Small Cell Lung CancerPhase 1NCT01426841
Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer
A Phase 1 study testing Adaptive Radiation in people with Small Cell Lung Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
This study is intended to assess the feasibility of adjusting a radiation plan during its course to accommodate for a shrinking tumor target. The investigators hypothesize that an adaptive radiotherapy (RT) planning strategy for small cell lung cancer (SCLC) patients with chest-confined disease will allow for safe… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Adaptive Radiation
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2011to Apr 2015
- 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
- chest-confined disease (including bulky intrathoracic disease)
- adequate pulmonary function tests (FEV-1>1.0 L, DLCO>50%)
- patients of childbearing potential must practice adequate contraception
- Age > or = 18 years
- Karnofsky performance status > or = 70
- eligible for concurrent chemoradiotherapy
Who cannot join
- patients who have undergone complete or subtotal tumour resection
- evidence of non-small cell histology
- prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
- prior RT to the thorax or neck
- compromised lung function with inadequate pulmonary function tests (FEV-1<1.0,DLCO<50%)
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
This study is intended to assess the feasibility of adjusting a radiation plan during its course to accommodate for a shrinking tumor target. The investigators hypothesize that an adaptive radiotherapy (RT) planning strategy for small cell lung cancer (SCLC) patients with chest-confined disease will allow for safe delivery of higher doses of chest RT than a non-adaptive RT planning approach without subjecting normal critical structures to unacceptable doses of radiotherapy.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Adaptive Radiation
- Keywords
- Small cell lung cancer, Adaptive radiotherapy, Thoracic 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.
Adaptive RadiationRadiation
Thoracic Radiotherapy which is adapted or adjusted during its course to account for tumor volume shrinkage which occurs during treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach
Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach will be measured in centigray
Measured: 12-24 months
Secondary outcomes (2)
Local control and patterns of failure
Local control and patterns of failure
Measured: 12-24 months
Survival
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Don Yee, MD, FRCPC, Principal investigator, Cross Cancer Institute, Alberta Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426841
- Sponsor's protocol ID
- CCI Yee 25708
- Status last verified
- Oct 2014
- First submitted
- 15 Apr 2011
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01426841
- Acronym / sponsor ID
- CCI Yee 25708
- Conditions
- Small Cell Lung Cancer
- Keywords
- Small cell lung cancer, Adaptive radiotherapy, Thoracic radiotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 1 Sep 2011 (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 is intended to assess the feasibility of adjusting a radiation plan during its course to accommodate for a shrinking tumor target. The investigators hypothesize that an adaptive radiotherapy (RT) planning strategy for small cell lung cancer (SCLC) patients with chest-confined disease will allow for safe delivery of higher doses of chest RT than a non-adaptive RT planning approach without subjecting normal critical structures to unacceptable doses of radiotherapy.
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 (7 listed)
- patients with histologically or cytologically proven newly diagnosed small cell lung cancer
- chest-confined disease (including bulky intrathoracic disease)
- adequate pulmonary function tests (FEV-1>1.0 L, DLCO>50%)
- patients of childbearing potential must practice adequate contraception
- Age > or = 18 years
Key exclusion criteria (6 listed)
- patients who have undergone complete or subtotal tumour resection
- evidence of non-small cell histology
- prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
- prior RT to the thorax or neck
- compromised lung function with inadequate pulmonary function tests (FEV-1<1.0,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 |
|---|---|---|
| Adaptive RadiationThoracic Radiotherapy which is adapted or adjusted during its course to account for tumor volume shrinkage which occurs during treatment | Radiation | – |
Primary outcome
Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach
Time frame: 12-24 months
Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach will be measured in centigray
2 secondary outcomes
Local control and patterns of failure
Time frame: 12-24 months
Survival
Time frame: 12-24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
Related trials for Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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
Cross Cancer Institute, Alberta Health Services
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 Adaptive Radiation in people with Small Cell 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 7 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: status not confirmed, as of the sponsor's last update on 2 Oct 2014. 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?
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?
Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach (time frame: 12-24 months). 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 2 Oct 2014.