ABC-02 regime - gemcitabine and cisplatin with a shortened hydration time and administration of a newer antiemetic

ABC-02 regime - gemcitabine and cisplatin with currently approved hydration time and administration of the current choice of antiemetic

Gallbladder Cancer

Hydration is reduced to 1 hour and 40 minutes and Akynzeo is administered as an oral drug instead of Ondansetron being given as an IV before chemotherapy.

Shortened hydration time and dispensary of Akynzeo

Hydration remains at around 6 hours and 30 minutes due to no oral fluids being consumed prior to treatment and normal saline being administered for 90 minutes before cisplatin and then for 2 hours after cisplatin and before gemcitabine administration

Standard of care

Imperial College Healthcare NHS Trust

Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration

A Prospective Study of Tolerance Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration

To compare the proportion of patients who experience CTCAE V3.0 grade 3 or 4 nausea (using a shortened hydration protocol and a modern antiemetic regimen) with those who are in the ABC02 trial arm which used a longer hydration procedure and a standard antiemetic regimen

To compare proportion of patients who experience CTCAE V3.0 grade 3 or 4 impaired renal function

To compare proportion of patients who have a complete response i.e. no nausea and vomiting recorded as a toxicity

To compare the proportion of patients who experience renal dysfunction (a deterioration of calculated GFR of below 60)

To determine the incidence of early and delayed chemotherapy induced emesis using the MAT antiemesis tool

To determine the incidence of nocturia in the first night after chemotherapy

Measuring the length of hospital visit (time in to time out) for each patient per treatment visit and comparing the difference between arms

Chugai Pharma UK Limited

D1 Oxaliplatin 65 mg/m2 + 5% dextrose water (5DW) 200 mL mix IV over 2 hours followed by, D1 Leucovorin 400 mg/m2 + 5DW 200 ml mix IV over 2 hours D1 Irinotecan 135 mg/m2 + 5DW 500 mL mix IV over 2 hours (concurrent with the leucovorin infusion) D1-2 5-Fluorouracil 1000 mg/m2 + 5DW 1 liter (1L) continuous IV over 23 hours repeat every 2 weeks

Biliary Tract Cancer

D1-2 5-Fluorouracil 1000 mg/m2 + 5DW 1L continuous IV over 23 hours q 2 weeks

5-Fluorouracil

D1 Leucovorin 400 mg/m2 + 5DW 200 ml mix IV over 2 hours q 2 weeks

Leucovorin

D1 Irinotecan 135 mg/m2 + 5DW 500 mL mix IV over 2 hours (concurrent with the leucovorin infusion) q 2weeks

Irinotecan

D1 Oxaliplatin 65 mg/m2 + 5DW 200 mL mix IV over 2 hours q 2 weeks

Oxaliplatin

FOLFIRINOX for 2nd-line Treatment of BTC

Phase II Trial of Modified FOLFIRINOX in Patients With Metastatic Biliary Tract Cancer After Failure of Gemcitabine/Cisplatin Chemotherapy

Rate of response including complete response and partial response by treatment

duration measure from treatment day to progression + death events

duration measure from treatment day to death events

Evaluate patients' life quality evaluation during treatment every 2 months with questionaires

Sung Yong Oh

Associate Professor

Dong-A University Hospital

mFOLFIRINOX (5-FU, Irinotecan, oxaliplatin, Leucovorin)

Bile Duct Cancer

At D1 and D8 of each cycle, i.e. every 21 days for 6 months:
Cisplatin 25 mg/m² over 1 hour at D1 and D8
Gemcitabine 1000 mg/m² over 30 minutes at D1 and D8.

