Lung NeoplasmPhase 1NCT00469222
Hypofractionated Radiotherapy for Small Cell Lung Cancer
A Phase 1 study testing hypofractionated external beam in people with Lung Neoplasm and Small Cell Carcinoma, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
Current treatments for limited stage small cell lung cancer have poor cure rates. The addition of chest radiation to chemotherapy improves cure rates, but these cancers still come back in the chest 30-50% of the time. 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 external beam
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2007to Apr 2011
- Phase
- Phase 1
- 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
- patients with histologically or cytologically proven newly diagnosed small cell lung cancer
- confirmation from the treating radiation oncologist that the patient has limited stage disease (i.e. disease that can be encompassed by radiotherapy portals without exposing patient to excessive risk of radiation lung injury)
- adequate pulmonary function tests (FEV-1 >1.0, DLCO >50%)
- patients of childbearing potential must practice adequate contraception
- age greater than 18 years
- Karnofsky performance status greater than 70
- adequate hematologic, hepatic and renal function: Hb>100g/L, WBC > 4.0x109/L, neutrophils > 1.0x109/L, platelets > 100,000x109/L, calculated GFR based on Cockcroft-Gault formula of >60mL/min (NOTE: for cisplatin, GFR must be above 60ml/min; if less than 60ml/min the patient can not receive cisplatin but could be considered for carboplatin)
- patients must sign a study specific informed consent form
Who cannot join
- patient who have undergone complete or subtotal tumour resection
- evidence of non-small cell histology
- pericardial or pleural effusion on radiologic investigations regardless of cytology
- patients cannot be treated with 3DCRT with adherence to the dose volume constraints
- prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
- prior radiotherapy to the thorax or neck
Show all 11Show fewer
- prior chemotherapy
- patients with myocardial infarction within the preceding 6 months or symptomatic heart disease, including angina, congestive heart failure, uncontrolled arrhythmias
- compromised lung function with inadequate pulmonary function tests (FEV-1<1.0, DLCO <50%)
- pregnancy (patients with childbearing potential must practice appropriate contraception)
- patients who have not had the pre-treatment evaluations outlined in the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Dose Escalation Trial of Hypofractionated Limited-field External Beam Thoracic Radiotherapy for Limited Stage Small Cell Carcinoma of the Lung
Current treatments for limited stage small cell lung cancer have poor cure rates. The addition of chest radiation to chemotherapy improves cure rates, but these cancers still come back in the chest 30-50% of the time. Two factors which can improve control and cure rates for this cancer are increasing the chest radiation dose and minimizing the overall time it takes to complete radiation treatments. One method to achieve both of these goals is to give more radiation each day. This study is meant to study how tolerable and effective it would be to increase the intensity of chest radiation for small cell lung cancer patients by increasing the daily radiation dose. We aim to find the highest dose of chest radiotherapy that can be safely given with chemotherapy using this strategy. Patients in this trial will be monitored before, during and after their radiation and chemotherapy treatments for treatment side-effects, how effective treatments are at controlling their cancer and quality of life changes. Results from this trial will help to define more effective radiotherapy doses which are tolerable for this type of lung cancer and the quality of life changes patients experience when they undergo these treatments.
Read the detailed description
Local control and overall survival rates associated with the standard chemotherapy and radiotherapy given for limited stage small cell lung cancer are poor and emerging evidence from several studies suggests that intensifying the radiotherapy dose given may further improve patient outcomes, but at the cost of increased radiotherapy side effects. This proposal aims to study a novel method of intensifying chest radiotherapy dose via increasing the daily radiotherapy dose which is directed at regions of visible disease only. This strategy allows for delivery of increased radiation doses without prolonging overall treatment time and allowing potential regrowth of cancer cells. We aim to determine the maximum radiation dose which can be safely given with chemotherapy for limited stage small cell lung cancer and study the effects this type of radiation regimen with chemotherapy has on patient side effects and quality of life. Results from this trial will contribute to the development of the ideal radiotherapy regimen for limited stage small cell lung cancer. Our results will add to the literature studying the effects dose-intense radiation strategies for lung cancer have on patient quality of life.
