Immune Boost In Non-Small Cell Lung Cancer (RadImmune)

University Hospital Heidelberg

Status

Completed

Conditions

Non-small Cell Lung Cancer

Treatments

Radiation: Preoperative radiation

Study type

Interventional

Funder types

Other

Identifiers

NCT02319408

S-576/ 2013

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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