GEMCIS

At D1 of each cycle, i.e. every 15 days for 6 months:
Oxiplatin: 85 mg/m² (IP/120 minutes)
Irinotecan: 180 mg/m² (IV/90 minutes)
Folinic acid: 400 mg/m² (or 200 mg/m² if Elvorine [calcium levofolinate]) (IV/2 hours), via a Y connector at the same time as irinotecan
5-FU: 2400 mg/m² (IV over 46 hours) without 5FU bolus at D1

mFolfirinox

Chu Picardie

Ico Paul Papin

CH Victor Dupouy

CH de la Côte Basque

CHRU Besançon

Hôpital Avicenne

Hôpital Saint-André

Polyclinique Nord

Hôpital Duchenne

Centre François Baclesse

Chu D'Estaing

Hôpitaux Civils

Ch Sud Francilien

Centre de radiothérapie et oncologie du Parc

Centre Georges François Leclerc

Hôpital Michallon

CHD Vendée

Clinique du cap d'Or

CH Le Kremlin Bicetre

CHRU Lille

Centre Hospitalier de Longjumeau

Clinique de la Sauvegarde

Centre Léon Bérard

Hôpital de la Croix Rousse

Hôpital Lyon Sud

Hôpital Saint-Joseph

Centre Catherine de Sienne

CHR Orléans

HEGP

Hôpital Cochin

Hôpital Saint-Jean

CHU La Miletrie

CHU Reims

Centre Eugène Marquis

Hôpital Drôme Nord

Chu Rouen

CHU Saint-Etienne

CH Saint-Jean de Luz

CH Saint-Quentin

Ch Robert Morlevat

CAC Paul Strauss

CHU Tours

Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours

Randomised Phase II/III Study, Assessing the Safety and Efficacy of Modified Folfirinox Versus Gemcis in Locally Advanced, Unresectable and/or Metastatic Bile Duct Tumours

In phase II, the primary endpoint is the percentage of patients alive without radiological progression (assessed according to the RECIST v1.1 criteria) at 6 months (after randomisation).
Patients who are in radiological progression or who have died before the 6 months have elapsed will be considered a failure for the primary endpoint at 6 months (after randomisation).
A medical review will be conducted to decide on patients without radiological progression at 6 months; in the light of their entire medical file, they may be considered a failure (i.e. in progression) or they may be considered to be truly non-assessable (a 5% surplus of patients has been planned for this situation).

In phase III, the primary endpoint is overall survival. This is defined as the period between the date of randomisation and the date of death (regardless of the cause). Patients who are lost to follow-up will be censored at the end-point for the analysis, or at the date when they were last heard of.

In phase II, this is defined as the period between the date of randomisation and the date of death (regardless of the cause). Patients who are lost to follow-up will be censored at the end-point for the analysis, or at the date when they were last heard of.

In phase II, the best tumour response will be assessed across all the treatments and will be described using the figures for the different categories: complete response, partial response, stable, progression or non-assessable.

In phase III, the best tumour response will be assessed across all the treatments and will be described using the figures for the different categories: complete response, partial response, stable, progression or non-assessable.

In phase II, different types of toxicity assessed according to NCI-CTC v 4.0. Type of toxicity : Haematological (platelets and Neutrophils), Non-haematological (except for nausea, vomiting and alopecia) and neurological (paraesthesia)

In phase III, different types of toxicity assessed according to NCI-CTC v 4.0. Type of toxicity : Haematological (platelets and Neutrophils), Non-haematological (except for nausea, vomiting and alopecia) and neurological (paraesthesia)

In phase III : angiocholitis, obstruction of the main bile ducts or biliary stent obstruction

In phase II : angiocholitis, obstruction of the main bile ducts or biliary stent obstruction

EORTC QLQ-C30 quality of life. Quality-of-life assessments will be performed until progression of the disease

Centre Hospitalier Universitaire de Saint Etienne

Federation Francophone de Cancerologie Digestive

Patients scheduled for percutaneous drainage

Patients scheduled for a surgical bypass or resection of a high bile duct tumor.

Liver Cancer

complete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure.

questionnaires

complete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure. Patients who have undergone bypass or resection will complete an additional set of questionnaires at 9 and 14 weeks.

cholangiocarcinoma/wymioty

Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration

FOLFIRINOX for 2nd-line Treatment of BTC

Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours

Quality Of Life in Patients With Malignant Biliary Obstruction

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