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Lung CancerPhase 1/2NCT00750269

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

A Phase 1/2 study testing SBRT 40.0 Gy, SBRT 42.5 Gy and SBRT 45.0 Gy in people with Lung Cancer, run by Radiation Therapy Oncology Group at 58 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lung Cancer
What is being tested?
SBRT 40.0 Gy, SBRT 42.5 Gy and SBRT 45.0 Gy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
58 sitesin 2 countries
Study dates
Feb 2009to 20 May 2022
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

58 sites in 2 countries.

58 sites in 2 countries

United States57 sites

  • Rosenfeld Cancer Center at Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • Tulane Cancer Center Office of Clinical Research

    Alexandria, Louisiana, 71315-3198

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

    Burbank, California, 91505

  • Radiation Oncology Centers - Cameron Park

    Cameron Park, California, 95682

  • Mercy Cancer Center at Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210-1240

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Dale and Frances Hughes Cancer Center at Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • McLaren Cancer Institute

    Flint, Michigan, 48532

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Norton Suburban Hospital

    Louisville, Kentucky, 40207

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee

    Milwaukee, Wisconsin, 53295

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Cooper CyberKnife Center

    Mount Laurel, New Jersey, 08054

  • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

    New Britain, Connecticut, 06050

  • St. Luke's - Roosevelt Hospital Center - St.Luke's Division

    New York, New York, 10025

  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

    New York, New York, 10032

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Sentara Cancer Institute at Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • M.D. Anderson Cancer Center at Orlando

    Orlando, Florida, 32806

  • Arizona Center for Cancer Care - Peoria

    Peoria, Arizona, 85381

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Frankford Hospital Cancer Center - Torresdale Campus

    Philadelphia, Pennsylvania, 19114

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • CCOP - Kansas City

    Prairie Village, Kansas, 66208

  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Maine Center for Cancer Medicine and Blood Disorders - Scarborough

    Scarborough, Maine, 04074

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195

  • Frederick R. and Betty M. Smith Cancer Treatment Center

    Sparta, New Jersey, 07871

  • Saint Louis University Cancer Center

    St Louis, Missouri, 63110

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Canada1 site

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients

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.

Read the 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.

Conditions
Lung Cancer
Being tested
SBRT 40.0 Gy, SBRT 42.5 Gy, SBRT 45.0 Gy, SBRT 47.5 Gy, SBRT 50.0 Gy
Keywords
stage I non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBRT 40.0 GyRadiation

    Also called Stereotactic body radiation therapy (SBRT), Stereotactic ablative radiotherapy (SABR)

    SBRT delivered in 5 fractions of 8.0 Gy/fraction over 1.5 to 2 weeks for a total of 40.0 Gy

  • SBRT 42.5 GyRadiation

    Also called Stereotactic body radiation therapy (SBRT), Stereotactic ablative radiotherapy (SABR)

    SBRT delivered in 5 fractions of 8.5 Gy/fraction over 1.5 to 2 weeks for a total of 42.5 Gy

  • SBRT 45.0 GyRadiation

    Also called Stereotactic body radiation therapy (SBRT), Stereotactic ablative radiotherapy (SABR)

    SBRT delivered in 5 fractions of 9.0 Gy/fraction over 1.5 to 2 weeks for a total of 45.0 Gy

  • SBRT 47.5 GyRadiation

    Also called Stereotactic body radiation therapy (SBRT), Stereotactic ablative radiotherapy (SABR)

    SBRT delivered in 5 fractions of 9.5 Gy/fraction over 1.5 to 2 weeks for a total of 47.5 Gy

  • SBRT 50.0 GyRadiation

    Also called Stereotactic body radiation therapy (SBRT), Stereotactic ablative radiotherapy (SABR)

    SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy

  • SBRT 52.5 GyRadiation

    Also called Stereotactic body radiation therapy (SBRT), Stereotactic ablative radiotherapy (SABR)

    SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy

  • SBRT 55.0 GyRadiation

    Also called Stereotactic body radiation therapy (SBRT), Stereotactic ablative radiotherapy (SABR)

    SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy

  • SBRT 57.5 GyRadiation

    Also called Stereotactic body radiation therapy (SBRT), Stereotactic ablative radiotherapy (SABR)

    SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy

  • SBRT 60.0 GyRadiation

    Also called Stereotactic body radiation therapy (SBRT), Stereotactic ablative radiotherapy (SABR)

    SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy

Study groups in NCT00750269
Study groupRoleWhat they receive
Level 1: 8.0 Gy/FXExperimentalSBRT 40.0 Gy
Receives: Radiation: SBRT 40.0 Gy
Level 2: 8.5 Gy/FXExperimentalSBRT 42.5 Gy
Receives: Radiation: SBRT 42.5 Gy
Level 3: 9.0 Gy/FXExperimentalSBRT 45.0 Gy
Receives: Radiation: SBRT 45.0 Gy
Level 4: 9.5 Gy/FXExperimentalSBRT 47.5 Gy
Receives: Radiation: SBRT 47.5 Gy
Level 5: 10.0 Gy/FXExperimentalSBRT 50.0 Gy
Receives: Radiation: SBRT 50.0 Gy
Level 6: 10.5 Gy/FXExperimentalSBRT 52.5 Gy
Receives: Radiation: SBRT 52.5 Gy
Level 7: 11.0 Gy/FXExperimentalSBRT 55.0 Gy
Receives: Radiation: SBRT 55.0 Gy
Level 8: 11.5 Gy/FXExperimentalSBRT 57.5 Gy
Receives: Radiation: SBRT 57.5 Gy
Level 9: 12.0 Gy/FXExperimentalSBRT 60.0 Gy
Receives: Radiation: SBRT 60.0 Gy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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).

    Measured: From start of SBRT to 1 year

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

    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.

    Measured: From start of SBRT to 2 years.

Secondary outcomes (7)

  1. Progression-free Survival

    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.

    Measured: 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. Overall Survival

    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.

    Measured: 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. Local Progression

    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.

    Measured: 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. Nodal Progression

    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.

    Measured: 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. Distant Metastases

    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.

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

    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.

    Measured: From start of SBRT until 1 year.

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

    Percentage of patients who developed any treatment-related toxicity after the first year following the start of SBRT.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2008 (estimated)
  2. Study startFeb 2009
  3. Primary completionSep 2014
  4. Study completion20 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00750269
Sponsor's protocol ID
RTOG-0813
Other IDs
CDR0000613524, NCI-2009-01095
Status last verified
May 2022
First submitted
9 Sep 2008
Last updated
9 Jun 2022
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30943123

  • 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.

    PubMed 26104945

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SBRT 40.0 Gy, SBRT 42.5 Gy and SBRT 45.0 Gy in people with Lung Cancer, run by Radiation Therapy Oncology Group at 58 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00750269, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.

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