Lung CancerPhase 2NCT00843726
Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
A Phase 2 study testing Arm 1 stereotactic body radiation therapy and Arm II stereotactic body radiation therapy in people with Lung Cancer, run by Roswell Park Cancer Institute at 3 sites in United States.
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. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer. 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?
- Arm 1 stereotactic body radiation therapy and Arm II stereotactic body radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Sep 2008to 6 May 2020
- Phase
- Phase 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
Who may be able to join
- Histologically confirmed non-small cell lung cancer
- T1-T2, N0 disease measuring ≤ 5 cm( T3 tumor based on chest wall involvement is Excluded)
- Surgically resectable primary disease, however patient evaluated by thoracic oncologist and deemed medically inoperable OR patient refuses surgical resection
- Age >= 18
Who cannot join
- Prior thoracic radiation therapy
- T2 or T3 tumor greater than 5 cm or T3 tumor based on chest wall involvement
- Node positive or metastatic disease
- Tumor location within the zone of the proximal bronchial tree. The proximal bronchial tree is defined as the carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi. The zone of the proximal bronchial tree is defined as a volume 2cm in all directions around the proximal bronchial tree.
- No other conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly)
- Pregnant or unwilling to use adequate contraception
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Cleveland Clinic
Cleveland, Ohio, 44195
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: A Phase II Randomized Study of 2 Stereotactic Body Radiation Therapy (SBRT) Regimens for Medically Inoperable Patients With Node Negative, Peripheral Non-Small Cell Lung Cancer
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I or stage II non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- To compare the incidence of toxicity with two established stereotactic body radiotherapy (SBRT) regimens in patients with node-negative, peripheral stage I or II non-small cell lung cancer.
Secondary
- To compare quality of life, patterns of failure, disease-free survival, and overall survival of these patients after treatment with one of two established SBRT regimens.
- To correlate outcomes and toxicities with imaging and patient and tumor biomarkers.
OUTLINE: Patients are stratified according to Karnofsky performance status and treatment center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
- Arm II: Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
Quality of life is assessed periodically by the EORTC QLQ-C30 and -LC13 questionnaires
Blood and tissue samples may be collected periodically and examined for biomarkers via ELISA and immunoblotting.
After completion of study treatment, patients are followed for 5 years.
- Conditions
- Lung Cancer
- Being tested
- Arm 1 stereotactic body radiation therapy, Arm II stereotactic body radiation therapy
- Keywords
- stage I non-small cell lung cancer, stage II 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.
Arm 1 stereotactic body radiation therapyRadiation
Patients undergo 1 high-dose fraction
Arm II stereotactic body radiation therapyRadiation
Patients undergo 3 high-dose fractions
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). Receives: Radiation: Arm 1 stereotactic body radiation therapy |
| Arm II | Experimental | Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT. Receives: Radiation: Arm II stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AE Grade 3 or Higher Toxicity
Count of patients experiencing at least one grade 3 or higher adverse event. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is used for assessing the adverse events. High grades AEs are considered worse.
Measured: 1year
Overall Survival
Median overall survival
Measured: 5 years
Correlation Between Blood and Serum Markers and Survival and Toxicity
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study start12 Sep 2008
- Primary completion6 May 2020
- Study completion6 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anurag K. Singh, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843726
- Sponsor's protocol ID
- I 124407
- Other IDs
- I 124407
- Status last verified
- May 2021
- First submitted
- 12 Feb 2009
- Last updated
- 15 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of 2 Stereotactic Body Radiation Therapy (SBRT) Regimens for Medically Inoperable Patients With Node Negative, Peripheral Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00843726
- Acronym / sponsor ID
- I 124407
- Conditions
- Lung Cancer
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 12 Sep 2008 (actual)
- Primary completion
- 6 May 2020 (actual)
- Study completion
- 6 May 2020 (actual)
- First posted
- 13 Feb 2009 (estimated)
- Results
- Posted 15 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I or stage II non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- To compare the incidence of toxicity with two established stereotactic body radiotherapy (SBRT) regimens in patients with node-negative, peripheral stage I or II non-small cell lung cancer.
Secondary
- To compare quality of life, patterns of failure, disease-free survival, and overall survival of these patients after treatment with one of two established SBRT regimens.
- To correlate outcomes and toxicities with imaging and patient and tumor biomarkers.
OUTLINE: Patients are stratified according to Karnofsky performance status and treatment center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
- Arm II: Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
Quality of life is assessed periodically by the EORTC QLQ-C30 and -LC13 questionnaires
Blood and tissue samples may be collected periodically and examined for biomarkers via ELISA and immunoblotting.
After completion of study treatment, patients are followed for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Radiation: Arm 1 stereotactic body radiation therapyPatients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). |
| Arm II | Experimental | Radiation: Arm II stereotactic body radiation therapyPatients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed non-small cell lung cancer
- T1-T2, N0 disease measuring ≤ 5 cm( T3 tumor based on chest wall involvement is Excluded)
- Surgically resectable primary disease, however patient evaluated by thoracic oncologist and deemed medically inoperable OR patient refuses surgical resection
- Age >= 18
Key exclusion criteria (6 listed)
- Prior thoracic radiation therapy
- T2 or T3 tumor greater than 5 cm or T3 tumor based on chest wall involvement
- Node positive or metastatic disease
- Tumor location within the zone of the proximal bronchial tree. The proximal bronchial tree is defined as the carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi. The zone of the proximal bronchial tree is defined as a volume 2cm in all directions around the proximal bronchial tree.
- No other conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1 stereotactic body radiation therapyPatients undergo 1 high-dose fraction | Radiation | Arm I |
| Arm II stereotactic body radiation therapyPatients undergo 3 high-dose fractions | Radiation | Arm II |
Primary outcome
Incidence of AE Grade 3 or Higher Toxicity
Time frame: 1year
Count of patients experiencing at least one grade 3 or higher adverse event. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is used for assessing the adverse events. High grades AEs are considered worse.
Overall Survival
Time frame: 5 years
Median overall survival
Correlation Between Blood and Serum Markers and Survival and Toxicity
Time frame: 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anurag K. Singh, MD principal investigator
Roswell Park Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arm 1 stereotactic body radiation therapy and Arm II stereotactic body radiation therapy in people with Lung Cancer, run by Roswell Park Cancer Institute at 3 sites 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 4 inclusion and 6 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 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 phase mean?
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 15 Jun 2021). 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?
Incidence of AE Grade 3 or Higher Toxicity (time frame: 1year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2021.