Non-small Cell Lung CancerPhase 3BRACHYNCT01351116
A Trial to Evaluate the Improvement in Lung Cancer Patients Receiving Radiation With or Without Brachytherapy
A Phase 3 study testing EBR plus HDRIB and EBR in people with Non-small Cell Lung Cancer, run by Ontario Clinical Oncology Group (OCOG) at 8 sites in Canada.
Trial summary
A trial to improve the quality of life of patients with advanced non-small cell lung cancer (NSCLC) by evaluating the symptomatic improvements in lung cancer patients receiving external radiation with or without high dose internal radiation. 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?
- EBR plus HDRIB and EBR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 8 sitesCanada
- Study dates
- Oct 2011to Jan 2017
- Phase
- Phase 3
- 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
- Cytologic or histologic proof of non-small cell lung cancer (NSCLC)
- Stages III, IV or recurrent disease
- Documented endobronchial luminal disease by either endoscopy or CT-imaging
- Candidate for palliative thoracic radiation therapy because of cough, shortness of breath or hemoptysis
Who cannot join
- Age less than 18 years of age
- Uncontrolled or symptomatic brain metastases
- Anticipated survival of less than 3 months
- Systemic therapy planned to begin within 6 weeks following randomization
- Systemic therapy within 4 weeks of planned study randomization
- Any prior radiotherapy involving the lungs
Show all 12Show fewer
- Cardiac arrest or myocardial infarction within 6 months prior to study randomization
- Inability to receive sedation or undergo invasive procedures due to severe chronic obstructive pulmonary disease (COPD), bleeding disorders, or other medical conditions which will preclude the use of HDRIB
- Pregnancy, lactation, or failure to use dual-method contraception in pre-menopausal women
- Unwillingness or inability (e.g. incompetence, severe psychiatric disorders) to complete informed consent and the baseline QoL assessments required for the trial
- Having received an investigational agent within one month of study randomization
- Inability to attend regular follow-up evaluations due to psychiatric or addictive disorder or geographic inaccessibility
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Abbotsford Centre - BC Cancer Agency
Abbotsford British Columbia, British Columbia
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario
Grand River Regional Cancer Centre
Kitchener, Ontario, N2K 2R2
London Regional Cancer Centre
London, Ontario
CHUQ - L'Hôtel-Dieu de Québec
Québec, Quebec, G1R 2J6
UHN-Princess Margaret Cancer Centre
Toronto, Ontario
Windsor Regional Hospital Cancer Centre
Windsor, Ontario, N8W 2X3
About this study
Official title: A Phase III, Multi-centre, Randomized Trial to Evaluate the Symptomatic and Quality of Life Improvements in Lung Cancer Patients Receiving External Beam Radiation With or Without High Dose Rate Intraluminal Brachytherapy
A trial to improve the quality of life of patients with advanced non-small cell lung cancer (NSCLC) by evaluating the symptomatic improvements in lung cancer patients receiving external radiation with or without high dose internal radiation.
Read the detailed description
In patients with advanced NSCLC to compare the added benefit of High Dose Rate Intraluminal Brachytherapy (HDRIB) with External Beam Radiation (EBR). Benefit will be assessed by measuring the proportion of patients who achieve symptomatic improvement in lung cancer symptoms.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- EBR plus HDRIB, EBR
- Keywords
- brachytherapy, external beam radiation, high dose rate intraluminal brachytherapy, lung cancer, quality of life, radiation treatment, bronchus
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBR plus HDRIBRadiation
EBR of 20 Gy in 5 daily fractions over one week plus HDRIB of 14 Gy in 2 fractions over two weeks
EBRRadiation
EBR of 20 Gy in 5 daily fractions over one week
| Study group | Role | What they receive |
|---|---|---|
| EBR plus HDRIB | Experimental | External Beam Radiation (EBR) plus High Dose Rate Intraluminal Brachytherapy (HDRIB) Receives: Radiation: EBR plus HDRIB |
| EBR | Active comparator | External Beam Radiation (EBR) Receives: Radiation: EBR |
What is being measured
The primary outcome is the main question the study is designed to answer.
For each subject, a lung cancer-related symptomatic improvement at 6 weeks post randomization, defined as a 10-point improvement on a 100 point scale from the summary question of lung cancer symptoms
Measured: 6 weeks from randomization
Secondary outcomes (5)
Improvement in each lung cancer symptom as measured by the Lung Cancer Symptom Scale (LCSS) as defined by a 10-point improvement for cough, shortness of breath, hemoptysis and pain on the LCSS at 6 weeks post randomization
Measured: 6 weeks post randomization
Improvement in each lung cancer symptom and overall symptoms at any time after randomization
Measured: at 3, 6, 12, 18, 26, 34, 42 and 50 weeks post-randomization
A Quality of Life (QOL) improvement as measured be overall score of the LCSS, at each scheduled assessment point following randomization (Weeks 3, 6, 12, 26, 34, 42 and 50)
Measured: Weeks 3, 6, 12, 18, 26, 34, 42 and 50
Symptomatic progression-free survival (SPFS), defined as the time from randomization until death, use of chemotherapy, or the first post-randomization score on LCSS #7 which is 10 points or greater than the baseline score, or scored at 100.
