Stereotactic Radiation Therapy and Combination Chemotherapy in Treating Patients Undergoing Surgery for Locally Advanced Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT00425841|
Recruitment Status : Completed
First Posted : January 23, 2007
Last Update Posted : December 12, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: gemcitabine hydrochloride Drug: oxaliplatin Procedure: adjuvant therapy Procedure: neoadjuvant therapy Radiation: hypofractionated radiation therapy Radiation: stereotactic radiosurgery||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Masking:||None (Open Label)|
|Official Title:||Lokal Fortgeschrittenes Pankreas-Karzinom: Stereotaktische Radiotherapie Gefolfgt Von Gemox-Chemotherapie|
|Study Start Date :||May 2006|
|Actual Study Completion Date :||December 2009|
- Clinical response rate as assessed by RECIST criteria
- Toxicity as assessed by NCI-CTC criteria
- Time to progression
- Time to death
- Perioperative morbidity and mortality
- Rate of R0 resections
- Histologic response rate
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00425841
|Klinikum Rechts Der Isar - Technische Universitaet Muenchen|
|Munich, Germany, D-81675|
|Study Chair:||Florian Lordick, MD||Technische Universität München|