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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Radiation: EBR plus HDRIB
* Radiation: EBR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EBR plus HDRIB<br>External Beam Radiation (EBR) plus High Dose Rate Intraluminal Brachytherapy (HDRIB) | Radiation: EBR plus HDRIB<br>* EBR of 20 Gy in 5 daily fractions over one week plus HDRIB of 14 Gy in 2 fractions over two weeks<br>|
| Active Comparator: EBR<br>External Beam Radiation (EBR) | Radiation: EBR<br>* EBR of 20 Gy in 5 daily fractions over one week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 6 weeks from randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, quality of life, radiation treatment, bronchus, brachytherapy, external beam radiation, high dose rate intraluminal brachytherapy