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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

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


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.


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

- Prior history of other cancers within the past 3 years, (excluding basal cell skin
cancer and carcinoma in-situ of any site, such as cervix or breast).

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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

Outcome Time Frame:

6 weeks from randomization

Safety Issue:

No

Principal Investigator

Ranjan Sur

Investigator Role:

Principal Investigator

Investigator Affiliation:

Juravinski Cancer Centre

Authority:

Canada: Ethics Review Committee

Study ID:

OCOG-2011-BRACHY

NCT ID:

NCT01351116

Start Date:

October 2011

Completion Date:

December 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • brachytherapy
  • external beam radiation
  • high dose rate intraluminal brachytherapy
  • lung cancer
  • quality of life
  • radiation treatment
  • bronchus
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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