Non Small Cell Lung CancerNCT01647334
Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer
A study testing Adaptive radiotherapy in people with Non Small Cell Lung Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This study aims to use a type of radiation (adaptive radiotherapy) to deliver curative-intent treatment to patients with non-small cell lung cancer, whose tumors would otherwise be too large for standard curative treatment. The study will use adaptive radiotherapy to achieve these goals. 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?
- Adaptive radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Dec 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
- Age 18 or older
- Willing to provide informed consent
- ECOG performance status 0-2
- Histologically confirmed non-small cell lung carcinoma
- Locally advanced stage IIIA or IIIB lung carcinoma according to AJCC 7th edition
- Expected lung V20 of 35-60%, as determined at the time of 4D-CT simulation
- Assessment by medical oncologist and radiation oncologist, with adequate hepatic and renal function for administration of cisplatin-based doublet chemotherapy, at the discretion of the medical oncologist
Who cannot join
- Serious medical comorbidities or other contraindications to radiotherapy or chemotherapy
- Prior history of lung cancer within 5 years
- Prior thoracic radiation at any time
- Metastatic disease
- in some select cases, patients with a solitary metastasis (i.e. brain metastasis) may receive radical chemoradiotherapy after resection/ablation of their metastatic lesion, as standard practice. In such cases, the patient may be enrolled onto this study at the discretion of the local principle investigator once the metastasis has been treated.
- inability to attend full course of radiotherapy of follow-up visits
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, N6A 4L6
About this study
This study aims to use a type of radiation (adaptive radiotherapy) to deliver curative-intent treatment to patients with non-small cell lung cancer, whose tumors would otherwise be too large for standard curative treatment. The study will use adaptive radiotherapy to achieve these goals. Adaptive radiotherapy is a process whereby treatment plans are modified during the course of treatment due to patient and tumor variations (ie. weight loss or tumor shrinkage). This may allow for dose escalation, while limiting the side effects.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Adaptive radiotherapy
- 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.
Adaptive radiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Shrinking Target Adaptive Radiotherapy | Experimental | Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer Receives: Radiation: Adaptive radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor reduction
Measured: 2.5 years (end of treatment)
Secondary outcomes (6)
Rate of tumor shrinkage
Measured: 2.5 years (end of treatment)
Change in lung dose
Measured: 2.5 years (end of treatment)
Delivered doses
Measured: 2.5 years (end of treatment)
Radiation pneumonitis rates
Measured: 6 months, 12 months, 18 months, 24 months, 30 months (semi-annually)
Local control
Measured: 2.5 years (end of treatment)
Overall survival
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- London Regional Cancer Program, Canada
- Responsible party
- Principal investigator, David Palma, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- David Palma, MD, PhD, Principal investigator, London Regional Cancer Program of the Lawson Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647334
- Sponsor's protocol ID
- Lung-START
- Status last verified
- Feb 2015
- First submitted
- 19 Jul 2012
- Last updated
- 19 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01647334
- Acronym / sponsor ID
- Lung-START
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- London Regional Cancer Program, Canada
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Jul 2012 (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.
This study aims to use a type of radiation (adaptive radiotherapy) to deliver curative-intent treatment to patients with non-small cell lung cancer, whose tumors would otherwise be too large for standard curative treatment. The study will use adaptive radiotherapy to achieve these goals. Adaptive radiotherapy is a process whereby treatment plans are modified during the course of treatment due to patient and tumor variations (ie. weight loss or tumor shrinkage). This may allow for dose escalation, while limiting the side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shrinking Target Adaptive Radiotherapy | Experimental | Radiation: Adaptive radiotherapyShrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 or older
- Willing to provide informed consent
- ECOG performance status 0-2
- Histologically confirmed non-small cell lung carcinoma
- Locally advanced stage IIIA or IIIB lung carcinoma according to AJCC 7th edition
Key exclusion criteria (7 listed)
- Serious medical comorbidities or other contraindications to radiotherapy or chemotherapy
- Prior history of lung cancer within 5 years
- Prior thoracic radiation at any time
- Metastatic disease
- in some select cases, patients with a solitary metastasis (i.e. brain metastasis) may receive radical chemoradiotherapy after resection/ablation of their metastatic lesion, as standard practice. In such cases, the patient may be enrolled onto this study at the discretion of the local principle investigator once the metastasis has been treated.
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 |
|---|---|---|
| Adaptive radiotherapy | Radiation | Shrinking Target Adaptive Radiotherapy |
Primary outcome
Tumor reduction
Time frame: 2.5 years (end of treatment)
6 secondary outcomes
Rate of tumor shrinkage
Time frame: 2.5 years (end of treatment)
Change in lung dose
Time frame: 2.5 years (end of treatment)
Delivered doses
Time frame: 2.5 years (end of treatment)
Radiation pneumonitis rates
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months (semi-annually)
Local control
Time frame: 2.5 years (end of treatment)
Overall survival
Time frame: 2.5 years
Results and safety
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
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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.
David Palma, MD, PhD principal investigator
London Regional Cancer Program of the Lawson Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive radiotherapy in people with Non Small Cell Lung Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 19 Feb 2015. 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 was stopped early (reason given: Poor accrual). Results are not available in the source record.
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?
Tumor reduction (time frame: 2.5 years (end of treatment)). 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 19 Feb 2015.