Progressive well or moderately differentiated neuroendocrine tumour of the pancreas MedDRA version: 17.0 Level: LLT Classification code 10067518 Term: Pancreatic neuroendocrine tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 17.0 Level: PT Classification code 10067517 Term: Pancreatic neuroendocrine tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 1
Conditions
Interventions
Trade Name: Gluscan 600MBq/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: FLUORINE (18F) FLUDEOXYGLUCOSE
CAS Number: 105851-17-0
Concentration unit: MBq megabecquerel(s)
Concentra
Sponsors
Hôpital de Jolimont
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Has provided written informed consent prior to any study-related procedures. 2) Has a documented progressive pancreatic neuroendocrine tumour by means of imaging and based upon the RECIST 1.1 criteria for which the treating physician has decided to treat with sunitinib and lanreotide 3) Presenting a positive or negative 18-FDG PET SCAN at study entry 4) Has a World Health Organisation (WHO) performance score lower than or equal to 2. 5) Ki-67 of the tumour is documented and is below 20%. 6) Well differentiated neuroendocrine tumour according to the WHO 2000 criteria (G1 - G2) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 52 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range ;Inclusion criteria: 1) Has provided written informed consent prior to any study-related procedures. 2) Has a documented progressive pancreatic neuroendocrine tumour by means of imaging and based upon the RECIST 1.1 criteria for which the treating physician has decided to treat with sunitinib and lanreotide 3) Presenting a positive or negative 18-FDG PET SCAN at study entry 4) Has a World Health Organisation (WHO) performance score lower than or equal to 2. 5) Ki-67 of the tumour is documented and is below 20%. 6) Well differentiated neuroendocrine tumour according to the WHO 2000 criteria (G1 - G2) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 52 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range ;Inclusion criteria: 1) Has provided written informed consent prior to any study-related procedures. 2) Has a documented progressive pancreatic neuroendocrine tumour by means of imaging and based upon the RECIST 1.1 criteria for which the treating physician has decided to treat with sunitinib and lanreotide 3) Presenting a positive or negative 18-FDG PET SCAN at study entry 4) Has a World Health Organisation (WHO) performance score lower than or equal to 2. 5) Ki-67 of the tumour is documented and is below 20%. 6) Well differentiated neuroendocrine tumour according to the WHO 2000 criteria (G1 - G2) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 52 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Has previously been treated with sunitinib 2) Has been treated with somatostatin analogues (long and short acting) during the last 6 months before inclusion. 3) Is likely to require any additional concomitant treatment with anti-proliferative effect to sunitinib and lanreotide Autogel 120mg for the pancreatic neuro-endocrine tumour. 4) Has been treated with radionuclide at any time prior to study entry 5) Has a history of drug hypersensitivity with a similar chemical structure to lanreotide Autogel 120mg and/or sunitinib. 6) Is likely to require treatment during the study with drugs that are not permitted by the study protocol. 7) Is at risk of pregnancy or lactation. Females of childbearing potential must provide a negative pregnancy test at the start of study and must be using oral, double barrier or injectable contraception. Non childbearing potential is defined as post-menopausal for at least 1 year, surgical sterilization or hysterectomy at least three months before the start of the study. 8) Has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. 9) Has abnormal findings at baseline, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study. 10) Has been previously been enrolled in this study. ;Exclusion criteria: 1) Has previously been treated with sunitinib 2) Has been treated with somatostatin analogues (long and short acting) during the last 6 months before inclusion. 3) Is likely to require any additional concomitant treatment with anti-proliferative effect to sunitinib and lanreotide Autogel 120mg for the pancreatic neuro-endocrine tumour. 4) Has been treated with radionuclide at any time prior to study entry 5) Has a history of drug hypersensitivity with a similar chemical structure to lanreotide Autogel 120mg and/or sunitinib. 6) Is likely to require treatment during the study with drugs that are not permitted by the study protocol. 7) Is at risk of pregnancy or lactation. Females of childbearing potential must provide a negative pregnancy test at the start of study and must be using oral, double barrier or injectable contraception. Non childbearing potential is defined as post-menopausal for at least 1 year, surgical sterilization or hysterectomy at least three months before the start of the study. 8) Has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. 9) Has abnormal findings at baseline, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study. 10) Has been previously been enrolled in this study. ;Exclusion criteria: 1) Has previously been treated with sunitinib 2) Has been treated with somatostatin analogues (long and short acting) during the last 6 months before inclusion. 3) Is likely to require any additional concomitant treatment with anti-proliferative effect to sunitinib and lanreotide Autogel 120mg for the pancreatic neuro-endocrine tumour. 4) Has been treated with radionuclide at any time prior to study entry 5) Has a history of drug hypersensitivity with a similar chemical structure to lanreotide Autogel 120mg and/or sunitinib. 6) Is likely to require treatment during the study with drugs that are not permitted by the study protocol. 7) Is at risk of pregnancy or lactation. Females of childbearing potential must provide a negative pregnancy test at the start of study and must be using oral, double barrier or injectable contraception. Non childbearing potential is defined as post-menopausal for at least 1 year, surgical sterilization or hysterectomy at least three months before the start of the study. 8) Has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. 9) Has abnormal findings at baseline, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study. 10) Has been previously been enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate a possible correlation between 18-FDG-PET-scan changes 4 weeks after treatment initiation with lanreotide plus sunitinib and time to tumour progression ;Secondary Objective: • To assess the safety of the combination therapy • To assess the efficacy of the combination therapy of sunitinib and lanreotide autogel 120 mg expressed as median time to tumour progression ;Primary end point(s): Patients will be clustered in groups according to their 18 FDG status at entry For the patients presenting a pos PET scan at entry, they will be clustered in groups according to the change in metabolism. Changes in metabolism will be expressed as : percentage decrease in SUV max at 4 weeks compared to SUV max at baseline: Group 1 :0% to 30 % decrease in tumour metabolism Group 2 : > 30 % decrease in tumour metabolism. Value of early response of (baseline compared with scan 4 weeks post treatment initiation of for negative scan at entry) PET scan using FDG on long term effect will be determined by correlating images to TTP : This is the percentage of patients in Group 2 presenting progressive disease at months 3,6,9 & 12 versus percentage of patients in Group 1 presenting progressive disease at months 3,6,9 & 12 Tumour assessments will be performed by means of CT-scans or magnetic resonance imaging (MRI) at study entry, every 12 weeks and to confirm progression. Patients will be followed up to a minimum of 12 months or until progression whatever comes first. Patients will be followed until the last patient included in the study will have progression or a 12 months follow up visit whatever comes first. Only the CT-scan or MRI taken at study entry and at progression (not the confirmation of progression) will be used to document time to tumour progression. Modified Recist 1.1 criteria will be used to determine tumour response ;Timepoint(s) of evaluation of this end point: at months 3,6,9 & 12;Main Objective: To investigate a possible correl | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tumour assessments will be performed by means of CT-scans or magnetic resonance imaging (MRI) at study entry, every 12 weeks and to confirm progression. Patients will be followed up to a minimum of 12 months or until progression whatever comes first. Patients will be followed until the last patient included in the study will have progression or a 12 months follow up visit whatever comes first. Only the CT-scan or MRI taken at study entry and at progression (not the confirmation of progression) will be used to document time to tumour progression. Modified Recist 1.1 criteria will be used to determine tumour response ;Timepoint(s) of evaluation of this end point: every 12 weeks untill tumour progression;Secondary end point(s): Tumour assessments will be performed by means of CT-scans or magnetic resonance imaging (MRI) at study entry, every 12 weeks and to confirm progression. Patients will be followed up to a minimum of 12 months or until progression whatever comes first. Patients will be followed until the last patient included in the study will have progression or a 12 months follow up visit whatever comes first. Only the CT-scan or MRI taken at study entry and at progression (not the confirmation of progression) will be used to document time to tumour progression. Modified Recist 1.1 criteria will be used to determine tumour response ;Timepoint(s) of evaluation of this end point: every 12 weeks untill tumour progression;Secondary end point(s): Tumour assessments will be performed by means of CT-scans or magnetic resonance imaging (MRI) at study entry, every 12 weeks and to confirm progression. Patients will be followed up to a minimum of 12 months or until progression whatever comes first. Patients will be followed until the last patient included in the study will have progression or a 12 months follow up visit whatever comes first. Only the CT-scan or MRI taken at study entry and at progression (not the confirmation of | — |
Countries
Belgium
Contacts
Public ContactThierry Delaunoit;Thierry Delaunoit;Thierry Delaunoit ;;
Hôpital de Jolimont;Hôpital de Jolimont;Hôpital de Jolimont
Outcome results
None listed