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

Non-small Cell Lung Cancer Clinical Trial

— BRACHY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351116
• Other study ID #: OCOG-2011-BRACHY
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2011
• Last updated: January 20, 2017
• Start date: October 2011
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: January 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Radiation:
• 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
• EBR
EBR of 20 Gy in 5 daily fractions over one week

Locations

Country	Name	City	State
Canada	Abbotsford Centre - BC Cancer Agency	Abbotsford	British Columbia
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Cancer Centre of Southeastern Ontario at Kingston General Hospital	Kingston	Ontario
Canada	Grand River Regional Cancer Centre	Kitchener	Ontario
Canada	London Regional Cancer Centre	London	Ontario
Canada	CHUQ - L'Hôtel-Dieu de Québec	Québec City	Quebec
Canada	UHN-Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Windsor Regional Hospital Cancer Centre	Windsor	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Canadian Cancer Society Research Institute (CCSRI)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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