Extensive Stage Small Cel Lung CancerPhase 2NCT00643396
Phase II Trial of Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer
A Phase 2 study testing thoracic radiotherapy in people with Extensive Stage Small Cel Lung Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
The majority of patients with small cell lung cancer have incurable extensive stage disease. The usual initial treatment for this condition is chemotherapy which produces responses in about 50-80% of patients. Despite this, the cancer usually returns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive Stage Small Cel Lung Cancer
- What is being tested?
- thoracic radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2008to Jan 2012
- 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
- Histologic or cytologic confirmation of small cell lung cancer
- extensive stage disease
- adequate pulmonary function tests (FEV-1>1.0, DLCO>50%)
- patients of childbearing potential must practice adequate contraception
- age ≧ 18 years
- Karnofsky performance status ≧ 70
- documented objective response to initial chemotherapy
- signed study-specific informed consent form
Who cannot join
- complete or subtotal tumor resection
- non-small cell histology
- prior or concurrent malignancy except non-melanoma skin cancer unless disease-free for at least 5 years
- prior chest or neck RT
- inadequate pulmonary function tests (FEV-1<1.0 OR DLCO<50%)
- pregnant
Trial locations and contacts
1 site in 1 country.
About this study
The majority of patients with small cell lung cancer have incurable extensive stage disease. The usual initial treatment for this condition is chemotherapy which produces responses in about 50-80% of patients. Despite this, the cancer usually returns. Once common body region where it re-grows is in the chest, which can cause symptoms such as shortness of breath, cough, difficulty swallowing, pain and bleeding. These symptoms can worsen a patient's quality of life and in some situation be life-threatening. In this study , we propose to give patients who have extensive stage small cell lung cancer which responds to chemotherapy radiotherapy treatments to the chest. By giving this type of radiation before the cancer has a chance to re-grow, we hope to control the disease within the chest and prevent future symptoms that it may cause if the cancer were to re-grow in the chest. Patients treated on the protocol will be checked regularly for disease control, quality of life and radiation side effects, if any.
- Conditions
- Extensive Stage Small Cel Lung Cancer
- Being tested
- thoracic radiotherapy
- Keywords
- small cell lung cancer, radiotherapy
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic radiotherapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
local control
Measured: we anticipate completing accrual to the study in 12 months with most local failure events occuring within 2 years of treatment
Secondary outcomes (3)
radiotherapy toxicities
Measured: 1-2 years after study treatment
patient quality of life
Measured: 1-2 years after study treatment
overall survival
Measured: 1-2 years after study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Small Cel 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Cross Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Don Yee, MD, FRCPC, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643396
- Sponsor's protocol ID
- LU-23929/23929
- Status last verified
- Apr 2012
- First submitted
- 24 Mar 2008
- Last updated
- 26 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00643396
- Acronym / sponsor ID
- LU-23929/23929
- Conditions
- Extensive Stage Small Cel Lung Cancer
- Keywords
- small cell lung cancer, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Study start
- Feb 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Mar 2008 (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.
The majority of patients with small cell lung cancer have incurable extensive stage disease. The usual initial treatment for this condition is chemotherapy which produces responses in about 50-80% of patients. Despite this, the cancer usually returns. Once common body region where it re-grows is in the chest, which can cause symptoms such as shortness of breath, cough, difficulty swallowing, pain and bleeding. These symptoms can worsen a patient's quality of life and in some situation be life-threatening. In this study , we propose to give patients who have extensive stage small cell lung cancer which responds to chemotherapy radiotherapy treatments to the chest. By giving this type of radiation before the cancer has a chance to re-grow, we hope to control the disease within the chest and prevent future symptoms that it may cause if the cancer were to re-grow in the chest. Patients treated on the protocol will be checked regularly for disease control, quality of life and radiation side effects, if any.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologic or cytologic confirmation of small cell lung cancer
- extensive stage disease
- adequate pulmonary function tests (FEV-1>1.0, DLCO>50%)
- patients of childbearing potential must practice adequate contraception
- age ≧ 18 years
Key exclusion criteria (6 listed)
- complete or subtotal tumor resection
- non-small cell histology
- prior or concurrent malignancy except non-melanoma skin cancer unless disease-free for at least 5 years
- prior chest or neck RT
- inadequate pulmonary function tests (FEV-1<1.0 OR DLCO<50%)
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 |
|---|---|---|
| thoracic radiotherapy | Radiation | – |
Primary outcome
local control
Time frame: we anticipate completing accrual to the study in 12 months with most local failure events occuring within 2 years of treatment
3 secondary outcomes
radiotherapy toxicities
Time frame: 1-2 years after study treatment
patient quality of life
Time frame: 1-2 years after study treatment
overall survival
Time frame: 1-2 years after study treatment
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 26 Feb 2016.
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.
Don Yee, 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?
A Phase 2 study testing thoracic radiotherapy in people with Extensive Stage Small Cel 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 8 inclusion and 6 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 26 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?
local control (time frame: we anticipate completing accrual to the study in 12 months with most local failure events occuring within 2 years 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 26 Feb 2016.