Lung NeoplasmsNCT00351962
Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable NSCLC or Metastatic Lung Tumours
A study testing Fractionated Stereotactic Radiotherapy in people with Lung Neoplasms and Lung Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
Medically inoperable lung cancer or metastatic lung tumours will be treated with fractionated stereotactic radiation using a schedule of 1) 12 Gy x 4 treatments or 2) 6 Gy x 10 treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Lung Cancer
- What is being tested?
- Fractionated Stereotactic Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to 2 Jul 2014
- Phase
- Interventional
- 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
- non-small cell lung cancer less than 6cm; no mediastinal or distant metastases
- Open to Alberta,Canada Residents
Who cannot join
- tumour size greater than 6cm; inadequate pulmonary function(ie. FEV1 less than 0.8 L), Karnofsky performance status less than 70, multiple co-morbid conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Non-Small Cell Lung Cancer (NSCLC) or Metastatic Lung Tumours
Medically inoperable lung cancer or metastatic lung tumours will be treated with fractionated stereotactic radiation using a schedule of 1) 12 Gy x 4 treatments or 2) 6 Gy x 10 treatments.
Read the detailed description
You will be positioned in a special body mould while you are lying in the treatment position. This ensures that you are treated in the exact position each time. A soft plastic sheet may be placed over your body from the chest down. A vacuum device may be used to apply the sheet gently over you. This mild compression will ensure that you can breathe comfortably but will minimize any movement which may affect the accuracy of your treatments.
A CT (computed tomography) scan will be done for your treatment planning. The CT scan will take approximately 45 minutes. In some cases, intravenous dye may be administered during the CT scan. You will be asked to hold your breath for a short time during the CT scan. If you are unable to hold your breath comfortably, the scan will be performed during your normal breathing cycle. In some cases, your doctor may also order a PET (positron emission tomography) scan. The treatment planning to be done by your oncologist and physicist will take approximately one to two weeks. After that is completed, your treatments will begin. Each treatment will take about 30 minutes.
If the CT scans show that there is a lot of movement of your lung cancer due to breathing motion, your oncologist may recommend the insertion of a "fiducial" marker to help guide your treatments. An additional consent form will be obtained prior to this procedure. The "fiducial" marker is a tiny gold or stainless steel coil measuring about one inch long. It would be inserted into your lung in or next to the tumour by a respirologist via bronchoscopy under sedation. The procedure would take approximately 30 minutes, and you would be in hospital for about 4 hours. You would meet the respirologist in the clinic in consultation prior to the procedure so that he/she can tell you more about the procedure and assess your case in details to determine if it is safe for you to undergo the procedure. The insertion of the fiducial marker is considered part of your clinical care and a separate consent will be required prior to this procedure. You may choose not to undergo this procedure but still participate in this study. In some cases, your respirologist may have already inserted a fiducial marker at the time of diagnostic bronchoscopy after discussions with yourself and your radiation oncologist. The "fiducial" marker would be used to guide your radiation treatments during your normal breathing cycle.
You will be assigned into one of the two study groups described below depending on the location of your tumour:
Schedule I (10 fractions): You will receive a total of 10 stereotactic radiation treatments, given over 3 weeks.
Schedule II (4 fractions): You will receive a total of 4 stereotactic radiation treatments, given over 2 weeks.
- Conditions
- Lung Neoplasms, Lung Cancer
- Being tested
- Fractionated Stereotactic Radiotherapy
- Keywords
- lung neoplasms, metastatic lung cancer, stereotactic radiation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractionated Stereotactic RadiotherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Schedule I (10 fractions) | Experimental | Subjects will receive a total of 10 stereotactic radiation treatments, given over 3 weeks. Receives: Procedure: Fractionated Stereotactic Radiotherapy |
| Schedule II (4 fractions) | Experimental | Subjects will receive a total of 4 stereotactic radiation treatments, given over 2 weeks. Receives: Procedure: Fractionated Stereotactic Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity as defined by CTCAE V3 grade 4 or 5.
Each schedule will be evaluated according to the occurrence of DLTs observed.
