- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01290809
Prophylactic Cranial Irradiation (PCI) Cognitive Tests in Non-small Cell Lung Cancer (NSCLC) Patients
Cognitive Sequelae of Prophylactic Cranial Irradiation in Non-small Cell Lung Cancer Patients
Stage III non-small cell lung cancer (NSCLC) patients constitute a significant proportion of the lung cancer population. The prognosis of these patients has improved over the years due the introduction of combined modality treatment, including high-dose chemo-radiotherapy. The brain, however, remains one of the major sites of failure. Patients with brain metastasis suffer from a variety of neurological, cognitive and emotional difficulties that are known to adversely affect the health-related quality of life. Prophylactic Cranial Irradiation (PCI) can prevent or delay the development of brain metastasis, and as such can improve neurological disease-free survival and consequently health-related quality of life. But survival is short, and toxicities are real, as PCI in itself can also induce adverse effects. The cognitive adverse effects of PCI are not sufficiently illuminated and documented, due to the lack of formal and systematic evaluation in patient populations expected to have short survival. Also, recent attempts to reduce cognitive side effects of PCI by the application of hippocampal-avoidance PCI in order to prevent memory deficits have not been fully evaluated yet.
Before PCI can be offered routinely to stage III NSCLC patients in daily practice, the costs and benefits of this therapy should be investigated properly, to allow for well-informed treatment choices.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Amsterdam, Holland
- VU University Medical Center
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Amsterdam, Holland
- Academic Medical Center
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Amsterdam, Holland
- NKI
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Groningen, Holland
- University Medical Center Groningen
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- UICC stage III A or III B (without malignant pleural or pericardial effusion) non-small cell lung cancer
- Whole body PDG-PET scan before the start of therapy available: no distant metastasis.
- CT or preferably MRI of the brain before the start of radical therapy available; no brain metastasis.
- Platinum-based chemotherapy is mandatory.
- Radical local therapy: concurrent or sequential chemotherapy and radiotherapy with or without surgery.
- Radiotherapy dose without surgery to at least biological equivalent of 60 Gy.
- No prior cranial irradiation.sufficient proficiency in Dutch language
- sufficient proficiency in Dutch language
- MRI (and not CT scan) pre-PCI
Exclusion Criteria:
- none
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Crossover
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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Prophylactic Cranial Irradiation
NSCLC patients treated with whole brain PCI: cognitive functioning as assessed by neuropsychological tests?
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no Prophylactic Cranial Irradiation
NSCLC patients not treated with whole brain PCI: cognitive functioning as assessed by neuropsychological tests?
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
cognitive sequelae
Tidsramme: 36 months
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The proposed study will investigate the cognitive sequelae of PCI in NSCLC patients in the context of a phase III randomized trial (Nederlandse vereniging van artsen voor longziekten en tuberculose: NVALT-11) on the efficacy of PCI in decreasing the proportion of NSCLC patients developing brain metastasis, and the impact of PCI on neurological symptoms and health-related quality of life.
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36 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Dirk deruysscher, Maastro Clinic, The Netherlands
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 093074
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-
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Bio-Thera SolutionsAfsluttet
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Jiangsu Province Nanjing Brain HospitalRekruttering
-
TYK Medicines, IncRekruttering
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Radboud University Medical CenterPfizer; ImaginAb, Inc.; University Hospital TuebingenIkke rekrutterer endnuNSCLCTyskland, Holland
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Beta Pharma, Inc.Afsluttet