Immune Boost In Non-Small Cell Lung Cancer (RadImmune)
Primary Purpose
Non-small Cell Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Preoperative radiation
Sponsored by
About this trial
This is an interventional basic science trial for Non-small Cell Lung Cancer
Eligibility 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
Sites / Locations
- Department of Thoracic Surgery, Thoraxklinik, University Hospital Heidelberg
- German Cancer Research Centre and Clinic for Radiation Oncology of the University of Heidelberg
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No radiation
Preoperative radiation
Arm Description
Lobectomy for lung cancer without preoperative radiation
Lobectomy for lung cancer with preoperative radiation
Outcomes
Primary Outcome Measures
Cluster of differentiation (CD)8+ T cells in resected NSCLC
Frequencies of CD8+ T cells in resected NSCLC tumors determined by immunohistochemistry
Secondary Outcome Measures
T cell subtypes in resected NSCLC
Frequencies of CD3+, CD4+, CD45RO and Foxp3+ T cells in resected NSCLC tumors determined by immunohistochemistry and flow cytometry
Full Information
NCT ID
NCT02319408
First Posted
May 27, 2014
Last Updated
May 16, 2022
Sponsor
University Hospital Heidelberg
Collaborators
German Cancer Research Center, Heidelberg University
1. Study Identification
Unique Protocol Identification Number
NCT02319408
Brief Title
Immune Boost In Non-Small Cell Lung Cancer
Acronym
RadImmune
Official Title
A Randomized Phase II Study of Radiation Induced Immune Boost in Operable Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Heidelberg
Collaborators
German Cancer Research Center, Heidelberg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No radiation
Arm Type
No Intervention
Arm Description
Lobectomy for lung cancer without preoperative radiation
Arm Title
Preoperative radiation
Arm Type
Experimental
Arm Description
Lobectomy for lung cancer with preoperative radiation
Intervention Type
Radiation
Intervention Name(s)
Preoperative radiation
Intervention Description
Lobectomy for lung cancer following preoperative radiation
Primary Outcome Measure Information:
Title
Cluster of differentiation (CD)8+ T cells in resected NSCLC
Description
Frequencies of CD8+ T cells in resected NSCLC tumors determined by immunohistochemistry
Time Frame
7 days
Secondary Outcome Measure Information:
Title
T cell subtypes in resected NSCLC
Description
Frequencies of CD3+, CD4+, CD45RO and Foxp3+ T cells in resected NSCLC tumors determined by immunohistochemistry and flow cytometry
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Tumor reactive T cells
Description
Frequencies of tumor reactive T cells in blood and bone marrow before radiotherapy and after surgery
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyer Safi, MD, PhD
Organizational Affiliation
University Hospital Heidelberg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans Hoffmann, MD, PhD
Organizational Affiliation
University Hospital Heidelberg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Huber, MD, PhD
Organizational Affiliation
German Cancer Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Thoracic Surgery, Thoraxklinik, University Hospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
German Cancer Research Centre and Clinic for Radiation Oncology of the University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24209604
Citation
Klug F, Prakash H, Huber PE, Seibel T, Bender N, Halama N, Pfirschke C, Voss RH, Timke C, Umansky L, Klapproth K, Schakel K, Garbi N, Jager D, Weitz J, Schmitz-Winnenthal H, Hammerling GJ, Beckhove P. Low-dose irradiation programs macrophage differentiation to an iNOS(+)/M1 phenotype that orchestrates effective T cell immunotherapy. Cancer Cell. 2013 Nov 11;24(5):589-602. doi: 10.1016/j.ccr.2013.09.014. Epub 2013 Oct 24.
Results Reference
background
PubMed Identifier
26686362
Citation
Safi S, Beckhove P, Warth A, Benner A, Roeder F, Rieken S, Debus J, Dienemann H, Hoffmann H, Huber PE. A randomized phase II study of radiation induced immune boost in operable non-small cell lung cancer (RadImmune trial). BMC Cancer. 2015 Dec 19;15:988. doi: 10.1186/s12885-015-2006-2.
Results Reference
result
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Immune Boost In Non-Small Cell Lung Cancer
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