Small Cell Lung Cancer, Limited StageNCT03077854
Image-Guided Functional Lung Avoidance Thoracic Radiotherapy for Lung Cancer: A Single-Blind Randomized Trial
A study testing Functional Lung Avoidance Thoracic Radiotherapy and Standard Thoracic Radiotherapy in people with Small Cell Lung Cancer, Limited Stage and Stage III Non-small Cell Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Small Cell Lung Cancer, Limited Stage, Stage III Non-small Cell Lung Cancer
- What is being tested?
- Functional Lung Avoidance Thoracic Radiotherapy and Standard Thoracic Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2016to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
- 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.
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Feng-Ming Hsu, MD, +886-2-23123456 ext. 67061, hsufengming@ntuh.gov.tw
About this study
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
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.
- Being tested
- Functional Lung Avoidance Thoracic Radiotherapy, Standard Thoracic Radiotherapy
- Keywords
- Lung Cancer, Radiotherapy, Biomarkers, Radiation Lung Injury, Quality of Life
- Medical subject headings
- Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Lung Avoidance Thoracic RadiotherapyRadiation
- 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 Thoracic RadiotherapyRadiation
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Radiation: Standard Thoracic Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pulmonary quality of life at 3 months post-radiotherapy
Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS)
Measured: Change from Baseline Functional Assessment of Cancer Therapy-Lung Cancer Subscale at 3 months
Secondary outcomes (8)
Changes of pulmonary function test post-radiotherapy
Screening spirometry, diffusion capacity of lung for carbon monoxide
Measured: 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)
Functional Assessment of Cancer Therapy-Lung
Measured: At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
Patient reported outcome (Quality of Life questionnaire by EORTC Core)
EORTC Quality of Life-Core 30 questionnaire module
Measured: At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
Patient reported outcome (Quality of Life questionnaire by EORTC Lung cancer)
EORTC Quality of Life questionnaire -Lung cancer 13
Measured: At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
Acute toxicity
Common Toxicity Criteria for Adverse Events version 4
Measured: From date of radiotherapy until 90 days after radiotherapy starts
Late toxicity
Common Toxicity Criteria for Adverse Events version 4
Measured: 90 days after radiotherapy starts until the date of death from any cause, up to 60 months
Progression free survival
Number of participant without disease progression
Measured: 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
Overall survival
Number of participant alive
Measured: From date of enrollment until the date of death from any cause, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study startJun 2016
- Primary completionMay 2021 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer, Limited StageStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng-Ming Hsu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077854
- Sponsor's protocol ID
- 201604007RINA
- Status last verified
- Mar 2019
- First submitted
- 27 Jun 2016
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03077854
- Acronym / sponsor ID
- 201604007RINA
- Keywords
- Lung Cancer, Radiotherapy, Biomarkers, Radiation Lung Injury, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 13 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Lung Avoidance-TRT | Experimental | Radiation: Functional Lung Avoidance Thoracic RadiotherapyFunctional 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 |
| Standard-TRT | Active comparator | Radiation: Standard Thoracic RadiotherapyStandard Thoracic Radiotherapy The standard thoracic radiotherapy treatment plan will be designed without reference to the functional lung 4D CT ventilation imaging |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Radiation | Functional Lung Avoidance-TRT |
| 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 | Radiation | Standard-TRT |
Primary outcome
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)
8 secondary outcomes
Changes of pulmonary function test post-radiotherapy
Time frame: 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)
Time frame: At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
Patient reported outcome (Quality of Life questionnaire by EORTC Core)
Time frame: At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
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
Acute toxicity
Time frame: From date of radiotherapy until 90 days after radiotherapy starts
Late toxicity
Time frame: 90 days after radiotherapy starts until the date of death from any cause, up to 60 months
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
Overall survival
Time frame: From date of enrollment until the date of death from any cause, assessed up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng-Ming Hsu, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Lung Avoidance Thoracic Radiotherapy and Standard Thoracic Radiotherapy in people with Small Cell Lung Cancer, Limited Stage and Stage III Non-small Cell Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng-Ming Hsu, MD (+886-2-23123456 ext. 67061, hsufengming@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.