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NCT00750269 · CITED IN SOURCE DOCUMENTS

Stereotactic Body Radiation Therapy in Treating Patients With Stage I 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
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2022-06-09

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.

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

(Phase I) Maximum Tolerated Dose of Stereotactic Body Radiotherapy (SBRT) as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0

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outcome · POSTED

(Phase II) Primary Tumor Control Rate at the Maximum Tolerated Dose (MTD)

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

Local Progression

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outcome · POSTED

Nodal Progression

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outcome · POSTED

Distant Metastases

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outcome · POSTED

Rate of Toxicity ≥ Grade 3 (Other Than DLT) Within One Year as Assessed by NCI CTCAE v4.0

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outcome · POSTED

Rate of Late Toxicity (i.e., Occurs > 1 Year After the Start of SBRT) of ≥ Grade 3 as Assessed by NCI CTCAE v4.0

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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) * Stage T1-2, N0, M0 disease * Tumor size ≤ 5 cm * 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 positron emission tomography (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 PATIENT CHARACTERISTICS: * Zubrod performance status 0-2 * Not pregnant * Negative pregnancy test * 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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    SBRT 40.0 Gy
    intervention Names
    1. Radiation: SBRT 40.0 Gy
    label
    Level 1: 8.0 Gy/FX
    type
    EXPERIMENTAL
  2. description
    SBRT 42.5 Gy
    intervention Names
    1. Radiation: SBRT 42.5 Gy
    label
    Level 2: 8.5 Gy/FX
    type
    EXPERIMENTAL
  3. description
    SBRT 45.0 Gy
    intervention Names
    1. Radiation: SBRT 45.0 Gy
    label
    Level 3: 9.0 Gy/FX
    type
    EXPERIMENTAL
  4. description
    SBRT 47.5 Gy
    intervention Names
    1. Radiation: SBRT 47.5 Gy
    label
    Level 4: 9.5 Gy/FX
    type
    EXPERIMENTAL
  5. description
    SBRT 50.0 Gy
    intervention Names
    1. Radiation: SBRT 50.0 Gy
    label
    Level 5: 10.0 Gy/FX
    type
    EXPERIMENTAL
  6. description
    SBRT 52.5 Gy
    intervention Names
    1. Radiation: SBRT 52.5 Gy
    label
    Level 6: 10.5 Gy/FX
    type
    EXPERIMENTAL
  7. description
    SBRT 55.0 Gy
    intervention Names
    1. Radiation: SBRT 55.0 Gy
    label
    Level 7: 11.0 Gy/FX
    type
    EXPERIMENTAL
  8. description
    SBRT 57.5 Gy
    intervention Names
    1. Radiation: SBRT 57.5 Gy
    label
    Level 8: 11.5 Gy/FX
    type
    EXPERIMENTAL
  9. description
    SBRT 60.0 Gy
    intervention Names
    1. Radiation: SBRT 60.0 Gy
    label
    Level 9: 12.0 Gy/FX
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Level 1: 8.0 Gy/FX
    description
    SBRT delivered in 5 fractions of 8.0 Gy/fraction over 1.5 to 2 weeks for a total of 40.0 Gy
    name
    SBRT 40.0 Gy
    other Names
    1. Stereotactic body radiation therapy (SBRT)
    2. Stereotactic ablative radiotherapy (SABR)
    type
    RADIATION
  2. arm Group Labels
    1. Level 2: 8.5 Gy/FX
    description
    SBRT delivered in 5 fractions of 8.5 Gy/fraction over 1.5 to 2 weeks for a total of 42.5 Gy
    name
    SBRT 42.5 Gy
    other Names
    1. Stereotactic body radiation therapy (SBRT)
    2. Stereotactic ablative radiotherapy (SABR)
    type
    RADIATION
  3. arm Group Labels
    1. Level 3: 9.0 Gy/FX
    description
    SBRT delivered in 5 fractions of 9.0 Gy/fraction over 1.5 to 2 weeks for a total of 45.0 Gy
    name
    SBRT 45.0 Gy
    other Names
    1. Stereotactic body radiation therapy (SBRT)
    2. Stereotactic ablative radiotherapy (SABR)
    type
    RADIATION
  4. arm Group Labels
    1. Level 4: 9.5 Gy/FX
    description
    SBRT delivered in 5 fractions of 9.5 Gy/fraction over 1.5 to 2 weeks for a total of 47.5 Gy
    name
    SBRT 47.5 Gy
    other Names
    1. Stereotactic body radiation therapy (SBRT)
    2. Stereotactic ablative radiotherapy (SABR)
    type
    RADIATION