- Conditions
- Lung Neoplasm, Small Cell Carcinoma
- Being tested
- hypofractionated external beam
- 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 external beamProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of acute grade 3 or higher radiotherapy toxicities
Secondary outcomes (1)
Overall survival and disease free survival, patient related quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startMar 2007
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469222
- Sponsor's protocol ID
- LU-11-0072 / 23117
- Status last verified
- Mar 2012
- First submitted
- 2 May 2007
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation Trial of Hypofractionated Limited-field External Beam Thoracic Radiotherapy for Limited Stage Small Cell Carcinoma of the Lung
- ClinicalTrials.gov ID
- NCT00469222
- Acronym / sponsor ID
- LU-11-0072 / 23117
- Conditions
- Lung Neoplasm, Small Cell Carcinoma
- Keywords
- small cell lung cancer, radiotherapy dose escalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Study start
- Mar 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 4 May 2007 (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.
Current treatments for limited stage small cell lung cancer have poor cure rates. The addition of chest radiation to chemotherapy improves cure rates, but these cancers still come back in the chest 30-50% of the time. Two factors which can improve control and cure rates for this cancer are increasing the chest radiation dose and minimizing the overall time it takes to complete radiation treatments. One method to achieve both of these goals is to give more radiation each day. This study is meant to study how tolerable and effective it would be to increase the intensity of chest radiation for small cell lung cancer patients by increasing the daily radiation dose. We aim to find the highest dose of chest radiotherapy that can be safely given with chemotherapy using this strategy. Patients in this trial will be monitored before, during and after their radiation and chemotherapy treatments for treatment side-effects, how effective treatments are at controlling their cancer and quality of life changes. Results from this trial will help to define more effective radiotherapy doses which are tolerable for this type of lung cancer and the quality of life changes patients experience when they undergo these treatments.
Detailed description
Local control and overall survival rates associated with the standard chemotherapy and radiotherapy given for limited stage small cell lung cancer are poor and emerging evidence from several studies suggests that intensifying the radiotherapy dose given may further improve patient outcomes, but at the cost of increased radiotherapy side effects. This proposal aims to study a novel method of intensifying chest radiotherapy dose via increasing the daily radiotherapy dose which is directed at regions of visible disease only. This strategy allows for delivery of increased radiation doses without prolonging overall treatment time and allowing potential regrowth of cancer cells. We aim to determine the maximum radiation dose which can be safely given with chemotherapy for limited stage small cell lung cancer and study the effects this type of radiation regimen with chemotherapy has on patient side effects and quality of life. Results from this trial will contribute to the development of the ideal radiotherapy regimen for limited stage small cell lung cancer. Our results will add to the literature studying the effects dose-intense radiation strategies for lung cancer have on patient quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 (8 listed)
- patients with histologically or cytologically proven newly diagnosed small cell lung cancer
- confirmation from the treating radiation oncologist that the patient has limited stage disease (i.e. disease that can be encompassed by radiotherapy portals without exposing patient to excessive risk of radiation lung injury)
- adequate pulmonary function tests (FEV-1 >1.0, DLCO >50%)
- patients of childbearing potential must practice adequate contraception
- age greater than 18 years
Key exclusion criteria (11 listed)
- patient who have undergone complete or subtotal tumour resection
- evidence of non-small cell histology
- pericardial or pleural effusion on radiologic investigations regardless of cytology
- patients cannot be treated with 3DCRT with adherence to the dose volume constraints
- prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
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 external beam | Procedure or surgery | – |
Primary outcome
Rates of acute grade 3 or higher radiotherapy toxicities
1 secondary outcome
Overall survival and disease free survival, patient related quality of life
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 25 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.
Don Yee, MD 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 1 study testing hypofractionated external beam 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 8 inclusion and 11 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 25 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Rates of acute grade 3 or higher radiotherapy toxicities. 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 25 Feb 2016.