Ignite Creation Date:
2024-05-05 @ 11:17 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01297998
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2011-02-07
Brief Title:
A Phase I Study of Adjuvant Chemotherapy With GC in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy
Sponsor:
Kansai Hepatobiliary Oncology Group
Organization:
Kansai Hepatobiliary Oncology Group
Study Overview
Official Title:
A Phase I Study of Adjuvant Chemotherapy With Gemcitabine Plus Cisplatin in Patients With Biliary Tract Cancer Undergoing Curative Resection Without Major Hepatectomy
Status:
COMPLETED
Status Verified Date:
2014-06
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:
To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus cisplatin combination therapy in patients with biliary tract cancer undergoing resection without major hepatectomy
Detailed Description:
Surgery currently remains the only potentially curative treatment for biliary tract cancer BTC and most patients develop recurrence Therefore effective adjuvant chemotherapy is required to increase the curability of surgery and to prolong the survival in these patients However to date no standard adjuvant chemotherapy has been established and a guideline for BTC treatment recommends that trials of adjuvant chemotherapy be carried out
Based on results from clinical studies in unresectable BTC gemcitabine platinum agent fluoropyrimidine are considered to have activity against BTC These agents are expected to be effective in the postoperative adjuvant therapy for BTC Thus randomized controlled trials with gemcitabine are ongoing and the results are expected Recently in the ABC-02 study the first prospective multicenter phase III study in patients with unresectable BTC gemcitabinecisplatin combination chemotherapy was compared with gemcitabine monotherapy and showed that the combination therapy significantly prolonged MST from 81 to 117 months P 0001 Gemcitabinecisplatin combination therapy is now considered to be the standard regimen for unresectable BTC and we expect this regimen to be effective for postoperative adjuvant therapy
Though hepatectomy is frequently performed in surgery for BTC it is unclear that the effect of anticancer agent is affected by hepatectomy Because gemcitabine is metabolized by cytidine deaminase primarily in the liver it considered to have decreased the metabolic ability of gemcitabine after hepatectomy Some clinical studies demonstrated that patient with hepatectomy could not tolerate the standard dose and schedule of gemcitabine In the adjuvant chemotherapy with gemcitabine it is necessary to examine separately whether hepatectomy was undergone or not
In this study we aimed to assess the safety and efficacy of gemcitabinecisplatin combination chemotherapy in patients with biliary tract cancer undergoing curative resection without hepatectomy
Based on results from clinical studies in unresectable BTC gemcitabine platinum agent fluoropyrimidine are considered to have activity against BTC These agents are expected to be effective in the postoperative adjuvant therapy for BTC Thus randomized controlled trials with gemcitabine are ongoing and the results are expected Recently in the ABC-02 study the first prospective multicenter phase III study in patients with unresectable BTC gemcitabinecisplatin combination chemotherapy was compared with gemcitabine monotherapy and showed that the combination therapy significantly prolonged MST from 81 to 117 months P 0001 Gemcitabinecisplatin combination therapy is now considered to be the standard regimen for unresectable BTC and we expect this regimen to be effective for postoperative adjuvant therapy
Though hepatectomy is frequently performed in surgery for BTC it is unclear that the effect of anticancer agent is affected by hepatectomy Because gemcitabine is metabolized by cytidine deaminase primarily in the liver it considered to have decreased the metabolic ability of gemcitabine after hepatectomy Some clinical studies demonstrated that patient with hepatectomy could not tolerate the standard dose and schedule of gemcitabine In the adjuvant chemotherapy with gemcitabine it is necessary to examine separately whether hepatectomy was undergone or not
In this study we aimed to assess the safety and efficacy of gemcitabinecisplatin combination chemotherapy in patients with biliary tract cancer undergoing curative resection without hepatectomy
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 |
|---|---|---|---|
| UMIN000004622 | REGISTRY | UMIN | None |