Clinical trial NCT03077854: Image-Guided Functional Lung Avoidance Thoracic Radiotherapy for Lung Cancer: A Single-Blind Randomized Trial
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Small Cell Lung Cancer, Limited Stage
Stage III Non-small Cell Lung Cancer
Keywords: Lung Cancer
Radiotherapy
Biomarkers
Radiation Lung Injury
Quality of Life
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The pulmonary quality of life at 3 months post-radiotherapy
timeFrame: Change from Baseline Functional Assessment of Cancer Therapy-Lung Cancer Subscale at 3 months
Secondary outcomes:
measure: Changes of pulmonary function test post-radiotherapy
timeFrame: At baseline, 3, 6, 12 months, and annually until year 5 post-radiotherapy
measure: Patient reported outcome (Quality of Life questionnaire by Functional Assessment of Cancer Therapy)
timeFrame: At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
measure: Patient reported outcome (Quality of Life questionnaire by EORTC Core)
timeFrame: At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
measure: Patient reported outcome (Quality of Life questionnaire by EORTC Lung cancer)
timeFrame: At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
measure: Acute toxicity
timeFrame: From date of radiotherapy until 90 days after radiotherapy starts
measure: Late toxicity
timeFrame: 90 days after radiotherapy starts until the date of death from any cause, up to 60 months
measure: Progression free survival
timeFrame: 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
measure: Overall survival
timeFrame: From date of enrollment until the date of death from any cause, assessed up to 60 months
Other outcomes:
measure: Serum biomarkers in association with radiation pneumonitis
timeFrame: At baseline, 1, 2, 3, 4, 6 months post-radiotherapy
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Feng-Ming Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References: