Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209690
Status:
COMPLETED
Last Update Posted:
2010-05-26
First Post:
2005-09-13
Brief Title:
Phase III Study of TPF as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer
Sponsor:
Hokkaido Gastrointestinal Cancer Study Group
Organization:
Hokkaido Gastrointestinal Cancer Study Group
Study Overview
Official Title:
Phase III Study of Docetaxel Cisplatin and 5-fluorouracilTPF as 1st-line Chemotherapy in Patients With Metastatic Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A phase III study is conducted to determine the maximum-tolerated dose MTD dose-limiting toxicity DLT and efficacy of a combination chemotherapy using docetaxel cisplatin and 5-fluorouracil TPF in untreated patients with metastatic esophageal cancer The usefulness of the this regimen is evaluated by response rate median survival time and progression free survival
Detailed Description:
Patients with untreated measurable metastatic esophageal cancer were included in this trial Patients received this combination chemotherapy repeated every 28 days until progression disease Starting dose dose level 1 were docetaxel 50 mgm2 on day 1 fixed dose intravenously cisplatin 15 mgm2day and continuous infusion 5-FU 800 mgm2day on day 1-4 DLT was defined as follows according to NCI-CTC version 20 Grade 4 neutropenia lasting for more than 4days Grade 4 anemia and thrombocytopenia Grade 3 neutropenia accompanied fever 38 and Grade 3 non-hematological toxicity except for nausea appetite loss general fatigue Maximal Tolerated Dose MTD is determined when the incidence of critical toxicity exceeds 50 at a certain dose level Response rate will be calculated according to RECIST criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TPF | None | None | None |