
|Other Study ID Numbers:||
|First Posted:||July 12, 2004 Key Record Dates|
|Results First Posted:||April 7, 2014|
|Last Update Posted:||January 16, 2019|
|Last Verified:||December 2018|
stage I non-small cell lung cancer
stage II non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
adenocarcinoma of the lung
bronchoalveolar cell lung cancer
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases