Phase I, Open-Label Study With Dendritic Cell therapy (MesoPher) In Combination With Extended- Pleurectomy/Decortication After Chemotherapy in Subjects With Resectable Mesothelioma.
Studiedetails
Type carcinoma: | Mesothelioom |
---|---|
Stadium: | I - IIIA |
Mutatie: | n/a |
Lijn: | 1ste |
Site: | Erasmus MC |
Contactgegevens: | long.oncologie@erasmusmc.nl |
Website: | https://-/ |
Inclusiecriteria
- Patients with a histologically confirmed diagnosis of epithelioid MPM who are eligible
for 2 to 4 cycles of platinum-based chemotherapy. Patients who progressed after chemotherapy
will not be discontinued from the trial if they are still eligible for eP/D and none
of the exclusion criteria is present (e.g. local progression with only focal chest invasion). - Resectable disease defined by stage cT1-3, N0-1, M0 (I to IIIA) according to UICC
TNM classification (8th edition). FDG-PET-CT scan with fusion images showing absence
of M1, N2 involvement is required. Focal chest wall lesions are acceptable. - Tumor tissue available after completing chemotherapy and before starting treatment
with DCT. Tumor tissue can be obtained by either a CT-guided needle biopsy or a
VATS surgical biopsy. - Fit to receive platinum-based chemotherapy (as per standard of care of the treating
physician/Institution) and undergo a P/D with optional removal of hemidiaphragm and
pericardium. The responsible surgeon and chest physician should judge the required
fitness prior to registration, taking into account the results of all the relevant (i.e. pulmonary,
cardiac) examinations.
Exclusiecriteria
Clinical or radiological invasion of mediastinal structures (heart, aorta, spine, esophagus,
etc.) and widespread chest wall invasion (stage T4). Involvement of N2 nodes.
Stage IV (metastatic disease).
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EVOKE
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CUP/EAP/DAP/DRUP
Lijst van verschillende programma's
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