Trial Outcomes & Findings for Everolimus After (Chemo)Embolization for Liver Metastases From Digestive Endocrine Tumors (NCT NCT01678664)
NCT ID: NCT01678664
Last Updated: 2024-09-25
Results Overview
Hepatic progression free survival rate as defined in RECIST 1.1 (with death considered as progression) during the 24 months of treatment with everolimus. Progression-free survival rate (PFS) (based on the investigator) according to RECIST v1.1 according to RECIST v1.1 will be defined as the time from the date of inclusion to the date of hepatic progression or death (due to any cause). For patients who are alive with no hepatic progression, it will be defines as the time from the date of inclusion and the date of the last tumor assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2024-09-25
Participant Flow
Between 28th December 2012 and 16t March 2016, 74 patients were included by 19 french centers. Actual start date was actulaized in the protocol section.
Before enrollement, standard examinations (biological, clinical) were done. In terms of imaging, abdominal and thoracic computed tomography scan or MRI were also done.
Participant milestones
| Measure |
Embolization or Chemoembolization Plus Everolimus
After 2 sessions of embolization with microsphere of 100 to 500 µm or chemoembolization with 100 mg of doxorubicine and 10 ml of lipiodol, administered every day, 10 mg of everolimus during 24 months or until progression (hepatic and other site).
Everolimus: 10 mg per day of everolimus during 24 months or until progression disease
embolization: 2 sessions embolization with spheric particles
Doxorubicin: 2 sessions chemoembolization with 10 mg of lipiodol with 100 mg of doxorubicine
|
|---|---|
|
Overall Study
STARTED
|
74
|
|
Overall Study
COMPLETED
|
74
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Everolimus After (Chemo)Embolization for Liver Metastases From Digestive Endocrine Tumors
Baseline characteristics by cohort
| Measure |
Embolization or Chemoembolization Plus Everolimus
n=74 Participants
After 2 sessions of embolization with microsphere of 100 to 500 µm or chemoembolization with 100 mg of doxorubicine and 10 ml of lipiodol, administered every day, 10 mg of everolimus during 24 months or until progression (hepatic and other site).
Everolimus: 10 mg per day of everolimus during 24 months or until progression disease
embolization: 2 sessions embolization with spheric particles
Doxorubicin: 2 sessions chemoembolization with 10 mg of lipiodol with 100 mg of doxorubicine
|
|---|---|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
74 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
74 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: The analysis population for the primary endpoint was defined as the population of evaluable patients. A patient was considered evaluable if he or she hadreceived at least one dose of everolimus and at least one image on treatment. A patient who died (from any cause after treatment) or progressed to liver disease before 24 months was evaluable and considered a failure for the primary endpoint.
Hepatic progression free survival rate as defined in RECIST 1.1 (with death considered as progression) during the 24 months of treatment with everolimus. Progression-free survival rate (PFS) (based on the investigator) according to RECIST v1.1 according to RECIST v1.1 will be defined as the time from the date of inclusion to the date of hepatic progression or death (due to any cause). For patients who are alive with no hepatic progression, it will be defines as the time from the date of inclusion and the date of the last tumor assessment.
Outcome measures
| Measure |
Embolization or Chemoembolization Plus Everolimus
n=67 Participants
After 2 sessions of embolization with microsphere of 100 to 500 µm or chemoembolization with 100 mg of doxorubicine and 10 ml of lipiodol, administered every day, 10 mg of everolimus during 24 months or until progression (hepatic and other site).
Everolimus: 10 mg per day of everolimus during 24 months or until progression disease
embolization: 2 sessions embolization with spheric particles
Doxorubicin: 2 sessions chemoembolization with 10 mg of lipiodol with 100 mg of doxorubicine
|
|---|---|
|
Rate of Hepatic Progression Free Survival at 24 Months
Patients with hepatic progression or DCD at 24 months
|
47 Participants
|
|
Rate of Hepatic Progression Free Survival at 24 Months
Patients alive without hepatic progression at 24 months
|
20 Participants
|
SECONDARY outcome
Timeframe: From randomization until the date of first progression (clinical or radiological) or death from any cause whichever came first, assessed up to 3 yearsPopulation: All patients included in the study
Progression-free survival rate was defined as the time from the date of inclusion to the date of disease progression (hepatic or not) evaluated by RECIST V1.1 criteria or death (due to any cause) or the date of the last news for alive patients
Outcome measures
| Measure |
Embolization or Chemoembolization Plus Everolimus
n=74 Participants
After 2 sessions of embolization with microsphere of 100 to 500 µm or chemoembolization with 100 mg of doxorubicine and 10 ml of lipiodol, administered every day, 10 mg of everolimus during 24 months or until progression (hepatic and other site).
