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Evaluation of the intraoperative radiotherapy (IORT) in pancreatic adenocarcinoma. "IOPANCA" (IOrt in PANcreatic Cancer)

Organizational Data

DRKS-ID:
DRKS00023475
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2023-04-13
Last update in DRKS:
2023-04-13
Registration type:
Retrospective

Acronym/abbreviation of the study

IOPANCA

URL of the study

No Entry

Brief summary in lay language

Patients with pancreatic ductal adenocarcinoma (PDAC) have a poor prognosis despite the improvements made in the field of surgery, chemotherapy and radiation therapy. Even after histologically confirmed complete resection the rates of local recurrences are high, up to 75% in some studies. IORT has the potential of delivering very high doses to those areas where local recurrences frequently occur, which can be directly defined with the help of the surgeon under visual control minimizing geographic miss. The high dose is prescribed to a volume of tissue whose position, extent and depth are determined directly during the resection of the tumor.

Brief summary in scientific language

Patients with pancreatic ductal adenocarcinoma (PDAC) have a poor prognosis despite the improvements made in the field of surgery, chemotherapy and radiation therapy. Even after histologically confirmed complete resection the rates of local recurrences are high, up to 75% in some studies. IORT has the potential of delivering very high doses to those areas where local recurrences frequently occur, which can be directly defined with the help of the surgeon under visual control minimizing geographic miss. The high dose is prescribed to a volume of tissue whose position, extent and depth are determined directly during the resection of the tumor. Because of the lack of 3D imaging and imaging-based radiation planning and verification, the compliance of the dose administration is realized mainly by the intraoperative adaptation of the anatomy (e.g., shift of OARs), the choice of the appropriate applicator and the appropriate electron energy. Uncertainties in the dose delivery can often occur, as no exact dose distribution is being calculated intraoperatively as the dose is being calculated with mathematical models and tables. This might reduce the advantages of such a treatment leading to either higher toxicity rates and/or high recurrence rates. In order to validate the delivered dose we will perform in vivo TLD measurements and a three dimensional (3D) dose distribution based on intraoperative computed tomography (CBCT). Finally, a QA procedure will be defined, which will also be applied in a multi-centre study.

Health condition or problem studied

ICD10:
C25 - Malignant neoplasm of pancreas
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
iort 1x10-20 Gy

Endpoints

Primary outcome:
The documentation of the delivered dose during IORT
Secondary outcome:
Definition of a QA procedure, which should also be applied in a multi-centre study. Acute and late toxicity (≤90 days after RT is acute; late >90 days) measured as NCI-CTCAE v4.0 for adverse event reporting. Overall Survival Recurrence-free survival Patterns of local and distant recurrence Postoperative complications.

Study Design

Purpose:
Treatment
Allocation:
N/A (single arm study)
Control:
  • Uncontrolled/single arm
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Single (group)
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 UKF Klinik für Strahlenheilkunde Freiburg im Breisgau

Recruitment period and number of participants

Planned study start date:
2023-04-14
Actual study start date:
2023-03-27
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
25
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
1. Before registration, patient's written informed consent has been obtained 2. Age ≥ 18 years, male and female patients 3. Legal capacity, patient is able to understand the nature, significance, and consequences of the study 4. Surgical and medical operability 5. WHO performance status ≤ 2

Exclusion Criteria

1. Prior radiotherapy to the region(s) to be treated 2. Chemotherapy and/or targeted treatment within 2 weeks before the start of SBRT 3. Presence of infiltration of OARs such as tracheal, oesophageal infiltration or infiltration of small/large bowel or stomach 4. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study

Addresses

Primary Sponsor

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
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
Dr. med. Eleni Gkika
Robert-Koch-Str. 3
79106 Freiburg
Germany
Telephone:
0761 270 95200
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Dr. med. Eleni Gkika
Robert-Koch-Str. 3
79106 Freiburg
Germany
Telephone:
0761 270 95200
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Dr. med. Eleni Gkika
Robert-Koch-Str. 3
79106 Freiburg
Germany
Telephone:
0761 270 95200
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

IntraOp Medical Corporation
USA-94085 Sunnyvale, CA
United States
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

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:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2021-02-17
Ethics committee number:
20-1173
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-02-23

Other Address Ethics Committee

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
Telephone:
+49-761-27072600
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uniklinik-freiburg.de/ethikkommission.html

Vote of the Ethics Committee

Vote of the Ethics Committee:
Approved
Date of the vote:
2021-02-23

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
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