  5. arm Group Labels
    1. Level 5: 10.0 Gy/FX
    description
    SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
    name
    SBRT 50.0 Gy
    other Names
    1. Stereotactic body radiation therapy (SBRT)
    2. Stereotactic ablative radiotherapy (SABR)
    type
    RADIATION
  6. arm Group Labels
    1. Level 6: 10.5 Gy/FX
    description
    SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
    name
    SBRT 52.5 Gy
    other Names
    1. Stereotactic body radiation therapy (SBRT)
    2. Stereotactic ablative radiotherapy (SABR)
    type
    RADIATION
  7. arm Group Labels
    1. Level 7: 11.0 Gy/FX
    description
    SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
    name
    SBRT 55.0 Gy
    other Names
    1. Stereotactic body radiation therapy (SBRT)
    2. Stereotactic ablative radiotherapy (SABR)
    type
    RADIATION
  8. arm Group Labels
    1. Level 8: 11.5 Gy/FX
    description
    SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy
    name
    SBRT 57.5 Gy
    other Names
    1. Stereotactic body radiation therapy (SBRT)
    2. Stereotactic ablative radiotherapy (SABR)
    type
    RADIATION
  9. arm Group Labels
    1. Level 9: 12.0 Gy/FX
    description
    SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy
    name
    SBRT 60.0 Gy
    other Names
    1. Stereotactic body radiation therapy (SBRT)
    2. Stereotactic ablative radiotherapy (SABR)
    type
    RADIATION
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
120
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Maximum tolerated dose (MTD) defined as dose most closely associated with a 20% probability of experiencing a toxicity \<= 1 year from start of SBRT from following dose-limiting toxicities: Gr 3-5 Cardiac: Pericardial effusion, Pericarditis, Restrictive cardiomyopathy; Gr 4-5 GI: Dysphagia, Esophagitis, Esophageal fistula/obstruction/perforation/stenosis/ulcer/hemorrhage; Gr 3-5 Nervous System Disorders: Brachial plexopathy, Recurrent laryngeal nerve palsy, Myelitis; Gr 3-5 Respiratory: Atelectasis (gr 4-5 only), Bronchopulmonary/mediastinal/pleural/tracheal hemorrhage, Bronchial/pulmonary/bronchopleural/tracheal fistula, Hypoxia (provided gr 3 is worse than baseline), Bronchial/tracheal obstruction, Pleural effusion, Pneumonitis, Pulmonary fibrosis; Changes in Pulmonary Function Tests per SBRT Pulmonary Toxicity Scale, Gr 3-5: FEV1 decline, FVC decline; Any Gr 5 adverse event attributed to treatment. Dose level was determined by time-to-event continual reassessment method (TITE-CRM).
    measure
    (Phase I) Maximum Tolerated Dose of Stereotactic Body Radiotherapy (SBRT) as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0
    time Frame
    From start of SBRT to 1 year
  2. description
    Primary tumor control is defined as the absence of primary tumor failure. Primary tumor failure (PTF) refers to the primary treated tumor after protocol therapy and corresponds to meeting following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. Marginal Failures (MF) and Involved Lobe Failures were also counted as PTF. The cumulative incidence method was used to estimate primary tumor control rate. The 90% confidence interval for local control was calculated using bootstrapping methods. Per the protocol, only the MTD dose level was to be analyzed. However, due to the quantity of patients enrolled on Dose Level 8 as well as safety concerns, Dose Level 8 was analyzed also.
    measure
    (Phase II) Primary Tumor Control Rate at the Maximum Tolerated Dose (MTD)
    time Frame
    From start of SBRT to 2 years.
secondary Outcomes
  1. description
    Progression-free survival is defined as the state of being alive without progression of disease. A failure is the first of the following: local progression, regional progression, distant metastasis, or death. Progression-free survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.
    measure
    Progression-free Survival
    time Frame
    From randomization to date of death, failure (local, regional or distant) or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.
  2. description
    An event for overall survival is death due to any cause. Overall survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.
    measure
    Overall Survival
    time Frame
    From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.
  3. description
