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

NCT03077854 | Unknown DMC

• 1 other identifier: 201604007RINA
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• The pulmonary quality of life at 3 months post-radiotherapy

  Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS)

  Change from Baseline Functional Assessment of Cancer Therapy-Lung Cancer Subscale at 3 months

Secondary Outcomes (8)

• Changes of pulmonary function test post-radiotherapy

  At baseline, 3, 6, 12 months, and annually until year 5 post-radiotherapy

• Patient reported outcome (Quality of Life questionnaire by Functional Assessment of Cancer Therapy)

  At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy

• Patient reported outcome (Quality of Life questionnaire by EORTC Core)

  At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy

• Patient reported outcome (Quality of Life questionnaire by EORTC Lung cancer)

  At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy

• Acute toxicity

  From date of radiotherapy until 90 days after radiotherapy starts

Other Outcomes (1)

• Serum biomarkers in association with radiation pneumonitis

  At baseline, 1, 2, 3, 4, 6 months post-radiotherapy

Study Arms (2)

Functional Lung Avoidance-TRT

EXPERIMENTAL

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

Standard-TRT

ACTIVE COMPARATOR

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

Interventions

Functional Lung Avoidance Thoracic Radiotherapy RADIATION

* 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

Functional Lung Avoidance-TRT

Standard Thoracic Radiotherapy RADIATION

* 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

Standard-TRT

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a histologic diagnosis of non-small cell carcinoma or small cell carcinoma of lung
• 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
• Not undergoing radical surgical resection
• Patients do not have prior radiotherapy to the thorax
• Age ≥ 20 years
• Karnofsky performance status (KPS) ≥ 60%.
• Women of childbearing potential and male participants must practice adequate contraception
• Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent

You may not qualify if:

• Prior radiotherapy to thorax
• Unable to receive assigned radiation dose due to normal lung constraint
• Inability to attend full course of radiotherapy or follow-up visits
• 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
• 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.
• Pregnant or lactating women

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Feng-Ming Hsu, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng-Ming Hsu, MD

CONTACT

+886-2-23123456; hsufengming@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: March 13, 2017
• Study Start: June 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2023
• Last Updated: March 11, 2019

Record last verified: 2019-03

Locations

TW (1)