Lung NeoplasmPhase 2NCT00907569
Hypofractionated Radiotherapy for Limited Stage Small Cell Lung Cancer
A Phase 2 study testing Hypofractionated Chest Radiotherapy in people with Lung Neoplasm and Small Cell Carcinoma, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
It is accepted that giving higher doses of chest radiation in as short a time span as possible improves chances of cure. In this study, the investigators propose to give an increased dose of chest radiotherapy for limited stage small cell lung cancer patients using a strategy of giving a slightly higher daily dose of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasm, Small Cell Carcinoma
- What is being tested?
- Hypofractionated Chest Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2009to Apr 2011
- Phase
- Phase 2
- 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
- limited stage small cell lung cancer
- adequate pulmonary function test (FEV1 >1.0 L, DLCO >50%)
- signed study consent
- age at least 18 years
- Karnofsky performance status as least 70%
- eligible to receive standard concurrent small cell cancer chemotherapy
Who cannot join
- extensive stage disease
- mixed non small cell and small cell histology
- inadequate pulmonary function tests
- not eligible for concurrent chemotherapy
- subtotal or total tumor resection
- previous chest/neck radiotherapy
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- prior or concurrent malignancy except non-melanomatous skin unless disease free for last 5 years
- pregnant
- prior chemotherapy for another malignancy
- patients with myocardial infarction within the preceding 6 months of symptomatic heart disease, including, angina, congestive heart failure, uncontrolled arrhythmias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial of Increased Chest Radiotherapy Dose for Limited Stage Small Cell Lung Cancer
It is accepted that giving higher doses of chest radiation in as short a time span as possible improves chances of cure. In this study, the investigators propose to give an increased dose of chest radiotherapy for limited stage small cell lung cancer patients using a strategy of giving a slightly higher daily dose of radiotherapy than normal. The investigators hypothesize that our proposed chest radiotherapy dose will improve 2-year overall survival rates in patients with limited stage small cell lung cancer.
Read the detailed description
The ideal chest radiotherapy dose/fractionation scheme for limited stage small cell lung cancer is undefined. Strategies of radiotherapy dose intensification with minimization of overall treatment time are felt to improve cure rates for LS-SCLC. Hypofractionation (giving higher than standard daily doses) facilitates both of these goals. In this study, we propose to use a dose escalated hypofractionated regimen of chest radiotherapy for patients with LS-SCLC.
- Conditions
- Lung Neoplasm, Small Cell Carcinoma
- Being tested
- Hypofractionated Chest Radiotherapy
- Keywords
- Small cell lung cancer, radiotherapy dose escalation
- Medical subject headings
- Lung Neoplasms, Carcinoma, Small Cell, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Chest RadiotherapyRadiation
Hypofractionated chest radiotherapy regimen of 58 Gy delivered in 25 fractions in 5 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year overall survival
Measured: 2011
Secondary outcomes (2)
Quality of life
Measured: 2011
Patterns of Failure
Measured: 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Cross Cancer Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907569
- Sponsor's protocol ID
- 24762
- Status last verified
- Sep 2011
- First submitted
- 20 May 2009
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Increased Chest Radiotherapy Dose for Limited Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00907569
- Acronym / sponsor ID
- 24762
- Conditions
- Lung Neoplasm, Small Cell Carcinoma
- Keywords
- Small cell lung cancer, radiotherapy dose escalation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Study start
- Jun 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 22 May 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.
It is accepted that giving higher doses of chest radiation in as short a time span as possible improves chances of cure. In this study, the investigators propose to give an increased dose of chest radiotherapy for limited stage small cell lung cancer patients using a strategy of giving a slightly higher daily dose of radiotherapy than normal. The investigators hypothesize that our proposed chest radiotherapy dose will improve 2-year overall survival rates in patients with limited stage small cell lung cancer.
Detailed description
The ideal chest radiotherapy dose/fractionation scheme for limited stage small cell lung cancer is undefined. Strategies of radiotherapy dose intensification with minimization of overall treatment time are felt to improve cure rates for LS-SCLC. Hypofractionation (giving higher than standard daily doses) facilitates both of these goals. In this study, we propose to use a dose escalated hypofractionated regimen of chest radiotherapy for patients with LS-SCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- limited stage small cell lung cancer
- adequate pulmonary function test (FEV1 >1.0 L, DLCO >50%)
- signed study consent
- age at least 18 years
- Karnofsky performance status as least 70%
Key exclusion criteria (10 listed)
- extensive stage disease
- mixed non small cell and small cell histology
- inadequate pulmonary function tests
- not eligible for concurrent chemotherapy
- subtotal or total tumor resection
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 |
|---|---|---|
| Hypofractionated Chest RadiotherapyHypofractionated chest radiotherapy regimen of 58 Gy delivered in 25 fractions in 5 weeks. | Radiation | – |
Primary outcome
2-year overall survival
Time frame: 2011
2 secondary outcomes
Quality of life
Time frame: 2011
Patterns of Failure
Time frame: 2011
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 22 Feb 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypofractionated Chest Radiotherapy in people with Lung Neoplasm and Small Cell Carcinoma, 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 6 inclusion and 10 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 22 Feb 2016. 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.
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?
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?
2-year overall survival (time frame: 2011). 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 22 Feb 2016.