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

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: No masking 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:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

U.S. FDA Resources

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


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

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

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
Study First Received:	May 2, 2011
Last Updated:	January 20, 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

ClinicalTrials.gov processed this record on July 07, 2017

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