    Local progression is the same as primary tumor failure (PTF) which refers to the primary treated tumor after protocol therapy and corresponds to meeting both of the following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. For outcome analysis, Marginal Failures (MF) and Involved Lobe Failures will also be counted as PTF. Local progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.
    measure
    Local Progression
    time Frame
    From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months.
  4. description
    Regional nodal progression is defined as appearance after protocol therapy of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably CT scans) within the lung, bronchial hilum, or the mediastinum. Regional nodal progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.
    measure
    Nodal Progression
    time Frame
    From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.
  5. description
    Distant metastases is defined as the appearance after protocol therapy of cancer deposits characteristic of metastatic dissemination from non-small cell lung cancer. Distant metastases progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.
    measure
    Distant Metastases
    time Frame
    From randomization to date of death, distant failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.
  6. description
    Rate of patients developing any treatment-related toxicity during the first year following the start of SBRT that is not among the types considered as a dose-limiting toxicity.
    measure
    Rate of Toxicity ≥ Grade 3 (Other Than DLT) Within One Year as Assessed by NCI CTCAE v4.0
    time Frame
    From start of SBRT until 1 year.
  7. description
    Percentage of patients who developed any treatment-related toxicity after the first year following the start of SBRT.
    measure
    Rate of Late Toxicity (i.e., Occurs > 1 Year After the Start of SBRT) of ≥ Grade 3 as Assessed by NCI CTCAE v4.0
    time Frame
    From start of treatment to end of follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.
Full study description
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 non-small cell lung cancer.
detailed Description
OBJECTIVES: Primary * 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 estimate the local control rate of SBRT at the MTD in these patients. (Phase II) Secondary * 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 \[total of 5 fractions (FX)\] in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 3 months for 2 years, then every 6 months for 2 years, then annually.
Source references
references
  1. citation
    Bezjak A, Paulus R, Gaspar LE, Timmerman RD, Straube WL, Ryan WF, Garces YI, Pu AT, Singh AK, Videtic GM, McGarry RC, Iyengar P, Pantarotto JR, Urbanic JJ, Sun AY, Daly ME, Grills IS, Sperduto P, Normolle DP, Bradley JD, Choy H. Safety and Efficacy of a Five-Fraction Stereotactic Body Radiotherapy Schedule for Centrally Located Non-Small-Cell Lung Cancer: NRG Oncology/RTOG 0813 Trial. J Clin Oncol. 2019 May 20;37(15):1316-1325. doi: 10.1200/JCO.18.00622. Epub 2019 Apr 3.
    pmid
    30943123
    type
    DERIVED
  2. citation
    Levy A, Guckenberger M, Hurkmans C, Nestle U, Belderbos J, De Ruysscher D, Faivre-Finn C, Le Pechoux C. SBRT Dose and Survival in Non-Small Cell Lung Cancer: In Regard to Koshy et al. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):945-6. doi: 10.1016/j.ijrobp.2015.03.032. No abstract available.
    pmid
    26104945
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        protracted SBRT regimens (e.g., four to ten fractions).[<a href="#cit/section_7.37">37</a>] </li><li>A multicenter phase I/II trial (<a href="/clinicaltrials/NCT00750269">RTOG-0813</a> [NCT00750269]) is ongoing to identify the maximum tolerated dose for a five-fraction SBRT regimen for central tumors. </li></ol></div>
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      2. context exact
        .g., four to ten fractions).[<a href="#cit/section_7.37">37</a>] </li><li>A multicenter phase I/II trial (<a href="/clinicaltrials/NCT00750269">RTOG-0813</a> [NCT00750269]) is ongoing to identify the maximum tolerated dose for a five-fraction SBRT regimen for central tumors. </li></ol></div> <p id="_484640" tabindex="-
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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