This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments ebr plus hdrib, ebr
Phase phase 3
Sponsor Ontario Clinical Oncology Group (OCOG)
Collaborator Canadian Cancer Society Research Institute (CCSRI)
Start date October 2011
End date June 2016
Trial size 134 participants
Trial identifier NCT01351116, OCOG-2011-BRACHY


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
External Beam Radiation (EBR) plus High Dose Rate Intraluminal Brachytherapy (HDRIB)
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)
External Beam Radiation (EBR)
EBR of 20 Gy in 5 daily fractions over one week

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 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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Ranjan Sur
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Ontario Clinical Oncology Group (OCOG).