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| Name | Class |
|---|---|
| Heidelberg University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0 | No Intervention | primarily resectable pancreatic cancer patients | |
| 0,5 Gy | Active Comparator | neoadjuvant Radiation of 0,5 Gy two days before resection |
|
| 2 Gy | Active Comparator | neoadjuvant Radiation of 2 Gy 2 days before resection |
|
| 5 Gy | Active Comparator | neoadjuvant Radiation of 5 Gy 2 days before resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neoadjuvant photon radiation | Radiation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 years |
| surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter E. Huber, Prof. PhD MD | German Cancer Research Centre and Clinic for Radiation Oncology of the University of Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for General, Visceral and Transplantation Surgery | Heidelberg | 69120 | Germany | |||
| German Cancer Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21489291 | Derived | 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. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| neoadjuvant photon radiation | Radiation | single fraction, 4D-planned, image guided, 2 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection |
|
| neoadjuvant photon radiation | Radiation | single fraction, 4D-planned, image guided, 5 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection |
|
surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment |
| 1 year |
| frequencies of tumor-reactive T-cells in blood and bone marrow | frequencies of tumor-reactive T-cells in blood and bone marrow | 2 years |
| expression of migration-relevant adhesion molecules on tumor endothelial cells | expression of migration-relevant adhesion molecules on tumor endothelial cells | 2 years |
| 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 | 2 years |
| 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 | 3 years |
| Heidelberg |
| 69120 |
| Germany |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |