A Trial to Evaluate the Improvement in Lung Cancer Patients Receiving Radiation With or Without Brachytherapy (BRACHY)
This study is currently recruiting participants.
Verified January 2013 by Ontario Clinical Oncology Group (OCOG)
Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborator:
Canadian Cancer Society
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT01351116
First received: May 2, 2011
Last updated: January 11, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Radiation: EBR plus HDRIB Radiation: EBR |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Ontario Clinical Oncology Group (OCOG):
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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: at time of death or earlier ] [ Designated as safety issue: No ]
- Overall survival, calculated from the date of randomization to the date of death [ Time Frame: date of death ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: EBR plus HDRIB
External Beam Radiation (EBR) plus High Dose Rate Intraluminal Brachytherapy (HDRIB)
|
Radiation: EBR plus HDRIB
EBR of 20 Gy in 5 daily fractions over one week plus HDRIB of 14 Gy in 2 fractions over two weeks
|
|
Active Comparator: EBR
External Beam Radiation (EBR)
|
Radiation: EBR
EBR of 20 Gy in 5 daily fractions over one week
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Cardiac arrest or myocardial infarction within 6 months prior to study randomization
- Inability to receive sedation or undergo invasive procedures due to severe COPD, bleeding disorders, or other medical conditions which will preclude the use of HDRIB
- Prior history of other cancers within the past 3 years, (excluding basal cell skin cancer and carcinoma in-situ of any site, such as cervix or breast).
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351116
Contacts
| Contact: Jim Wright | 905-387-9495 ext 64706 | jim.wright@jcc.hhsc.ca |
Locations
| Canada, Ontario | |
| Juravinski Cancer Centre | Recruiting |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Sub-Investigator: Ranjan Sur | |
| Principal Investigator: Jim Wright | |
| Sub-Investigator: Tim Whelan | |
| Sub-Investigator: Peter Ellis | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | Recruiting |
| Kingston, Ontario, Canada | |
| Contact: Tracie Hanna Hanna.Tracie@krcc.on.ca | |
| Principal Investigator: Conrad Falkson, MD | |
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Canadian Cancer Society
Investigators
| Principal Investigator: | Ranjan Sur | Juravinski Cancer Centre |
More Information
No publications provided
| Responsible Party: | Ontario Clinical Oncology Group (OCOG) |
| ClinicalTrials.gov Identifier: | NCT01351116 History of Changes |
| Other Study ID Numbers: | OCOG-2011-BRACHY |
| Study First Received: | May 2, 2011 |
| Last Updated: | January 11, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Ontario Clinical Oncology Group (OCOG):
|
brachytherapy external beam radiation high dose rate intraluminal brachytherapy lung cancer |
quality of life radiation treatment bronchus |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013