Adenocarcinoma of Esophagus Clinical Trial
Official title:
A Phase II Study of Doxorubicin, Cisplatin, and 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus
The purpose of this study is to collect information on the anti-tumor activity of the combination doxorubicin, cisplatin, and 5-fluorouracil when given to patients with advanced esophageal or gastric adenocarcinoma. We will also be collecting information about the side effects and safety of this combination.
- Patients will receive cisplatin and doxorubicin intravenously once every 3 weeks. In
addition to cisplatin and doxorubicin, patients will receive 5-fluorouracil
intravenously as a continuous infusion for the duration of the study. In order to do
this, patients will receive an infusion pump that can be carried with them. Treatment
cycles will be repeated every 21 days for a maximum of 8 cycles.
- Prior to enrollment in this study and while the patient is receiving the therapy,
routine blood tests and x-ryas (including chest x-rays and CT scans) will be performed
to check the body's response to the treatment. Blood tests will be checked once a week
and chest x-rays and CT scans will be checked every 6 weeks.
- Patients with progressive disease or intolerable side effects will be removed from the
study. Patients with stable disease or tumor response will continue therapy for a
maximum of 8 cycles.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02023541 -
Proton Beam Therapy to Treat Esophageal Cancer
|
Phase 1 | |
Completed |
NCT00165490 -
Combination Chemotherapy, Radiation Therapy and Surgery for Esophageal Cancer
|
Phase 2 |