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

Ontario Clinical Oncology Group (OCOG)

Status and phase

Completed

Phase 3

Conditions

Non-small Cell Lung Cancer

Treatments

Radiation: EBR

Radiation: EBR plus HDRIB

Study type

Interventional

Funder types

Other

Identifiers

NCT01351116

OCOG-2011-BRACHY

Details and patient eligibility

About

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.

Full 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.

Enrollment

134 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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