Immune Boost In Non-Small Cell Lung Cancer

NCT ID: NCT02319408

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2020-02-29

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

No radiation

Lobectomy for lung cancer without preoperative radiation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Preoperative radiation

Lobectomy for lung cancer with preoperative radiation

Group Type: EXPERIMENTAL

Preoperative radiation

Intervention Type: RADIATION

Lobectomy for lung cancer following preoperative radiation

Interventions

Preoperative radiation

Lobectomy for lung cancer following preoperative radiation

Intervention Type: RADIATION

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Cancer Research Center

OTHER

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: collaborator

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Seyer Safi

Dr. med. Seyer Safi

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seyer Safi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Hans Hoffmann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Peter Huber, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

German Cancer Research Centre

Locations

Department of Thoracic Surgery, Thoraxklinik, University Hospital Heidelberg

Heidelberg, , Germany

German Cancer Research Centre and Clinic for Radiation Oncology of the University of Heidelberg

Heidelberg, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 24209604 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26686362 (View on PubMed)

Other Identifiers

S-576/ 2013

Identifier Type: -

Identifier Source: org_study_id