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

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
EBR plus HDRIB
EBR
Sponsored by
Ontario Clinical Oncology Group (OCOG)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring brachytherapy, external beam radiation, high dose rate intraluminal brachytherapy, lung cancer, quality of life, radiation treatment, bronchus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abbotsford Centre - BC Cancer Agency
  • Juravinski Cancer Centre
  • Cancer Centre of Southeastern Ontario at Kingston General Hospital
  • Grand River Regional Cancer Centre
  • London Regional Cancer Centre
  • UHN-Princess Margaret Cancer Centre
  • Windsor Regional Hospital Cancer Centre
  • CHUQ - L'Hôtel-Dieu de Québec

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EBR plus HDRIB

EBR

Arm Description

External Beam Radiation (EBR) plus High Dose Rate Intraluminal Brachytherapy (HDRIB)

External Beam Radiation (EBR)

Outcomes

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

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
Improvement in each lung cancer symptom and overall symptoms at any time after 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)
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.
Overall survival, calculated from the date of randomization to the date of death

Full Information

First Posted
May 2, 2011
Last Updated
January 20, 2017
Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Canadian Cancer Society (CCS)
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1. Study Identification

Unique Protocol Identification Number
NCT01351116
Brief Title
A Trial to Evaluate the Improvement in Lung Cancer Patients Receiving Radiation With or Without Brachytherapy
Acronym
BRACHY
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Canadian Cancer Society (CCS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
brachytherapy, external beam radiation, high dose rate intraluminal brachytherapy, lung cancer, quality of life, radiation treatment, bronchus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EBR plus HDRIB
Arm Type
Experimental
Arm Description
External Beam Radiation (EBR) plus High Dose Rate Intraluminal Brachytherapy (HDRIB)
Arm Title
EBR
Arm Type
Active Comparator
Arm Description
External Beam Radiation (EBR)
Intervention Type
Radiation
Intervention Name(s)
EBR plus HDRIB
Intervention Description
EBR of 20 Gy in 5 daily fractions over one week plus HDRIB of 14 Gy in 2 fractions over two weeks
Intervention Type
Radiation
Intervention Name(s)
EBR
Intervention Description
EBR of 20 Gy in 5 daily fractions over one week
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ranjan Sur
Organizational Affiliation
Juravinski Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abbotsford Centre - BC Cancer Agency
City
Abbotsford
State/Province
British Columbia
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario at Kingston General Hospital
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
Grand River Regional Cancer Centre
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2K 2R2
Country
Canada
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
Country
Canada
Facility Name
UHN-Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Windsor Regional Hospital Cancer Centre
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 2X3
Country
Canada
Facility Name
CHUQ - L'Hôtel-Dieu de Québec
City
Québec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada

12. IPD Sharing Statement

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

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