Image-Guided Functional Lung Avoidance Thoracic Radiotherapy for Lung Cancer: A Single-Blind Randomized Trial
7. mars 2019 oppdatert av: National Taiwan University Hospital
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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
64
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Feng-Ming Hsu, MD
- Telefonnummer: 67061 +886-2-23123456
- E-post: hsufengming@ntuh.gov.tw
Studiesteder
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Taipei, Taiwan, 100
- Rekruttering
- National Taiwan University Hospital
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Ta kontakt med:
- Feng-Ming Hsu, MD
- Telefonnummer: 67061 +886-2-23123456
- E-post: hsufengming@ntuh.gov.tw
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion criteria:
- 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
Exclusion criteria:
- 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.
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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 |
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Aktiv komparator: Standard-TRT
Standard Thoracic Radiotherapy The standard thoracic radiotherapy treatment plan will be designed without reference to the functional lung 4D CT ventilation imaging |
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The pulmonary quality of life at 3 months post-radiotherapy
Tidsramme: Change from Baseline Functional Assessment of Cancer Therapy-Lung Cancer Subscale at 3 months
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Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS)
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Change from Baseline Functional Assessment of Cancer Therapy-Lung Cancer Subscale at 3 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Total overlevelse
Tidsramme: Fra innmeldingsdato til dødsdato uansett årsak, vurdert opp til 60 måneder
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Antall deltakere i live
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Fra innmeldingsdato til dødsdato uansett årsak, vurdert opp til 60 måneder
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Changes of pulmonary function test post-radiotherapy
Tidsramme: At baseline, 3, 6, 12 months, and annually until year 5 post-radiotherapy
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Screening spirometry, diffusion capacity of lung for carbon monoxide
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At baseline, 3, 6, 12 months, and annually until year 5 post-radiotherapy
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Patient reported outcome (Quality of Life questionnaire by Functional Assessment of Cancer Therapy)
Tidsramme: At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
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Functional Assessment of Cancer Therapy-Lung
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At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
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Patient reported outcome (Quality of Life questionnaire by EORTC Core)
Tidsramme: At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
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EORTC Quality of Life-Core 30 questionnaire module
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At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
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Patient reported outcome (Quality of Life questionnaire by EORTC Lung cancer)
Tidsramme: At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
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EORTC Quality of Life questionnaire -Lung cancer 13
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At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
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Acute toxicity
Tidsramme: From date of radiotherapy until 90 days after radiotherapy starts
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Common Toxicity Criteria for Adverse Events version 4
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From date of radiotherapy until 90 days after radiotherapy starts
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Late toxicity
Tidsramme: 90 days after radiotherapy starts until the date of death from any cause, up to 60 months
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Common Toxicity Criteria for Adverse Events version 4
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90 days after radiotherapy starts until the date of death from any cause, up to 60 months
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Progression free survival
Tidsramme: 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
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Number of participant without disease progression
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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
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Serum biomarkers in association with radiation pneumonitis
Tidsramme: At baseline, 1, 2, 3, 4, 6 months post-radiotherapy
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Tumor necrosis factor-alpha, Transforming growth factor-beta concentration measured by ELISA
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At baseline, 1, 2, 3, 4, 6 months post-radiotherapy
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
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Studer hoveddatoer
Studiestart
1. juni 2016
Primær fullføring (Forventet)
1. mai 2021
Studiet fullført (Forventet)
1. mai 2023
Datoer for studieregistrering
Først innsendt
27. juni 2016
Først innsendt som oppfylte QC-kriteriene
7. mars 2017
Først lagt ut (Faktiske)
13. mars 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. mars 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. mars 2019
Sist bekreftet
1. mars 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 201604007RINA
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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