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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Ontario Clinical Oncology Group (OCOG)
Sponsor:
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT01351116
First received: May 2, 2011
Last updated: August 25, 2014
Last verified: August 2014
  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 2014
Estimated Primary Completion Date: November 2014 (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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, British Columbia
Abbotsford Centre - BC Cancer Agency Recruiting
Abbotsford, British Columbia, Canada
Contact: Cathy Jackson       cjackson@bccancer.bc.ca   
Principal Investigator: Maha Almahmudi         
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         
Grand River Regional Cancer Centre Recruiting
Kitchener, Ontario, Canada, N2K 2R2
Contact: Carla Girolametto       carla.girolametto@grhosp.on.ca   
Principal Investigator: Ramana Rachankonda         
London Regional Cancer Centre Recruiting
London, Ontario, Canada
Contact: Deb Lewis       Deb.Lewis@lhsc.on.ca   
Principal Investigator: Edward Yu         
Sub-Investigator: Richard Malthaner         
UHN-Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada
Contact: Monique Cardoza       Monique.Cardoza@uhn.ca   
Principal Investigator: Saibish Elantholiparameswaran         
Windsor Regional Hospital Cancer Centre Recruiting
Windsor, Ontario, Canada, N8W 2X3
Contact: Patricia Dupuis       Patricia.Dupuis@wrh.on.ca   
Principal Investigator: Ming Pan         
Canada, Quebec
CHUQ - L'Hôtel-Dieu de Québec Recruiting
Québec City, Quebec, Canada, G1R 2J6
Contact: Josee Allard       Josee.Allard@chuq.qc.ca   
Principal Investigator: Anne Dagnault         
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Canadian Cancer Society Research Institute (CCSRI)
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: August 25, 2014
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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014