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NCT00087438 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2019-01-16

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Local Control at 2 Years

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outcome · POSTED

Proportion of Subjects With Specified Adverse Events

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outcome · POSTED

Rate of Local Recurrence at 2 Years

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outcome · POSTED

Rate of Regional Recurrence at 2 Years

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outcome · POSTED

Rate of Disseminated Recurrence at 2 Years

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outcome · POSTED

Rate of Disease-free Survival at 2 Years

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outcome · POSTED

Rate of Overall Survival at 2 Years

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * The following primary cancer subtypes are eligible: * Squamous cell carcinoma * Adenocarcinoma * 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 PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * See Disease Characteristics * No active pericardial infection Pulmonary * See Disease Characteristics * No active pulmonary infection Other * 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: Biologic therapy * No concurrent biologic therapy * No concurrent vaccine therapy Chemotherapy * No concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * 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) Surgery * See Disease Characteristics * No concurrent surgery Other * No other concurrent antineoplastic therapy
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy
    intervention Names
    1. Radiation: stereotactic body radiation therapy
    label
    Stereotactic body radiation therapy (SBRT)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Stereotactic body radiation therapy (SBRT)
    name
    stereotactic body radiation therapy
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
59
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Local Control at 2 Years
    time Frame
    From the start of treatment to 2 years
secondary Outcomes
  1. description
    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.
    measure
    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.
  2. description
    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).
    measure
    Rate of Local Recurrence at 2 Years
    time Frame
    From the start of treatment to 2 years
  3. description
    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.
    measure
    Rate of Regional Recurrence at 2 Years
    time Frame
    From the start of treatment to 2 years
  4. description
    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.
    measure
    Rate of Disseminated Recurrence at 2 Years
    time Frame
    From the start of treatment to 2 years
  5. description
    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.
    measure
    Rate of Disease-free Survival at 2 Years
    time Frame
    From the start of treatment to 2 years
  6. description
    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.
    measure
    Rate of Overall Survival at 2 Years
    time Frame
    From the start of treatment to 2 years
Full study description
brief Summary
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.
detailed Description
OBJECTIVES: Primary * 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. Secondary * 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.
Source references
references
  1. citation
    Hurkmans CW, Cuijpers JP, Lagerwaard FJ, Widder J, van der Heide UA, Schuring D, Senan S. Dosimetric evaluation of heterogeneity corrections for RTOG 0236: stereotactic body radiotherapy of inoperable Stage I-II non-small-cell lung cancer. In reply to Dr. Xiao et al. Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):318; author reply 318. doi: 10.1016/j.ijrobp.2009.05.050. No abstract available.
    pmid
    19695451
    type
    BACKGROUND
  2. citation
    Timmerman R, Galvin J, Michalski J, Straube W, Ibbott G, Martin E, Abdulrahman R, Swann S, Fowler J, Choy H. Accreditation and quality assurance for Radiation Therapy Oncology Group: Multicenter clinical trials using Stereotactic Body Radiation Therapy in lung cancer. Acta Oncol. 2006;45(7):779-86. doi: 10.1080/02841860600902213.
    pmid
    16982540
    type
    BACKGROUND
  3. citation
    Timmerman R, Paulus R, Galvin J, Michalski J, Straube W, Bradley J, Fakiris A, Bezjak A, Videtic G, Johnstone D, Fowler J, Gore E, Choy H. Stereotactic body radiation therapy for inoperable early stage lung cancer. JAMA. 2010 Mar 17;303(11):1070-6. doi: 10.1001/jama.2010.261.
    pmid
    20233825
    type
    RESULT
  4. citation
    Xiao Y, Papiez L, Paulus R, Timmerman R, Straube WL, Bosch WR, Michalski J, Galvin JM. Dosimetric evaluation of heterogeneity corrections for RTOG 0236: stereotactic body radiotherapy of inoperable stage I-II non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2009 Mar 15;73(4):1235-42. doi: 10.1016/j.ijrobp.2008.11.019.
    pmid
    19251095
    type
    RESULT
  5. citation
    Timmerman RD, Paulus R, Galvin J, et al.: Toxicity analysis of RTOG 0236 using stereotactic body radiation therapy to treat medically inoperable early stage lung cancer patients. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-151, S86, 2007.
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        rachea to the level of the lobar bronchi).[<a href="#cit/section_7.31">31</a>]</li></ul></div></li><li>A subsequent multicenter trial (<a href="/clinicaltrials/NCT00087438">RTOG-0236</a> [NCT00087438]) studied the 18 Gy &#215; 3 regimen in 55 patients with peripheral T1 to T2 tumors only.<div class="pdq-content-list"><ul id="_484
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        obar bronchi).[<a href="#cit/section_7.31">31</a>]</li></ul></div></li><li>A subsequent multicenter trial (<a href="/clinicaltrials/NCT00087438">RTOG-0236</a> [NCT00087438]) studied the 18 Gy &#215; 3 regimen in 55 patients with peripheral T1 to T2 tumors only.<div class="pdq-content-list"><ul id="_484638"><li>This trial demonstr
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      source update dates
      1. context
        Updated: May 15, 2025
        datetime
        2025-05-15T12:00:00Z
        display
        May 15, 2025

    Preserved source evidence · Not medical advice