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Completed

NCT Number: NCT01351116

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Abbotsford Centre - BC Cancer Agency, Abbotsford British Columbia, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EBR plus HDRIB

Radiation

EBR of 20 Gy in 5 daily fractions over one week plus HDRIB of 14 Gy in 2 fractions over two weeks

EBR

Radiation

EBR of 20 Gy in 5 daily fractions over one week

Primary outcomes

  1. 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

    Time frame: 6 weeks from randomization

Secondary outcomes

  1. 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

    Time frame: 6 weeks post randomization

  2. Improvement in each lung cancer symptom and overall symptoms at any time after randomization

    Time frame: at 3, 6, 12, 18, 26, 34, 42 and 50 weeks post-randomization

  3. 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)

    Time frame: Weeks 3, 6, 12, 18, 26, 34, 42 and 50

  4. 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.

    Time frame: From date of randomization until the date of first documented use of chemotherapy, or progression whichever came first, assessed up to 48 months

  5. Overall survival, calculated from the date of randomization to the date of death

    Time frame: From date of randomization until the date of death from any cause assessed up to 48 months

Sponsors and collaborators

Lead sponsor

Ontario Clinical Oncology Group (OCOG)

Other

Collaborators

  • Canadian Cancer Society (CCS)

Registry information

Official study 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

Acronym: BRACHY

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
May 10, 2011
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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