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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02319408
Recruitment Status : Completed
First Posted : December 18, 2014
Last Update Posted : May 23, 2022
Sponsor:
Collaborators:
German Cancer Research Center
Heidelberg University
Information provided by (Responsible Party):
Dr. med. Seyer Safi, University Hospital Heidelberg

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Radiation: Preoperative radiation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized Phase II Study of Radiation Induced Immune Boost in Operable Non-small Cell Lung Cancer
Study Start Date : April 2016
Actual Primary Completion Date : February 2020
Actual Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
No Intervention: No radiation
Lobectomy for lung cancer without preoperative radiation
Experimental: Preoperative radiation
Lobectomy for lung cancer with preoperative radiation
 Radiation: Preoperative radiation
Lobectomy for lung cancer following preoperative radiation


Outcome Measures
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Primary Outcome Measures :
  1. Cluster of differentiation (CD)8+ T cells in resected NSCLC [ Time Frame: 7 days ]
    Frequencies of CD8+ T cells in resected NSCLC tumors determined by immunohistochemistry


Secondary Outcome Measures :
  1. T cell subtypes in resected NSCLC [ Time Frame: 7 days ]
    Frequencies of CD3+, CD4+, CD45RO and Foxp3+ T cells in resected NSCLC tumors determined by immunohistochemistry and flow cytometry


Other Outcome Measures:
  1. Tumor reactive T cells [ Time Frame: 3 months ]
    Frequencies of tumor reactive T cells in blood and bone marrow before radiotherapy and after surgery


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319408


Locations
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Germany
Department of Thoracic Surgery, Thoraxklinik, University Hospital Heidelberg
Heidelberg, Germany, 69126
German Cancer Research Centre and Clinic for Radiation Oncology of the University of Heidelberg
Heidelberg, Germany, 69126
Sponsors and Collaborators
University Hospital Heidelberg
German Cancer Research Center
Heidelberg University
Investigators
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Principal Investigator: Seyer Safi, MD, PhD University Hospital Heidelberg
Principal Investigator: Hans Hoffmann, MD, PhD University Hospital Heidelberg
Principal Investigator: Peter Huber, MD, PhD German Cancer Research Centre
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Dr. med. Seyer Safi, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT02319408    
Other Study ID Numbers: S-576/ 2013
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: May 2022
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms