Gemcitabine, Cisplatin, and Radiation Therapy Followed By Surgery or Surgery Alone in Treating Patients With Localized Pancreatic Cancer That Can Be Removed By Surgery
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet know whether giving chemotherapy together with radiation therapy before surgery is more effective than surgery alone in treating pancreatic cancer.
PURPOSE: This randomized phase II trial is studying how well giving gemcitabine and cisplatin together with radiation therapy before surgery works compared to surgery alone in treating patients with localized pancreatic cancer that can be removed by surgery.
Drug: gemcitabine hydrochloride
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Preoperative Chemoradiation in Locally Resectable Adenocarcinoma of Pancreatic Head Without Metastasis|
- Median survival [ Designated as safety issue: No ]
- 3-year survival rate [ Designated as safety issue: No ]
- R0 resection rate [ Designated as safety issue: No ]
- Rate of medium and high toxicity events [ Designated as safety issue: Yes ]
- Rate of complete and incomplete remission of the tumor as measured by radiographic imaging studies [ Designated as safety issue: No ]
- Rate of different regression gradings in resected tumor specimens [ Designated as safety issue: No ]
- Quality of life before, during, and after therapy [ Designated as safety issue: No ]
|Study Start Date:||June 2003|
|Study Completion Date:||October 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
- Determine whether neoadjuvant chemoradiotherapy comprising gemcitabine hydrochloride, cisplatin, and radiotherapy is better than immediate surgery, in terms of median survival, in patients with locally resectable adenocarcinoma of the pancreatic head.
- Compare 3-year survival rate in patients treated with these regimens.
- Compare R0 resection rate in these patients.
- Compare the rate of medium and high toxicity events in these patients.
- Compare the rate of complete and incomplete remission of the tumor as measured by radiographic imaging studies.
- Compare the rate of different regression gradings in resected tumor specimens.
- Compare the quality of life of these patients.
OUTLINE: This is a prospective, randomized, controlled, open-label, multicenter study. Patients are stratified according to participating center and staging laparoscopy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, 22, and 29. Patients also undergo radiotherapy to the tumor and surrounding lymph nodes 5 days a week for 5 weeks followed by 3 more doses of radiotherapy directly to the tumor. Approximately 6 weeks after finishing chemoradiotherapy, patients with no evidence of disease progression undergo surgery to remove the tumor.
- Arm II: Patients undergo surgery to remove the tumor. After surgery, all patients receive adjuvant chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at the end of chemotherapy and before surgery (arm I), and then at 6 weeks, 6 months, 12 months, and 24 months after surgery.
After completion of study treatment, patients are followed every 3 months for 2 years and then at 3 years.
PROJECTED ACCRUAL: A total of 254 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335543
|Innsbruck, Austria, A-6020|
|Allgemeines Krankenhaus - Universitatskliniken|
|Vienna, Austria, A-1090|
|Robert Roessle Comprehensive Cancer Center - Charite Campus Buch|
|Berlin, Germany, D-13125|
|Bochum, Germany, D-44892|
|DIAKO Ev. Diakonie Krankenhaus gGmbH|
|Bremen, Germany, D-28239|
|Krankenhaus Dresden - Friedrichstadt|
|Dresden, Germany, D-01008|
|Erlangen, Germany, D-91054|
|Arbeitsgruppe Lebermetastasen und Tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie|
|Frankfurt, Germany, 60590|
|Klinik am Eichert|
|Goeppingen, Germany, D-73035|
|Heidelberg, Germany, D-69120|
|Leipzig, Germany, D-04103|
|Staedtisches Klinikum Magdeburg|
|Magdeburg, Germany, D-39130|
|Klinikum der Universitaet Muenchen - Grosshadern Campus|
|Munich, Germany, D-81377|
|Klinikum Nuernberg - Klinikum Nord|
|Nuremberg, Germany, D-90419|
|Klinikum der Universitaet Regensburg|
|Regensburg, Germany, D-93053|
|Tuebingen, Germany, D-72076|
|Kantonsspital - St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|Study Chair:||W. Hohenberger, MD||Universitaet Erlangen|