For patients with stage III non-small cell lung cancer, which is radically treated, we will investigate whether prophylactic cranial irradiation (PCI) should become standard of care to prevent brain metastases.
For this group of patients, brain metastases are one of the major sites of tumor failure. Radical therapy of symptomatic brain metastases is seldom possible and only very rarely, long term survival can be achieved. PCI has shown to reduce the incidence of brain metastases in patients with non-small cell lung cancer to the same extent as in limited disease small-cell lung cancer. However, the exact value of PCI in stage III NSCLC patient, treated with contemporary chemo-radiation schedule with or without surgery, remains unsettled. Therefore this study is launched, in order to investigate whether PCI should become the standard of care in patients with stage III NSCLC who are treated with curative intention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
315
* 18 fractions of 2Gy * 12 fractions of 2.5Gy * 10 fractions of 3 Gy
VU Medical Center
Amsterdam, Amsterdam, Netherlands
Maastro Clinic
Maastricht, Limburg, Netherlands
UMCG Groningen
Groningen, Provincie Groningen, Netherlands
UMC Utrecht
Utrecht, Utrecht, Netherlands
Proportion of patients developing symptomatic brain metastasis
Time frame: 24 months after randomisation
Time to develop neurological symptoms (confirmed or unconfirmed by imaging)
Time frame: 24 months after randomisation
Measurement of side effects (CTCAE3.0)
Time frame: 24 months after randomisation
Quality of Life
Measured by QLQ-C30 and EuroQol 5D
Time frame: 24 months after randomisation
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The Netherlands Cancer Institute
Amsterdam, Netherlands
RT Insitute Stedendriehoek
Deventer, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Dr. Bernard Verbeeten Institute
Tilburg, Netherlands
Isala Klinieken
Zwolle, Netherlands