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

Ontario Clinical Oncology Group (OCOG)8 sites in 1 country134 target enrollmentOctober 2011

ConditionsNon-small Cell Lung Cancer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Non-small Cell Lung Cancer
Sponsor: Ontario Clinical Oncology Group (OCOG)
Enrollment: 134
Locations: 8
Primary Endpoint: 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
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

January 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ontario Clinical Oncology Group (OCOG)

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

Improvement in each lung cancer symptom and overall symptoms at any time after randomization(at 3, 6, 12, 18, 26, 34, 42 and 50 weeks post-randomization)
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.(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(From date of randomization until the date of death from any cause assessed up to 48 months)
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(6 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)(Weeks 3, 6, 12, 18, 26, 34, 42 and 50)