Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Image-Guided Functional Lung Avoidance Thoracic Radiotherapy for Lung Cancer: A Single-Blind Randomized Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03077854
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Thoracic radiotherapy (TRT) is a standard curative treatment for locally advanced, unresectable non-small cell lung cancer (NSCLC) and limited stage small cell lung cancer (SCLC). TRT has been recognized to cause moderate to severe lung injury in a substantial portion of patients. Conventional standard curative TRT planning techniques minimize the radiation dose to the anatomical lungs, without adaption of regional pulmonary function variations. The principal investigator hypothesized that preferential avoidance of functional lung during curative TRT may decrease the risk of pulmonary toxicity. Functional lung regions are identified using four- dimensional computed tomography for ventilation imaging. This randomized, single-blind trial will comprehensively assess the impact of functional lung avoidance on pulmonary toxicity, quality of life, and clinical outcome in patients receiving curative TRT for locally advanced NSCLC and SCLC.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer, Limited Stage Stage III Non-small Cell Lung Cancer Radiation: Functional Lung Avoidance Thoracic Radiotherapy Radiation: Standard Thoracic Radiotherapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Single-Blind Randomized Trial of Image-Guided Functional Lung Avoidance Thoracic Radiotherapy for Locally Advanced Non-Small Cell and Small Cell Lung Cancer
Study Start Date : June 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Functional Lung Avoidance-TRT

Functional Lung Avoidance Thoracic Radiotherapy

The avoidance thoracic radiotherapy treatment plan will be designed to optimize such that radiation dose to functional lung identified by four-dimensional (4D) CT ventilation imaging is as low as reasonably achievable

Radiation: Functional Lung Avoidance Thoracic Radiotherapy
  • Chemoradiation for non-small cell lung cancer: 60 Gy in 30 once-daily fractions (Dose reduction to 54 Gy in 30 once-daily fractions is allowed)
  • Radiation alone for non-small cell lung cancer: 60 Gy in 25 once-daily fractions (Dose reduction to 55 Gy in 25 once-daily fractions is allowed)
  • Chemoradiation for small-cell lung cancer: 45 Gy in 30 twice-daily fractions

Active Comparator: Standard-TRT

Standard Thoracic Radiotherapy

The standard thoracic radiotherapy treatment plan will be designed without reference to the functional lung 4D CT ventilation imaging

Radiation: Standard Thoracic Radiotherapy
  • Chemoradiation for non-small cell lung cancer: 60 Gy in 30 once-daily fractions (Dose reduction to 54 Gy in 30 once-daily fractions is allowed)
  • Radiation alone for non-small cell lung cancer: 60 Gy in 25 once-daily fractions (Dose reduction to 55 Gy in 25 once-daily fractions is allowed)
  • Chemoradiation for small-cell lung cancer: 45 Gy in 30 twice-daily fractions




Primary Outcome Measures :
  1. The pulmonary quality of life at 3 months post-radiotherapy [ Time Frame: Change from Baseline Functional Assessment of Cancer Therapy-Lung Cancer Subscale at 3 months ]
    Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS)


Secondary Outcome Measures :
  1. Changes of pulmonary function test post-radiotherapy [ Time Frame: At baseline, 3, 6, 12 months, and annually until year 5 post-radiotherapy ]
    Screening spirometry, diffusion capacity of lung for carbon monoxide

  2. Patient reported outcome (Quality of Life questionnaire by Functional Assessment of Cancer Therapy) [ Time Frame: At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy ]
    Functional Assessment of Cancer Therapy-Lung

  3. Patient reported outcome (Quality of Life questionnaire by EORTC Core) [ Time Frame: At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy ]
    EORTC Quality of Life-Core 30 questionnaire module

  4. Patient reported outcome (Quality of Life questionnaire by EORTC Lung cancer) [ Time Frame: At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy ]
    EORTC Quality of Life questionnaire -Lung cancer 13

  5. Acute toxicity [ Time Frame: From date of radiotherapy until 90 days after radiotherapy starts ]
    Common Toxicity Criteria for Adverse Events version 4

  6. Late toxicity [ Time Frame: 90 days after radiotherapy starts until the date of death from any cause, up to 60 months ]
    Common Toxicity Criteria for Adverse Events version 4

  7. Progression free survival [ Time Frame: From date of enrollment until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 60 months ]
    Number of participant without disease progression

  8. Overall survival [ Time Frame: From date of enrollment until the date of death from any cause, assessed up to 60 months ]
    Number of participant alive


Other Outcome Measures:
  1. Serum biomarkers in association with radiation pneumonitis [ Time Frame: At baseline, 1, 2, 3, 4, 6 months post-radiotherapy ]
    Tumor necrosis factor-alpha, Transforming growth factor-beta concentration measured by ELISA



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Patients with a histologic diagnosis of non-small cell carcinoma or small cell carcinoma of lung
  2. Locally advanced stage III A or III B lung carcinoma according to American Joint Committee on Cancer (AJCC) 7th edition or highly selected patients with oligo-metastatic disease amendable for thoracic radiotherapy with curative intent
  3. Not undergoing radical surgical resection
  4. Patients do not have prior radiotherapy to the thorax
  5. Age ≥ 20 years
  6. Karnofsky performance status (KPS) ≥ 60%.
  7. Women of childbearing potential and male participants must practice adequate contraception
  8. Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent

Exclusion criteria:

  1. Prior radiotherapy to thorax
  2. Unable to receive assigned radiation dose due to normal lung constraint
  3. Inability to attend full course of radiotherapy or follow-up visits
  4. Presence of metastatic disease. Patients who present with oligo-metastatic disease where all metastases have been ablated (with surgery or radiotherapy) or in complete remission after systemic therapy are candidates if they are receiving radiotherapy to the thoracic disease with curative intent
  5. Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:

    • Uncontrolled active infection requiring intravenous antibiotics at the time of registration
    • Transmural myocardial infarction ≤ 6 months prior to registration.
    • Unstable angina or congestive heart failure requiring hospitalization ≤ 6 months prior to registration.
    • Life-threatening uncontrolled clinically significant cardiac arrhythmias.
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
    • Uncontrolled psychiatric disorder.
  6. Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic.
  7. Pregnant or lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077854


Contacts
Layout table for location contacts
Contact: Feng-Ming Hsu, MD +886-2-23123456 ext 67061 hsufengming@ntuh.gov.tw

Locations
Layout table for location information
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Feng-Ming Hsu, MD    +886-2-23123456 ext 67061    hsufengming@ntuh.gov.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Feng-Ming Hsu, MD National Taiwan University Hospital

Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03077854     History of Changes
Other Study ID Numbers: 201604007RINA
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by National Taiwan University Hospital:
Lung Cancer
Radiotherapy
Biomarkers
Radiation Lung Injury
Quality of Life
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms