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| ID | Type | Description | Link |
|---|---|---|---|
| KRDI-TUM-STRATEGIE-STR-242-LOR | |||
| EU-20659 |
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RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving stereotactic radiation therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving stereotactic radiation therapy together with combination chemotherapy works in treating patients undergoing surgery for locally advanced pancreatic cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE:
After completion of study treatment, patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine hydrochloride | Drug | |||
| oxaliplatin | Drug | |||
| adjuvant therapy | Procedure | |||
| neoadjuvant therapy | Procedure | |||
| hypofractionated radiation therapy | Radiation | |||
| stereotactic radiosurgery | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response rate as assessed by RECIST criteria |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity as assessed by NCI-CTC criteria | ||
| Time to progression | ||
| Time to death |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas or intrapancreatic bile duct carcinoma
Locally advanced disease, meeting 1 of the following criteria:
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 1 cm by spiral CT scan or MRI
No distant metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Florian Lordick, MD | Technical University of Munich | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Rechts Der Isar - Technische Universitaet Muenchen | Munich | D-81675 | Germany |
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| Perioperative morbidity and mortality |
| Rate of R0 resections |
| Histologic response rate |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| D017024 | Chemotherapy, Adjuvant |
| D020360 | Neoadjuvant Therapy |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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