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

Phase 3

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Radiation: EBR plus HDRIB; Radiation: EBR

• Registration Number: NCT01351116
• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)

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.

Study Timeline

• Study First Submitted: 2011-05-02
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-10
• Study Start: 2011-10
• Primary Completion: 2016-06
• Status Verified: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EBR plus HDRIB	EBR plus HDRIB	External Beam Radiation (EBR) plus High Dose Rate Intraluminal Brachytherapy (HDRIB)
EBR	EBR	External Beam Radiation (EBR)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (8)

Cancer Centre of Southeastern Ontario at Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

London Regional Cancer Centre; 🇨🇦 London, Ontario, Canada

Grand River Regional Cancer Centre; 🇨🇦 Kitchener, Ontario, Canada

UHN-Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

Windsor Regional Hospital Cancer Centre; 🇨🇦 Windsor, Ontario, Canada

Abbotsford Centre - BC Cancer Agency; 🇨🇦 Abbotsford, British Columbia, Canada

CHUQ - L'Hôtel-Dieu de Québec; 🇨🇦 Québec City, Quebec, Canada