Measured: From date of randomization until the date of first documented use of chemotherapy, or progression whichever came first, assessed up to 48 months
Overall survival, calculated from the date of randomization to the date of death
Measured: From date of randomization until the date of death from any cause assessed up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2016
- Study completionJan 2017
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Sponsor
- Investigators
- Ranjan Sur, Principal investigator, Juravinski Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351116
- Sponsor's protocol ID
- OCOG-2011-BRACHY
- Acronym
- BRACHY
- Status last verified
- Jan 2017
- First submitted
- 2 May 2011
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-centre, Randomized Trial to Evaluate the Symptomatic and Quality of Life Improvements in Lung Cancer Patients Receiving External Beam Radiation With or Without High Dose Rate Intraluminal Brachytherapy
- ClinicalTrials.gov ID
- NCT01351116
- Acronym / sponsor ID
- BRACHY / OCOG-2011-BRACHY
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- brachytherapy, external beam radiation, high dose rate intraluminal brachytherapy, lung cancer, quality of life, radiation treatment, bronchus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- Oct 2011
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 10 May 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.
A trial to improve the quality of life of patients with advanced non-small cell lung cancer (NSCLC) by evaluating the symptomatic improvements in lung cancer patients receiving external radiation with or without high dose internal radiation.
Detailed description
In patients with advanced NSCLC to compare the added benefit of High Dose Rate Intraluminal Brachytherapy (HDRIB) with External Beam Radiation (EBR). Benefit will be assessed by measuring the proportion of patients who achieve symptomatic improvement in lung cancer symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBR plus HDRIB | Experimental | Radiation: EBR plus HDRIBExternal Beam Radiation (EBR) plus High Dose Rate Intraluminal Brachytherapy (HDRIB) |
| EBR | Active comparator | Radiation: EBRExternal Beam Radiation (EBR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cytologic or histologic proof of non-small cell lung cancer (NSCLC)
- Stages III, IV or recurrent disease
- Documented endobronchial luminal disease by either endoscopy or CT-imaging
- Candidate for palliative thoracic radiation therapy because of cough, shortness of breath or hemoptysis
Key exclusion criteria (12 listed)
- Age less than 18 years of age
- Uncontrolled or symptomatic brain metastases
- Anticipated survival of less than 3 months
- Systemic therapy planned to begin within 6 weeks following randomization
- Systemic therapy within 4 weeks of planned study randomization
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 |
|---|---|---|
| EBR plus HDRIBEBR of 20 Gy in 5 daily fractions over one week plus HDRIB of 14 Gy in 2 fractions over two weeks | Radiation | EBR plus HDRIB |
| EBREBR of 20 Gy in 5 daily fractions over one week | Radiation | EBR |
Primary outcome
For each subject, a lung cancer-related symptomatic improvement at 6 weeks post randomization, defined as a 10-point improvement on a 100 point scale from the summary question of lung cancer symptoms
Time frame: 6 weeks from randomization
5 secondary outcomes
Improvement in each lung cancer symptom as measured by the Lung Cancer Symptom Scale (LCSS) as defined by a 10-point improvement for cough, shortness of breath, hemoptysis and pain on the LCSS at 6 weeks post randomization
Time frame: 6 weeks post randomization
Improvement in each lung cancer symptom and overall symptoms at any time after randomization
Time frame: at 3, 6, 12, 18, 26, 34, 42 and 50 weeks post-randomization
A Quality of Life (QOL) improvement as measured be overall score of the LCSS, at each scheduled assessment point following randomization (Weeks 3, 6, 12, 26, 34, 42 and 50)
Time frame: Weeks 3, 6, 12, 18, 26, 34, 42 and 50
Symptomatic progression-free survival (SPFS), defined as the time from randomization until death, use of chemotherapy, or the first post-randomization score on LCSS #7 which is 10 points or greater than the baseline score, or scored at 100.
Time frame: From date of randomization until the date of first documented use of chemotherapy, or progression whichever came first, assessed up to 48 months
Overall survival, calculated from the date of randomization to the date of death
Time frame: From date of randomization until the date of death from any cause assessed up to 48 months
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 24 Jan 2017.
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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.
Ranjan Sur principal investigator
Juravinski Cancer Centre
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EBR plus HDRIB and EBR in people with Non-small Cell Lung Cancer, run by Ontario Clinical Oncology Group (OCOG) at 8 sites 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 12 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 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
For each subject, a lung cancer-related symptomatic improvement at 6 weeks post randomization, defined as a 10-point improvement on a 100 point scale from the summary question of lung cancer symptoms (time frame: 6 weeks from randomization). 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 24 Jan 2017.