Low Dose Radiation to Improve T-Cell Infiltration in Pancreatic Cancer (IMPACT2010)
Primary Purpose
Primarily Resectable Pancreatic Cancer
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
neoadjuvant photon radiation
neoadjuvant photon radiation
neoadjuvant photon radiation
Sponsored by
About this trial
This is an interventional treatment trial for Primarily Resectable Pancreatic Cancer focused on measuring Low Dose Radiation, pancreatic cancer, Immunostimulation
Eligibility Criteria
Inclusion Criteria:
- Radiological diagnosis of resectable pancreatic carcinoma is required prior to treatment. Potentially resectable is defined as no extrapancreatic disease, no evidence (on CT) of involvement of the celiac axis or superior mesenteric artery, no evidence (on CT or MRI) of occlusion of the superior mesenteric vein or superior mesenteric-portal venous confluence.
- No evidence of metastatic disease as determined by chest CT scan, abdominal CT scan (or MRI)
- 18 years of age or older
- American Society of Anesthesiologists (ASA)- Performance status of 1 to 3
- Women of child bearing potential must practice adequate contraception and refrain from breast feeding. Female patients must have a negative pregnancy test within 7 days of treatment
- Informed consent
Exclusion Criteria:
- Locally irresectable pancreatic cancer
- distant metastases
- medically unfit for surgery
- Pregnant or lactating women
- prior chemotherapy or radiation treatment
- Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
- Unwillingness to participate or inability to comply with the protocol for the duration of the study
- Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
- Participation in other interventional trials
Sites / Locations
- Clinic for General, Visceral and Transplantation Surgery
- German Cancer Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
Active Comparator
Active Comparator
Arm Label
0
0,5 Gy
2 Gy
5 Gy
Arm Description
primarily resectable pancreatic cancer patients
neoadjuvant Radiation of 0,5 Gy two days before resection
neoadjuvant Radiation of 2 Gy 2 days before resection
neoadjuvant Radiation of 5 Gy 2 days before resection
Outcomes
Primary Outcome Measures
Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumoral activity
Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumoral activity
Secondary Outcome Measures
local control and recurrence patterns of pancreatic cancer relative to a standard as seen in historical controls
local control and recurrence patterns of pancreatic cancer relative to a standard as seen in historical controls
surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment
surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment
frequencies of tumor-reactive T-cells in blood and bone marrow
frequencies of tumor-reactive T-cells in blood and bone marrow
expression of migration-relevant adhesion molecules on tumor endothelial cells
expression of migration-relevant adhesion molecules on tumor endothelial cells
expression of proinflammatory cytokines and activation-dependent, immune-associated transcriptionally factors in tumors and blood
expression of proinflammatory cytokines and activation-dependent, immune-associated transcriptionally factors in tumors and blood
quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months
quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months
Full Information
NCT ID
NCT01027221
First Posted
December 4, 2009
Last Updated
June 7, 2021
Sponsor
German Cancer Research Center
Collaborators
Heidelberg University
1. Study Identification
Unique Protocol Identification Number
NCT01027221
Brief Title
Low Dose Radiation to Improve T-Cell Infiltration in Pancreatic Cancer
Acronym
IMPACT2010
Official Title
Randomised Phase I/II Trial in Order to Evaluate the Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Neoadjuvant Low-Dose-Radiation Therapy in Primarily Resectable Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
November 2009 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German Cancer Research Center
Collaborators
Heidelberg University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximum number of tumor infiltrating T-cells.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primarily Resectable Pancreatic Cancer
Keywords
Low Dose Radiation, pancreatic cancer, Immunostimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0
Arm Type
No Intervention
Arm Description
primarily resectable pancreatic cancer patients
Arm Title
0,5 Gy
Arm Type
Active Comparator
Arm Description
neoadjuvant Radiation of 0,5 Gy two days before resection
Arm Title
2 Gy
Arm Type
Active Comparator
Arm Description
neoadjuvant Radiation of 2 Gy 2 days before resection
Arm Title
5 Gy
Arm Type
Active Comparator
Arm Description
neoadjuvant Radiation of 5 Gy 2 days before resection
Intervention Type
Radiation
Intervention Name(s)
neoadjuvant photon radiation
Intervention Description
single fraction, four dimensions (4D) planned, image guided, Radiation at a dose of 0,5 Gy in Intensity modulated radiotherapy (IMRT)-technique 2 days before resection
Intervention Type
Radiation
Intervention Name(s)
neoadjuvant photon radiation
Intervention Description
single fraction, 4D-planned, image guided, 2 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection
Intervention Type
Radiation
Intervention Name(s)
neoadjuvant photon radiation
Intervention Description
single fraction, 4D-planned, image guided, 5 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection
Primary Outcome Measure Information:
Title
Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumoral activity
Description
Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumoral activity
Time Frame
1 year
Secondary Outcome Measure Information:
Title
local control and recurrence patterns of pancreatic cancer relative to a standard as seen in historical controls
Description
local control and recurrence patterns of pancreatic cancer relative to a standard as seen in historical controls
Time Frame
5 years
Title
surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment
Description
surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment
Time Frame
1 year
Title
frequencies of tumor-reactive T-cells in blood and bone marrow
Description
frequencies of tumor-reactive T-cells in blood and bone marrow
Time Frame
2 years
Title
expression of migration-relevant adhesion molecules on tumor endothelial cells
Description
expression of migration-relevant adhesion molecules on tumor endothelial cells
Time Frame
2 years
Title
expression of proinflammatory cytokines and activation-dependent, immune-associated transcriptionally factors in tumors and blood
Description
expression of proinflammatory cytokines and activation-dependent, immune-associated transcriptionally factors in tumors and blood
Time Frame
2 years
Title
quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months
Description
quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Radiological diagnosis of resectable pancreatic carcinoma is required prior to treatment. Potentially resectable is defined as no extrapancreatic disease, no evidence (on CT) of involvement of the celiac axis or superior mesenteric artery, no evidence (on CT or MRI) of occlusion of the superior mesenteric vein or superior mesenteric-portal venous confluence.
No evidence of metastatic disease as determined by chest CT scan, abdominal CT scan (or MRI)
18 years of age or older
American Society of Anesthesiologists (ASA)- Performance status of 1 to 3
Women of child bearing potential must practice adequate contraception and refrain from breast feeding. Female patients must have a negative pregnancy test within 7 days of treatment
Informed consent
Exclusion Criteria:
Locally irresectable pancreatic cancer
distant metastases
medically unfit for surgery
Pregnant or lactating women
prior chemotherapy or radiation treatment
Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
Unwillingness to participate or inability to comply with the protocol for the duration of the study
Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
Participation in other interventional trials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter E. Huber, Prof. PhD MD
Organizational Affiliation
German Cancer Research Centre and Clinic for Radiation Oncology of the University of Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic for General, Visceral and Transplantation Surgery
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
German Cancer Research Center
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
21489291
Citation
Timke C, Winnenthal HS, Klug F, Roeder FF, Bonertz A, Reissfelder C, Rochet N, Koch M, Tjaden C, Buechler MW, Debus J, Werner J, Beckhove P, Weitz J, Huber PE. Randomized controlled phase I/II study to investigate immune stimulatory effects by low dose radiotherapy in primarily operable pancreatic cancer. BMC Cancer. 2011 Apr 13;11:134. doi: 10.1186/1471-2407-11-134.
Results Reference
derived
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Low Dose Radiation to Improve T-Cell Infiltration in Pancreatic Cancer
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