Esophageal cancer
Conditions
Interventions
We add weekly paclitacel administration to triweekly 5-Fulorouracl 800mg/m2+ CDDP 80mg/m2. The starting dose of paclitaxel is 40mg/m2. If torelable, we increase doses of paclitaxel from 40mg/m2 to 60m
Sponsors
Nippon Medical School Musashi Kosugi Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)A histologically confirmed diagnosis of gastric, gastroesophageal, or esophageal carcinoma. 2) Clinical stage IB, II, III, and IV(UICC-TNM) 3) Age 18 to 75 years 4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 5) Previous chemotherapy is allowed, but limited only one resimen contained of platinum and the last chemotheapy was carried out in more than six months ago. 6) Sufficient organ function 7) Peripheral neuropathy less than CTCAE-Grade 1 8) Patients who provided written informed consent by themselves in principle to participate in this trial.
Exclusion criteria
Exclusion criteria: Poor control DM, active other cancer, the past history of hyper sensitivity of study drugs, active infection, continuous use of steroid, peripheral neuropathy greater than CTCAE-Grade 2, active interstitial pneumonia, pulmonary fibrosis, psychiatric disorder, cardiopulmonary disorder(past history of angina in less than 4 weeks, myocardial infarction in less than 6 monthes, poor control congenitive heart failure), untolerable alcohol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I The maximum tolerated dose,recommended dose, and dose-limiting toxicities of weekly paclitaxel administration Phase II Response Rate of triweekly FP(5-fluorouracil plus cisplatin) and weekly paclitaxel (PCF). | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I Adverse events, and response rate of PCF Phase II Curative setting group(potentially resectable) Adverse events, pathological CR rate, progression free survival, and overall survival of PCF Palliative setting group(potentially unresectable) Adverse events, progression free survival, and overall survival of PCF | — |
Countries
Japan
Contacts
Public ContactSatoshi Nomura
Nippon Medical School Musashi Kosugi Hospital Department of Gastrointestinal Surgery
Outcome results
None listed