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A Trial to Evaluate the Improvement in Lung Cancer Patients Receiving Radiation With or Without Brachytherapy (BRACHY)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01351116
First Posted: May 10, 2011
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
  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: None (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 ]

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 ]
  • 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 ]

Enrollment: 134
Study Start Date: October 2011
Study Completion Date: January 2017
Primary Completion Date: June 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351116


Locations
Canada, British Columbia
Abbotsford Centre - BC Cancer Agency
Abbotsford, British Columbia, Canada
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada, N2K 2R2
London Regional Cancer Centre
London, Ontario, Canada
UHN-Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Windsor Regional Hospital Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
CHUQ - L'Hôtel-Dieu de Québec
Québec City, Quebec, Canada, G1R 2J6
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Canadian Cancer Society Research Institute (CCSRI)
Investigators
Principal Investigator: Ranjan Sur Juravinski Cancer Centre
  More Information

Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT01351116     History of Changes
Other Study ID Numbers: OCOG-2011-BRACHY
First Submitted: May 2, 2011
First Posted: May 10, 2011
Last Update Posted: January 24, 2017
Last Verified: January 2017

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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms