Clinical trial NCT01351116: A Trial to Evaluate the Improvement in Lung Cancer Patients Receiving Radiation With or Without Brachytherapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: brachytherapy
external beam radiation
high dose rate intraluminal brachytherapy
lung cancer
quality of life
radiation treatment
bronchus
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2011-05-10
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: 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
timeFrame: 6 weeks from randomization
Secondary outcomes:
measure: 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
timeFrame: 6 weeks post randomization
measure: Improvement in each lung cancer symptom and overall symptoms at any time after randomization
timeFrame: at 3, 6, 12, 18, 26, 34, 42 and 50 weeks post-randomization
measure: 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)
timeFrame: Weeks 3, 6, 12, 18, 26, 34, 42 and 50
measure: 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.
timeFrame: From date of randomization until the date of first documented use of chemotherapy, or progression whichever came first, assessed up to 48 months
measure: Overall survival, calculated from the date of randomization to the date of death
timeFrame: From date of randomization until the date of death from any cause assessed up to 48 months
Other outcomes:
Locations:
city: Abbotsford
country: Canada
facility: Abbotsford Centre - BC Cancer Agency
state: British Columbia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Regional Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: UHN-Princess Margaret Cancer Centre
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Hospital Cancer Centre
state: Ontario
city: Québec City
country: Canada
facility: CHUQ - L'Hôtel-Dieu de Québec
state: Quebec
Study officials:
affiliation: Juravinski Cancer Centre
name: Ranjan Sur
role: PRINCIPAL_INVESTIGATOR
References: