Ignite Creation Date:
2024-05-06 @ 1:29 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01821248
Status:
UNKNOWN
Last Update Posted:
2019-02-21
First Post:
2013-03-22
Brief Title:
A Phase II Trial of Preoperative Chemotherapy for Biliary Tract Cancer BTC With Node Metastasis
Sponsor:
Kansai Hepatobiliary Oncology Group
Organization:
Kansai Hepatobiliary Oncology Group
Study Overview
Official Title:
A Multicenter Phase II Trial of Preoperative Chemotherapy With Gemcitabine Cisplatin S-1 GCS for Biliary Tract Cancers With Lymph Node Metastasis Diagnosed by Fluorodeoxyglucose Positron Emission Tomography FDG-PET
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
To evaluate the efficacy and the safety of preoperative chemotherapy with Gemcitabine Cisplatin S-1 for biliary tract cancers with lymph node metastasis by FDG-PET
Detailed Description:
Biliary tract cancer is one of the most lethal malignancies worldwide with surgery representing the only potentially curative treatment for this disease However many patients are diagnosed as far advanced stage which is too late for curative resection and even if surgery can be performed the likelihood of relapse is very high Lymph node metastasis is the most powerful prognostic factor in biliary tract cancer which makes accurate preoperative assessment of lymph node metastasis important for indication of resection However the diagnostic accuracy sensitivity and specificity of conventional imaging techniques including computed tomography CT and magnetic resonance imaging MRI seem to be insufficient for accurate detection of lymph node metastasis Previously the investigators reported FDG-PET is useful for prediction of lymph node metastasis
On the other hand gemcitabine has been widely used to treat the patients with unresectable or recurrent biliary tract cancer In the Advanced Biliary tract Cancer ABC-02 study the first prospective multicenter phase III study in this field the combination of gemcitabinecisplatin was compared with gemcitabine monotherapy and found that the combination regimen significantly prolonged Median Survival Time MST from 81 to 117 months P 0001 Gemcitabinecisplatin combination therapy is now considered to be the standard regimen for advanced biliary tract cancer S-1 is an oral fluoropyrimidine prodrug that has confirmed efficacy against various solid tumors both alone and in combination with other cytotoxic drugs S-1 monotherapy has yielded good results against advanced biliary tract cancer and gemcitabineS-1 combination therapy has yielded promising results with acceptable toxicity levels for patients with advanced biliary tract cancer
Furthermore the investigators reported the safety and efficacy of adding S-1 to gemcitabinecisplatin combination regimen GCS for advanced biliary tract cancer
In this study the investigators evaluate the efficacy and the safety of preoperative chemotherapy with Gemcitabine Cisplatin S-1 for biliary tract cancers with lymph node metastasis by FDG-PET
On the other hand gemcitabine has been widely used to treat the patients with unresectable or recurrent biliary tract cancer In the Advanced Biliary tract Cancer ABC-02 study the first prospective multicenter phase III study in this field the combination of gemcitabinecisplatin was compared with gemcitabine monotherapy and found that the combination regimen significantly prolonged Median Survival Time MST from 81 to 117 months P 0001 Gemcitabinecisplatin combination therapy is now considered to be the standard regimen for advanced biliary tract cancer S-1 is an oral fluoropyrimidine prodrug that has confirmed efficacy against various solid tumors both alone and in combination with other cytotoxic drugs S-1 monotherapy has yielded good results against advanced biliary tract cancer and gemcitabineS-1 combination therapy has yielded promising results with acceptable toxicity levels for patients with advanced biliary tract cancer
Furthermore the investigators reported the safety and efficacy of adding S-1 to gemcitabinecisplatin combination regimen GCS for advanced biliary tract cancer
In this study the investigators evaluate the efficacy and the safety of preoperative chemotherapy with Gemcitabine Cisplatin S-1 for biliary tract cancers with lymph node metastasis by FDG-PET
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 |
|---|---|---|---|
| UMIN000009831 | REGISTRY | UMIN | None |