A Phase 2 interventional study of cisplatin and gemcitabine hydrochloride in Pancreatic Cancer, sponsored by Interdisziplinare Arbeitsgruppe Gastrointestinaler Tumore der Deutschen Krebsgesellschaft. Completed at 17 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-12.
Sponsored by Interdisziplinare Arbeitsgruppe Gastrointestinaler Tumore der Deutschen Krebsgesellschaft · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's planned enrollment of 254 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →This is the only study on the registry with Interdisziplinare Arbeitsgruppe Gastrointestinaler Tumore der Deutschen Krebsgesellschaft as lead sponsor.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreatic head
Locally resectable disease by CT scan
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Median survival
3-year survival rate
R0 resection rate
Rate of medium and high toxicity events
Rate of complete and incomplete remission of the tumor as measured by radiographic imaging studies
Rate of different regression gradings in resected tumor specimens
Quality of life before, during, and after therapy
This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.
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