Measured: At the completion of accrual, an analysis with respect to acute toxicity will be performed after all patients have been followed a minimum of 90 days from the start of RT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2006 (estimated)
- Study startSep 2006
- Primary completionJul 2014
- Study completion2 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harold P Lau, MD, Principal investigator, Tom Baker Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351962
- Sponsor's protocol ID
- 20131
- Status last verified
- Jul 2013
- First submitted
- 11 Jul 2006
- Last updated
- 21 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Non-Small Cell Lung Cancer (NSCLC) or Metastatic Lung Tumours
- ClinicalTrials.gov ID
- NCT00351962
- Acronym / sponsor ID
- 20131
- Conditions
- Lung Neoplasms, Lung Cancer
- Keywords
- lung neoplasms, metastatic lung cancer, stereotactic radiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- Sep 2006 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- 2 Jul 2014 (actual)
- First posted
- 13 Jul 2006 (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.
Medically inoperable lung cancer or metastatic lung tumours will be treated with fractionated stereotactic radiation using a schedule of 1) 12 Gy x 4 treatments or 2) 6 Gy x 10 treatments.
Detailed description
You will be positioned in a special body mould while you are lying in the treatment position. This ensures that you are treated in the exact position each time. A soft plastic sheet may be placed over your body from the chest down. A vacuum device may be used to apply the sheet gently over you. This mild compression will ensure that you can breathe comfortably but will minimize any movement which may affect the accuracy of your treatments.
A CT (computed tomography) scan will be done for your treatment planning. The CT scan will take approximately 45 minutes. In some cases, intravenous dye may be administered during the CT scan. You will be asked to hold your breath for a short time during the CT scan. If you are unable to hold your breath comfortably, the scan will be performed during your normal breathing cycle. In some cases, your doctor may also order a PET (positron emission tomography) scan. The treatment planning to be done by your oncologist and physicist will take approximately one to two weeks. After that is completed, your treatments will begin. Each treatment will take about 30 minutes.
If the CT scans show that there is a lot of movement of your lung cancer due to breathing motion, your oncologist may recommend the insertion of a "fiducial" marker to help guide your treatments. An additional consent form will be obtained prior to this procedure. The "fiducial" marker is a tiny gold or stainless steel coil measuring about one inch long. It would be inserted into your lung in or next to the tumour by a respirologist via bronchoscopy under sedation. The procedure would take approximately 30 minutes, and you would be in hospital for about 4 hours. You would meet the respirologist in the clinic in consultation prior to the procedure so that he/she can tell you more about the procedure and assess your case in details to determine if it is safe for you to undergo the procedure. The insertion of the fiducial marker is considered part of your clinical care and a separate consent will be required prior to this procedure. You may choose not to undergo this procedure but still participate in this study. In some cases, your respirologist may have already inserted a fiducial marker at the time of diagnostic bronchoscopy after discussions with yourself and your radiation oncologist. The "fiducial" marker would be used to guide your radiation treatments during your normal breathing cycle.
You will be assigned into one of the two study groups described below depending on the location of your tumour:
Schedule I (10 fractions): You will receive a total of 10 stereotactic radiation treatments, given over 3 weeks.
Schedule II (4 fractions): You will receive a total of 4 stereotactic radiation treatments, given over 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schedule I (10 fractions) | Experimental | Procedure: Fractionated Stereotactic RadiotherapySubjects will receive a total of 10 stereotactic radiation treatments, given over 3 weeks. |
| Schedule II (4 fractions) | Experimental | Procedure: Fractionated Stereotactic RadiotherapySubjects will receive a total of 4 stereotactic radiation treatments, given over 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- non-small cell lung cancer less than 6cm; no mediastinal or distant metastases
- Open to Alberta,Canada Residents
Key exclusion criteria (1 listed)
- tumour size greater than 6cm; inadequate pulmonary function(ie. FEV1 less than 0.8 L), Karnofsky performance status less than 70, multiple co-morbid conditions
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 |
|---|---|---|
| Fractionated Stereotactic Radiotherapy | Procedure or surgery | Schedule I (10 fractions), Schedule II (4 fractions) |
Primary outcome
Dose-limiting toxicity as defined by CTCAE V3 grade 4 or 5.
Time frame: At the completion of accrual, an analysis with respect to acute toxicity will be performed after all patients have been followed a minimum of 90 days from the start of RT.
Each schedule will be evaluated according to the occurrence of DLTs observed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
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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.
Harold P Lau, MD principal investigator
Tom Baker Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractionated Stereotactic Radiotherapy in people with Lung Neoplasms and Lung Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
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 2 inclusion and 1 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 21 Sep 2017. 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 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.
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?
Dose-limiting toxicity as defined by CTCAE V3 grade 4 or 5. (time frame: At the completion of accrual, an analysis with respect to acute toxicity will be performed after all patients have been followed a minimum of 90 days from the start of RT.). 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 21 Sep 2017.