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L-AP-IS: Lung cancer, Ablative high Precision radiotherapy and the Immune System: Evaluation of the immune-modulatory effects of stereotactic body radiation therapy (SBRT) of pulmonary lesions

Organizational Data

DRKS-ID:
DRKS00011266
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2017-01-10
Last update in DRKS:
2020-07-29
Registration type:
Retrospective

Acronym/abbreviation of the study

L-AP-IS

URL of the study

No Entry

Brief summary in lay language

High precision radiotherapy (SBRT) leads to cell death of tumor cells, but also to specific immune response against the tumor. Main objective of this trial is to analyse potential changes of certain biomarkers of the immune response in the blood of patients who get tretaed with SBRT for lung cancer or lung metastases.

Brief summary in scientific language

The main objective of this approach is to prospectively evaluate novel and minimally invasive biomarkers of (tumor specific) immune response to SBRT in NSCLC patients, as well as in patients with solitary or oligometastatic pulmonary metastases.

Health condition or problem studied

ICD10:
C34 - Malignant neoplasm of bronchus and lung
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Blood samples of patients with primary or recurrent NSCLC collected before, during and after SBRT (Stereotactic Body RadioTherapy) will be evaluated for immunespecific, circulating biomarkers.
Arm 2:
Blood samples of patients with pulmonary metastases will be evaluated for immune-specific, circulating biomarkers.
Arm 3:
Patients with systemic treatment within 3 months before SBRT will be separately analyzed and compared to the patients who received no systemic treatment.

Endpoints

Primary outcome:
Increase of CTL counts six weeks after SBRT compared to baseline
Secondary outcome:
- Significant changes in number and phenotype of lymphocytes - Significant changes in number and phenotype of myeloid cells - Significant changes in circulating biomarkers of immune response in the plasma - Association between treatment related data and changes in different biomarkers of immune response - Association between treatment outcomes and changes in different biomarkers of immune response - Differences in the above mentioned endpoints between patients with or without prior / simultaneous radiation and /or systemic therapy

Study Design

Purpose:
Basic research/physiological study
Allocation:
Non-randomized controlled study
Control:
  • Other
Phase:
I
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Other
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Klinik für Strahlenheilkunde Freiburg im Breisgau

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2016-09-06
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
75
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
• Primary or recurrent non-metastatic NSCLC or • Solitary or oligometastasic pulmonary metastasis of otherwise controlled malignant • Lesions confirmed by either histology or cytology or clear imaging signs of malignant tumors • Patient scheduled and eligible for SBRT with curative intention • Whole body FDG-PET scan + WB-CT or CT of chest and upper abdomen • Written informed consent must be given according to ICH/GCP, and national/local regulations • Adequate birth control measures during the study treatment period

Exclusion Criteria

• Other active or significantly bone marrow suppressing malignancy • WHO performance status < 2 • Prior radiotherapy to chest and/or mediastinum within 3 months before the start of SBRT • Chemotherapy and/or targeted treatment within 3 months before the start of SBRT • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule • Pregnancy

Addresses

Primary Sponsor

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Prof. Dr. med. Anca Ligia Grosu
Robert-Koch-Str. 3
79106 Freiburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Prof. Dr. med. Anca Ligia Grosu
Robert-Koch-Str. 3
79106 Freiburg
Germany
Telephone:
+49 761 270-94610
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Prof. Dr. med. Ursula Nestle
Robert-Koch-Str. 3
79106 Freiburg
Germany
Telephone:
+49 761 270-95200
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Prof. Dr. med. Anca Ligia Grosu
Robert-Koch-Str. 3
79106 Freiburg
Germany
Telephone:
+49 761 270-94610
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Robert-Koch-Str. 3
79106 Freiburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
Telephone:
+49-761-27072600
Fax:
+49-761-27072630
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2016-05-18
Ethics committee number:
38/16
Vote of the Ethics Committee:
Approved
Date of the vote:
2016-06-16

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry