A Phase 2 interventional study of cisplatin and docetaxel in Pancreatic Cancer, sponsored by UNICANCER. Completed at 10 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-02-17.
Sponsored by UNICANCER · Phase 2, Interventional, and Treatment
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy, docetaxel, and fluorouracil are more effective than radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic cancer.
PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and fluorouracil to see how well they work as first-line therapy compared to radiation therapy, docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
In both arms, patients experiencing disease progression after completion of chemoradiotherapy may receive additional courses of chemotherapy.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 3 years.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 71 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →UNICANCER is the lead sponsor of 215 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
No other pancreatic tumor type, including either of the following:
Unresectable disease, defined as either of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Drug: docetaxel · Drug: fluorouracil · Radiation: radiation therapy
Drug: cisplatin · Drug: docetaxel · Radiation: radiation therapy
Progression-free survival rate at 6 months
Toxicity
Objective response rate
Overall survival
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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UNICANCER