- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03077854
Image-Guided Functional Lung Avoidance Thoracic Radiotherapy for Lung Cancer: A Single-Blind Randomized Trial
A Single-Blind Randomized Trial of Image-Guided Functional Lung Avoidance Thoracic Radiotherapy for Locally Advanced Non-Small Cell and Small Cell Lung Cancer
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Feng-Ming Hsu, MD
- Numéro de téléphone: 67061 +886-2-23123456
- E-mail: hsufengming@ntuh.gov.tw
Lieux d'étude
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Taipei, Taïwan, 100
- Recrutement
- National Taiwan University Hospital
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Contact:
- Feng-Ming Hsu, MD
- Numéro de téléphone: 67061 +886-2-23123456
- E-mail: hsufengming@ntuh.gov.tw
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
The pulmonary quality of life at 3 months post-radiotherapy
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
La survie globale
Délai: De la date d'inscription jusqu'à la date du décès, quelle qu'en soit la cause, évalué jusqu'à 60 mois
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Nombre de participants vivants
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De la date d'inscription jusqu'à la date du décès, quelle qu'en soit la cause, évalué jusqu'à 60 mois
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Changes of pulmonary function test post-radiotherapy
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Serum biomarkers in association with radiation pneumonitis
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 201604007RINA
Plan pour les données individuelles des participants (IPD)
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