Stereotactic Radiation Therapy and Combination Chemotherapy in Treating Patients Undergoing Surgery for Locally Advanced Pancreatic Cancer
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.
Drug: gemcitabine hydrochloride
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Radiation: hypofractionated radiation therapy
Radiation: stereotactic radiosurgery
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Lokal Fortgeschrittenes Pankreas-Karzinom: Stereotaktische Radiotherapie Gefolfgt Von Gemox-Chemotherapie|
- Clinical response rate as assessed by RECIST criteria [ Designated as safety issue: No ]
- Toxicity as assessed by NCI-CTC criteria [ Designated as safety issue: Yes ]
- Time to progression [ Designated as safety issue: No ]
- Time to death [ Designated as safety issue: No ]
- Perioperative morbidity and mortality [ Designated as safety issue: No ]
- Rate of R0 resections [ Designated as safety issue: No ]
- Histologic response rate [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Study Completion Date:||December 2009|
- Determine the clinical response rate in patients undergoing surgery for locally advanced pancreatic cancer treated with stereotactic radiotherapy, gemcitabine hydrochloride, and oxaliplatin.
- Determine the toxicity of this regimen in these patients.
- Determine the time to disease progression in patients treated with this regimen.
- Determine the time to death in patients treated with this regimen.
- Determine perioperative morbidity and mortality in patients treated with this regimen.
- Determine the rate of R0 resections in patients treated with this regimen.
- Determine the histologic response rate in these patients.
- Neoadjuvant therapy: Patients undergo hypofractionated, stereotactic radiotherapy on days 1-5. Patients also receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 120 minutes on day 2. Treatment with gemcitabine hydrocloride and oxaliplatin repeats every 2 weeks for 3 courses.
- Surgery: Patients with resectable disease undergo tumor resection. Patients with unresectable disease undergo a second course of neoadjuvant chemoradiotherapy followed by resection.
- Adjuvant therapy: Beginning 3-4 weeks after surgery, patients receive 3 more courses of chemotherapy as in neoadjuvant therapy.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425841
|Klinikum Rechts Der Isar - Technische Universitaet Muenchen|
|Munich, Germany, D-81675|
|Study Chair:||Florian Lordick, MD||Technische Universität München|