NSCLCNCT01237171
A Study of Cesium-131 Brachytherapy Following Sub-Lobar Resection for Early Stage Non Small Cell Lung Cancer
An observational study of NSCLC and Non Small Cell Lung Cancer, run by IsoRay Medical, Inc. at 1 site in United States.
Trial summary
For patients diagnosed with early (Stage I) non-small cell lung cancer, a lobe of lung is usually removed at surgery to treat the cancer. For some patients, the removal of a lobe of lung may leave too little lung behind for easy breathing. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- NSCLC, Non Small Cell Lung Cancer
- What is being tested?
- Cesium-131 Brachytherapy Seed
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Nov 2010
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with clinical stage I non-small cell lung cancer who are not candidates for full lobectomy.
Who may be able to join
- Patients must have suspicious lung nodule for clinical stage I/recurrent non-small cell Lung Cancer
- Mass Tumor size < 7 cm
- Patient must have a CT scan of the chest with upper abdomen within 90 days prior to date of pre-registration.
- Patient must have ECOG/Zubrod performance status 0,1, or 2.
Who cannot join
- Patient has already received high dose radiation to the area
- Cancerous nodule is very close to the esophagus or spinal cord, thereby increasing the risk of radiation treatment
- Pregnancy or unwillingness to practice a form of birth control (i.e. abstinence, oral contraceptives, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: Outcome Study of Cesium-131 Brachytherapy Following Sub-Lobar Resection for Early Stage NSCLC
For patients diagnosed with early (Stage I) non-small cell lung cancer, a lobe of lung is usually removed at surgery to treat the cancer. For some patients, the removal of a lobe of lung may leave too little lung behind for easy breathing. For some of these patients, it may be possible to perform a smaller-scale surgery ("sub-lobar resection") and place a radioactive implant behind to prevent the cancer from growing back. This study will see how these patients do in terms of controlling their disease treated with a radioactive implant called Cesium-131.
- Conditions
- NSCLC, Non Small Cell Lung Cancer
- Being tested
- Cesium-131 Brachytherapy Seed
- Keywords
- Brachytherapy, Lung Brachytherapy, NSCLC, Sub-lobar resection
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesium-131 Brachytherapy SeedRadiation
Also called Sealed Brachytherapy Source CS-1 (IsoRay Medical)
85 Gray Dose
| Study group | Role | What they receive |
|---|---|---|
| Sub-lobar resection with Cesium-131 | All enrolled patients will undergo sub-lobar resection and brachytherapy implant with Cesium-131 in an effort to study and quantify recurrence/control patterns. Receives: Radiation: Cesium-131 Brachytherapy Seed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Recurrence
Cancer regrowth in the area where it was surgically removed
Measured: 3 Years
Secondary outcomes (1)
Quality of Life
Using questionnaires, data will be collected related to the sense of well-being experienced by the patient after treatment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startNov 2010 (estimated)
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Study never moved past ideation phase
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IsoRay Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bhupesh Parashar, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237171
- Sponsor's protocol ID
- Cs131-Lung001
- Status last verified
- Mar 2021
- First submitted
- 5 Nov 2010
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Study of Cesium-131 Brachytherapy Following Sub-Lobar Resection for Early Stage NSCLC
- ClinicalTrials.gov ID
- NCT01237171
- Acronym / sponsor ID
- Cs131-Lung001
- Conditions
- NSCLC, Non Small Cell Lung Cancer
- Keywords
- Brachytherapy, Lung Brachytherapy, NSCLC, Sub-lobar resection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study never moved past ideation phase
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IsoRay Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010 (estimated)
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For patients diagnosed with early (Stage I) non-small cell lung cancer, a lobe of lung is usually removed at surgery to treat the cancer. For some patients, the removal of a lobe of lung may leave too little lung behind for easy breathing. For some of these patients, it may be possible to perform a smaller-scale surgery ("sub-lobar resection") and place a radioactive implant behind to prevent the cancer from growing back. This study will see how these patients do in terms of controlling their disease treated with a radioactive implant called Cesium-131.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sub-lobar resection with Cesium-131 | – | Radiation: Cesium-131 Brachytherapy SeedAll enrolled patients will undergo sub-lobar resection and brachytherapy implant with Cesium-131 in an effort to study and quantify recurrence/control patterns. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with clinical stage I non-small cell lung cancer who are not candidates for full lobectomy.
Key inclusion criteria (4 listed)
- Patients must have suspicious lung nodule for clinical stage I/recurrent non-small cell Lung Cancer
- Mass Tumor size < 7 cm
- Patient must have a CT scan of the chest with upper abdomen within 90 days prior to date of pre-registration.
- Patient must have ECOG/Zubrod performance status 0,1, or 2.
Key exclusion criteria (3 listed)
- Patient has already received high dose radiation to the area
- Cancerous nodule is very close to the esophagus or spinal cord, thereby increasing the risk of radiation treatment
- Pregnancy or unwillingness to practice a form of birth control (i.e. abstinence, oral contraceptives, etc.)
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 |
|---|---|---|
| Cesium-131 Brachytherapy SeedAlso: Sealed Brachytherapy Source CS-1 (IsoRay Medical)85 Gray Dose | Radiation | Sub-lobar resection with Cesium-131 |
Primary outcome
Local Recurrence
Time frame: 3 Years
Cancer regrowth in the area where it was surgically removed
1 secondary outcome
Quality of Life
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
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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.
Bhupesh Parashar, M.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC and Non Small Cell Lung Cancer, run by IsoRay Medical, Inc. 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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 30 Mar 2021. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Local Recurrence (time frame: 3 Years). 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 30 Mar 2021.