RadImmune Studie
multizentrisch
Präoperative Immunmodulation durch lokale Strahlentherapie vor geplanter Operation im Frühstadium des Bronchialkarzinoms
Zusammenfassung
Insufficient migration and activation of tumour specific effector T cells seems to be the one important reason for inadequate host anti-tumour immune response. Ionizing radiation can induce a variety of immune responses. The goal of this randomized trial is to assess if a preoperative single fraction low dose radiation is able to improve anti-tumour immune response in operable early stage lung cancer.
Einschlusskriterien
- Histologically proven clinical stage I to IIA pulmonary adenocarcinoma
- Lung tumor is felt to be curatively resectable by the treating physicians
- Sufficient pulmonary function for lobectomy according to current guidelines
- The patient is free of distant metastases as confirmed by contrast-enhanced chest and upper abdomen CT-scan and by contrast-enhanced CT or MRI of the brain
- Age over 50years at the time of consent due to federal radiation protection law
- In female patients of childbearing potential there must be a negative pregnancy test
- Eastern Cooperative Oncology Group performance status of 0,1, 2 or 3 at the time of randomization
- Patients who the investigator believes can and will comply with the requirements of this protocol
- Written informed consent according to good clinical practise and national/regional regulations
Ausschlusskriterien
- The patient shows clinical signs of pneumonia
- The patient receives immunosuppressive drugs (alkylating agents, antimetabolites, methotrexate, azathioprine, mercaptopurine, cytotoxic antibodies, ciclosporin, tacrolimus, sirolimus, interferon, mycophenolate, small biological agents)
- The patient has been diagnosed with a potential immune mediated disease
- Elevated blood leukocyte count or erythrocyte sedimentation rate
- Pregnancy
- The patient has received any cancer specific treatment, including radiotherapy, immunotherapy, hormonal therapy or chemotherapy
- The patient is diagnosed with a concomitant malignancy and/or has a history of malignancy within the past five years or has had a malignancy that has been in complete remission for less than 5 years
- The patient needs chronic long term oxygen therapy
- The patient has undergone splenectomy
- The patient is known to be HIV positive
- The patient has an uncontrolled bleeding disorder