Stan rekrutacji pochodzi z rejestrów badań i może się zmienić szybciej, niż zaktualizuje go sponsor. Nasz doradca sprawdzi aktualny stan w wybranym ośrodku. Nie publikujemy nazwisk lekarzy ani ich danych kontaktowych.
Cel badania
Opis z rejestru (w języku angielskim):
This is a randomized open-label multicentre Phase III superiority study of the effect of adding SBRT to the standard of care treatment on overall survival in patients with rare oligometastatic cancers.
Patients will be randomized in a 1:1 ratio between current standard of care treatment vs. standard of care treatment + SBRT to all sites of known metastatic disease.
The primary objective of this trial is to assess if the addition of stereotactic body radiotherapy (SBRT) to standard of care treatment improves overall survival (OS) as compared to standard of care treatment alone in patients with rare oligometastatic cancers.
Leczenie w badaniu
Lek / interwencja
Rola
Postać, podanie
Stereotactic body radiotherapy
Radioterapia
Palliative RT
Radioterapia
Kryteria udziału
Kryteria w języku angielskim, tak jak w rejestrze.
Kryteria włączenia kto może wziąć udział (10)
Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
Controlled primary tumour, defined as:
at least 3 months since original tumour treated definitively, with no progression at primary site
Total number of oligometastases of 1-5 including:
Brain metastases amenable to radiosurgery or fractionated stereotactic radiotherapy patient who had neurosurgical resection before trial inclusion are allowed and resected brain metastases count to the total number of oligometastases
All sites of disease can be safely treated based on the judgement of an experienced radiation oncologist
ECOG score 0-2
Life expectancy > 6 months
Age 18 or older
Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Kryteria wyłączenia kto nie może wziąć udziału (13)
Primary cancer of prostate, breast, lung or colorectal
Serious medical comorbidities precluding radiotherapy:
These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the GI tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma.
For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C)
Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated previously with radiation, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in the RTQA Guidelines. All such cases should be discussed with one of the study coordinators
Brain metastases only, without extra-cerebral metastases
Malignant pleural effusion, malignant ascites, meningeal carcinomatosis and peritoneal carcinomatosis
Maximum size of 6 cm for lesions outside the brain, except:
Bone metastases over 5 cm may be included, if in the opinion of the local radiation oncologist it can be treated safely (e.g. rib, scapula, pelvis)
Clinical or radiologic evidence of symptomatic spinal cord compression. Patients can be eligible if surgical resection has been performed, but the surgical site counts toward the total of up to 3 metastases.
Metastatic disease that invades any of the following: GI tract (including oesophagus, stomach, small or large bowel), mesenteric lymph nodes, or disseminated skin metastases and lymphangiosis
Pregnant or breast feeding women
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial
To główne kryteria z rejestru. Pełną listę i ostateczną decyzję o udziale ustala lekarz prowadzący badanie.
Zapytaj o udział w tym badaniu
Zadzwoń, a nasz doradca ds. badań sprawdzi z Tobą wstępnie kryteria i pomoże skontaktować się z ośrodkiem. Kwalifikację zawsze przeprowadza lekarz w ośrodku. Udział w badaniu jest bezpłatny i dobrowolny.
A phase 3, randomised, multi-center, open label trial to evaluate the safety and efficacy of intravesical nadofaragene firadenovec alone or in combination with chemotherapy…
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Subjects with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
Badane leki:FE-0999326+1
Miasta: Bydgoszcz, Poznań, WarszawaWiek: od 18 latSponsor: Ferring Pharmaceuticals A/S
Informacje pochodzą z publicznych rejestrów badań klinicznych (CTIS - Unia Europejska, ClinicalTrials.gov - USA) i są aktualizowane codziennie. Mogą różnić się od aktualnego stanu w ośrodku. Ostateczną kwalifikację do badania zawsze przeprowadza lekarz w ośrodku badawczym. Stan na 2 października 2026.
+8
+6
+1