Non-small Cell Lung CancerNCT00862030
CT-Based Versus Conventional Simulation for Palliative Radiotherapy of Non-Small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer, run by Alberta Health services at 1 site in Canada.
Trial summary
Radiotherapy (RT) treatment to the chest is a standard way of trying to decrease symptoms like cough or shortness of breath. Before any RT can be delivered, it must be planned, either using conventional x-rays ("fluoroscopy") or using computer tomography ("CT") scanning. 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?
- CT- simulation scan
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2009to Jan 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20
Who may be able to join
- Patients with local symptoms secondary to histologically-confirmed non-small cell lung cancer
- Patients who will be receiving palliative-intent external beam radiotherapy
- Patients who are clinically appropriate for conventional radiotherapy planning
- Patients who can provide written informed consent
Who cannot join
- Patients who cannot provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two-versus Three-Dimensional Treatment Planning for Patients Receiving Chest Radiotherapy for Symptom Control
Radiotherapy (RT) treatment to the chest is a standard way of trying to decrease symptoms like cough or shortness of breath. Before any RT can be delivered, it must be planned, either using conventional x-rays ("fluoroscopy") or using computer tomography ("CT") scanning. This study is being done because the investigators do not know which of these two common ways of RT planning is better for balancing both treating the cancer and decreasing side effects.
Read the detailed description
Standard RT planning will be performed under conventional simulation, followed by CT-simulation (for study purposes only). Retrospectively, 3D treatment fields will be designed using the CT-simulation data, and compared to the actual treatment fields planned using x-rays. Coverage of the tumour volume will be assessed, together with doses, field sizes and beam positions, to determine relative undercoverage of tumour and overcoverage of normal tissue between the two planning methods, if any.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- CT- simulation scan
- Keywords
- Palliative radiotherapy, Treatment planning, Non-small cell lung cancer
- 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.
CT- simulation scanProcedure or surgery
Patients who are receiving standard palliative radiotherapy planned under x-rays will also undergo 1 CT-simulation scan which they would otherwise not require. The planning x-rays and CT scan will then be compared dosimetrically
| Study group | Role | What they receive |
|---|---|---|
| 1 | Study Cohort Receives: Procedure: CT- simulation scan |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2011
- Study completionJan 2011
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.
- 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
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
- Investigators
- Dr. Alysa Fairchild, MD FRCPC, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862030
- Sponsor's protocol ID
- 24639
- Status last verified
- Aug 2011
- First submitted
- 13 Mar 2009
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two-versus Three-Dimensional Treatment Planning for Patients Receiving Chest Radiotherapy for Symptom Control
- ClinicalTrials.gov ID
- NCT00862030
- Acronym / sponsor ID
- 24639
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Palliative radiotherapy, Treatment planning, Non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 Mar 2009 (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.
Radiotherapy (RT) treatment to the chest is a standard way of trying to decrease symptoms like cough or shortness of breath. Before any RT can be delivered, it must be planned, either using conventional x-rays ("fluoroscopy") or using computer tomography ("CT") scanning. This study is being done because the investigators do not know which of these two common ways of RT planning is better for balancing both treating the cancer and decreasing side effects.
Detailed description
Standard RT planning will be performed under conventional simulation, followed by CT-simulation (for study purposes only). Retrospectively, 3D treatment fields will be designed using the CT-simulation data, and compared to the actual treatment fields planned using x-rays. Coverage of the tumour volume will be assessed, together with doses, field sizes and beam positions, to determine relative undercoverage of tumour and overcoverage of normal tissue between the two planning methods, if any.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: CT- simulation scanStudy Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20
Key inclusion criteria (4 listed)
- Patients with local symptoms secondary to histologically-confirmed non-small cell lung cancer
- Patients who will be receiving palliative-intent external beam radiotherapy
- Patients who are clinically appropriate for conventional radiotherapy planning
- Patients who can provide written informed consent
Key exclusion criteria (1 listed)
- Patients who cannot provide written informed consent
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 |
|---|---|---|
| CT- simulation scanPatients who are receiving standard palliative radiotherapy planned under x-rays will also undergo 1 CT-simulation scan which they would otherwise not require. The planning x-rays and CT scan will then be compared dosimetrically | Procedure or surgery | 1 |
Primary outcome
Not reported in the source record.
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 8 Aug 2011.
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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.
Dr. Alysa Fairchild, MD FRCPC principal investigator
AHS Cancer Control Alberta
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 Non-small Cell Lung Cancer, run by Alberta Health services 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 4 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 8 Aug 2011. 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.
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 8 Aug 2011.