Ignite Creation Date:
2024-05-06 @ 7:44 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02591030
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2015-10-26
Brief Title:
Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Randomised Phase IIIII Study Assessing the Safety and Efficacy of Modified Folfirinox Versus Gemcis in Locally Advanced Unresectable andor Metastatic Bile Duct Tumours
Status:
COMPLETED
Status Verified Date:
2022-02
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:
AMEBICA
Brief Summary:
Bile duct tumours are rare They are the 6th most common type of digestive cancer Their therapeutic management is complex and must be multidisciplinary in nature Most of the time an endoscopic or radiological biliary drainage is necessary before any tumour treatment
Their prognosis is poor due to the fact that they are normally diagnosed late which makes curative surgery impossible A population study in the Côte dOr region of France reported a survival rate at 5 years of approximately 10
For the locally advanced or metastatic forms treatment has not been properly codified With respect to chemotherapy prospective studies most often phase II are difficult to interpret due to a limited number of patients and due to the heterogeneity of this type of tumour bile duct and pancreas tumours Treatment with 5FU alone provides an objective response in approximately 10 of cases In combination with mitomycin or carboplatin the objective response rate is 20 with a median survival period of 5 months Interferon combined with 5FU has a better response rate 30 but occurrences of different types of toxicity are more frequent
More recently gemcitabine and the 5FU-cisplatin combinations demonstrated objective tumour control in 50 of patients with a median survival period of 10 months Gemcitabine combined with oxiplatin or with cisplatin has shown the same response rate but a median survival period of approximately 12 months
The benefit of this combination has been confirmed in a phase III trial that compared the gemcitabine-cisplatin combination to gemcitabine alone in 410 patients with locally advanced unresectable andor metastatic bile duct cancer The results were in favour of the combined treatment with a median survival period of 117 months versus 81 months - HR 064 052 - 080 This combination is currently the reference first-line treatment
Their prognosis is poor due to the fact that they are normally diagnosed late which makes curative surgery impossible A population study in the Côte dOr region of France reported a survival rate at 5 years of approximately 10
For the locally advanced or metastatic forms treatment has not been properly codified With respect to chemotherapy prospective studies most often phase II are difficult to interpret due to a limited number of patients and due to the heterogeneity of this type of tumour bile duct and pancreas tumours Treatment with 5FU alone provides an objective response in approximately 10 of cases In combination with mitomycin or carboplatin the objective response rate is 20 with a median survival period of 5 months Interferon combined with 5FU has a better response rate 30 but occurrences of different types of toxicity are more frequent
More recently gemcitabine and the 5FU-cisplatin combinations demonstrated objective tumour control in 50 of patients with a median survival period of 10 months Gemcitabine combined with oxiplatin or with cisplatin has shown the same response rate but a median survival period of approximately 12 months
The benefit of this combination has been confirmed in a phase III trial that compared the gemcitabine-cisplatin combination to gemcitabine alone in 410 patients with locally advanced unresectable andor metastatic bile duct cancer The results were in favour of the combined treatment with a median survival period of 117 months versus 81 months - HR 064 052 - 080 This combination is currently the reference first-line treatment
Detailed Description:
At the same time as these results triple therapies involving 5FU oxiplatin irinotecan have objectively shown a significant increase in overall survival of patients with metastatic pancreatic adenocarcinoma compared to gemcitabine alone median of 111 months versus 68 months HR 057 045 - 073 p 00001 The response rate and progression-free survival PFS have also been improved with these triple therapies the response rates were 316 versus 94 p 0001 and the median PFS 64 months versus 33 months p 0001 respectively
The adverse events observed with the triple therapy occurred more frequently for febrile neutropaenia 54 with the need to treat with growth factors G-CSF for 425 of patients Haematological and digestive toxicity was also higher grade 3-4 neutropaenia was observed for 457 of patients in the FOLFIRINOX arm and 187 of patients in the gemcitabine arm p 00001 vomiting was noted for 145 of patients in the FOLFIRINOX arm and 47 in the gemcitabine arm p 0002 Quality of life was improved in the FOLFIRINOX arm
Due to the histological therapeutic and prognostic similarities between pancreatic and bile duct cancer it is interesting to assess this triple therapy compared to the current reference treatment in bile duct cancers gemcitabine combined with cisplatin GEMCIS Due to the known higher levels of toxicity for this triple therapy digestive and haematological the investigators modified the conventional FOLFIRINOX regimen mFOLFIRINOX by removing the 5-FU bolus at D1 of each cycle This modification to the regimen would appear not to decrease the efficacy of the treatment
The adverse events observed with the triple therapy occurred more frequently for febrile neutropaenia 54 with the need to treat with growth factors G-CSF for 425 of patients Haematological and digestive toxicity was also higher grade 3-4 neutropaenia was observed for 457 of patients in the FOLFIRINOX arm and 187 of patients in the gemcitabine arm p 00001 vomiting was noted for 145 of patients in the FOLFIRINOX arm and 47 in the gemcitabine arm p 0002 Quality of life was improved in the FOLFIRINOX arm
Due to the histological therapeutic and prognostic similarities between pancreatic and bile duct cancer it is interesting to assess this triple therapy compared to the current reference treatment in bile duct cancers gemcitabine combined with cisplatin GEMCIS Due to the known higher levels of toxicity for this triple therapy digestive and haematological the investigators modified the conventional FOLFIRINOX regimen mFOLFIRINOX by removing the 5-FU bolus at D1 of each cycle This modification to the regimen would appear not to decrease the efficacy of the treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2015-002282-35 | EUDRACT_NUMBER | None | None |