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Non-small Cell Lung CancerPhase 1/2SBF-NSCLCNCT00246181

Phase I and II Study Of Stereotactic Body Radiotherapy in Medically Unresectable Patients With Stage 1 NSCLC

A Phase 1/2 study testing radiation therapy in people with Non-small Cell Lung Cancer, run by Jill Deluca at 1 site in United States.

Completed

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

Official record
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Trial summary

This clinical trial involves a radiation treatment called stereotactic radiotherapy in non-small cell lung cancer patients who have been determined to be ineligible for surgery. This treatment differs from conventional radiotherapy in the number of treatments, the radiation dose given per treatment, and the way the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
radiation therapy
Type of treatment
Surgery or procedure
How many people
117 participants
Where
1 siteUnited States
Study dates
Dec 1999to Aug 2012
Phase
Phase 1/2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Consistent with most therapeutic oncology trials, patients are not actively "recruited," but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit.
  • All patients must be willing and capable to provide informed consent to participate in the protocol.
  • Eligible patients must have appropriate staging studies identifying them as AJCC stage I (T1 or T2, N0, M0) primary lung carcinoma. The patient should not have direct evidence of regional or distant metastases after appropriate staging studies. Histologic confirmation will be required by either biopsy or cytology. The following primary cancer types are eligible: Squamous cell carcinoma, Adenocarcinoma, Large cell carcinoma, bronchioloalveolar cell carcinoma or non-small cell; not otherwise specified.
  • The primary tumor must be deemed technically resectable by an experienced thoracic cancer clinician, with a reasonable possibility of obtaining a gross total resection with negative margins (defined as a potentially curative resection, PCR); however, the patient should have underlying physiological medical problems that would prohibit a PCR due to a low probability of tolerating general anesthesia, the operation, the post-operative recovery period, or the removal of adjacent functioning lung. Standard "cut-off " guidelines regarding surgical resection of NSCLC include the following: Baseline FEV1 <40%, post-operative predicted FEV1 <30%, severely reduced diffusion capacity, baseline hypoxemia and/or hypercapnia and exercise oxygen consumption <50% predicted.
  • Patients who refuse a PCR due to preference, ideology, emotional or psychological issues, mental illness, or inability to give consent for the PCR and who have no specific accepted medical contraindications for the PCR are not eligible.
  • Eligible patients should not have had previous lung or mediastinal radiotherapy.
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  • There must be no plans for the patient to receive other concomitant antineoplastic therapy while on this protocol. Patients who have received chemotherapy within 8 weeks of the start date of study are ineligible.
  • Patients must be able to fit inside the stereotactic body frame and able to undergo a CT or MRI scan in the frame.
  • The patient's primary tumor must not be larger than 7.0 cm in greatest dimension.
  • Patients with active systemic, pulmonary, or pericardial infection are ineligible.
  • Pregnant or lactating women are ineligible. Women/men of reproductive potential may not participate unless they agreed to use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills.
  • Patients must be past their 18th birthday at time of registration. Karnofsky performance status > 60.
  • -

Who cannot join

  • See inclusion criteria.
  • -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana University, Department of Radiation Oncology

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

This clinical trial involves a radiation treatment called stereotactic radiotherapy in non-small cell lung cancer patients who have been determined to be ineligible for surgery. This treatment differs from conventional radiotherapy in the number of treatments, the radiation dose given per treatment, and the way the radiation beams are directed toward the cancer.

Read the detailed description

The most common treatment for early stage lung cancers is to remove the cancer with surgery. Patients with serious underlying health problems like emphysema, diabetes, or heart disease who develop an early stage lung cancer may not be eligible for the standard surgical treatment. The most common alternative to surgery is conventional radiation treatment called fractionated radiotherapy. "Fractionated radiotherapy" means several weeks of treatment with daily radiation sessions. While this treatment is sometimes successful at killing the cancer, it is not as effective as surgery and may significantly damage the surrounding lung tissue.

Newer treatments using radiotherapy have been developed and used for patients with metastases (spreading cancer) to the lungs. Stereotactic radiotherapy uses a frame to guide highly focused beams of radiation at the cancer while avoiding the normal surrounding tissue. Stereotactic radiotherapy also uses a higher daily dose of radiation. The higher daily dose may be more effective than conventional radiotherapy at killing cancer cells and may also decrease side effects.

Being tested
radiation therapy
Keywords
Lung cancer, stereotactic body radiotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

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

  • radiation therapyProcedure or surgery

    Patients will receive 3 fractions

What is being measured

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

  1. The purposes of this research study are (1) to find the highest dose of stereotactic radiotherapy that can safely be used for treatment of early stage non-small cell lung cancer.

    Measured: 5 years from enrollment completion

Secondary outcomes (1)

  1. (2) to see what effects (good and bad) stereotactic radiotherapy has on patients and their cancer.

    Measured: 5 years from completion enrollment

Timeline

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

  1. First posted31 Oct 2005 (estimated)
  2. Study startDec 1999
  3. Primary completionAug 2012
  4. Study completionAug 2012

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
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00246181
Sponsor's protocol ID
9910-35
Acronym
SBF-NSCLC
Status last verified
Jan 2014
First submitted
27 Oct 2005
Last updated
13 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Henderson M, McGarry R, Yiannoutsos C, Fakiris A, Hoopes D, Williams M, Timmerman R. Baseline pulmonary function as a predictor for survival and decline in pulmonary function over time in patients undergoing stereotactic body radiotherapy for the treatment of stage I non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2008 Oct 1;72(2):404-9. doi: 10.1016/j.ijrobp.2007.12.051. Epub 2008 Apr 18.

    PubMed 18394819

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing radiation therapy in people with Non-small Cell Lung Cancer, run by Jill Deluca at 1 site in United States.

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

Who may be eligible to take part?

The sponsor lists 13 inclusion and 2 exclusion criteria. 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 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The purposes of this research study are (1) to find the highest dose of stereotactic radiotherapy that can safely be used for treatment of early stage non-small cell lung cancer. (time frame: 5 years from enrollment completion). 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 NCT00246181, which also lists 1 linked publication.

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 13 Jan 2014.

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