Everolimus: 10 mg per day of everolimus during 24 months or until progression disease
embolization: 2 sessions embolization with spheric particles
Doxorubicin: 2 sessions chemoembolization with 10 mg of lipiodol with 100 mg of doxorubicine
|
|---|---|
|
Progression-free Survival (Hepatic or Not)
|
16.9 months
Interval 12.6 to 22.4
|
SECONDARY outcome
Timeframe: From randomization until death or last news for alive patientsOverall survival was defined as the time from the date of inclusion to the date of death, regardless of the cause of death, or the date of last contact for patients who are alive.
Outcome measures
| Measure |
Embolization or Chemoembolization Plus Everolimus
n=74 Participants
After 2 sessions of embolization with microsphere of 100 to 500 µm or chemoembolization with 100 mg of doxorubicine and 10 ml of lipiodol, administered every day, 10 mg of everolimus during 24 months or until progression (hepatic and other site).
Everolimus: 10 mg per day of everolimus during 24 months or until progression disease
embolization: 2 sessions embolization with spheric particles
Doxorubicin: 2 sessions chemoembolization with 10 mg of lipiodol with 100 mg of doxorubicine
|
|---|---|
|
Overall Survival
|
51.0 Months
Interval 33.0 to 60.3
|
Adverse Events
Embolization or Chemoembolization Plus Everolimus
Serious events: 35 serious events
Other events: 67 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Embolization or Chemoembolization Plus Everolimus
n=74 participants at risk
After 2 sessions of embolization with microsphere of 100 to 500 µm or chemoembolization with 100 mg of doxorubicine and 10 ml of lipiodol, administered every day, 10 mg of everolimus during 24 months or until progression (hepatic and other site).
Everolimus: 10 mg per day of everolimus during 24 months or until progression disease
embolization: 2 sessions embolization with spheric particles
Doxorubicin: 2 sessions chemoembolization with 10 mg of lipiodol with 100 mg of doxorubicine
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.4%
4/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.7%
2/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Cardiac disorders
Cardiac Failure
|
4.1%
3/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
5/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Gastrointestinal disorders
Nausea
|
2.7%
2/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
3/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
General disorders
General physical health deterioration
|
8.1%
6/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
General disorders
Hyperthermia
|
2.7%
2/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Hepatobiliary disorders
Cholecystitis
|
6.8%
5/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.7%
2/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Infections and infestations
Sepsis
|
2.7%
2/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Metabolism and nutrition disorders
Malnutrition
|
4.1%
3/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
2/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
Other adverse events
| Measure |
Embolization or Chemoembolization Plus Everolimus
n=74 participants at risk
After 2 sessions of embolization with microsphere of 100 to 500 µm or chemoembolization with 100 mg of doxorubicine and 10 ml of lipiodol, administered every day, 10 mg of everolimus during 24 months or until progression (hepatic and other site).
Everolimus: 10 mg per day of everolimus during 24 months or until progression disease
embolization: 2 sessions embolization with spheric particles
Doxorubicin: 2 sessions chemoembolization with 10 mg of lipiodol with 100 mg of doxorubicine
|
|---|---|
|
General disorders
Fatigue
|
79.7%
59/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
General disorders
Fever
|
33.8%
25/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Infections and infestations
Infections
|
28.4%
21/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.8%
8/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
General disorders
Peripheral Oedema
|
35.1%
26/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Vascular disorders
Deep Thrombosis
|
5.4%
4/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
82.4%
61/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Blood and lymphatic system disorders
Leukopenia
|
51.4%
38/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.4%
21/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.8%
8/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
47.3%
35/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Gastrointestinal disorders
Dysguesia
|
10.8%
8/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
43.2%
32/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Gastrointestinal disorders
Weight loss
|
10.8%
8/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
63.5%
47/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
36.5%
27/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Gastrointestinal disorders
Anorexia
|
28.4%
21/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Gastrointestinal disorders
Nausea
|
33.8%
25/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Gastrointestinal disorders
Vomiting
|
29.7%
22/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
10.8%
8/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.8%
8/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.5%
10/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.5%
7/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Skin and subcutaneous tissue disorders
Nail disorders
|
5.4%
4/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.5%
7/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.9%
11/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.3%
15/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Investigations
Biological liver toxicity
|
86.5%
64/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Investigations
Hypercholesterolemia
|
50.0%
37/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Investigations
Hypertriglyceridemia
|
51.4%
38/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Investigations
Hyperglycaemia
|
68.9%
51/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Investigations
Hypoalbuminumia
|
14.9%
11/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Investigations
Hypocalcemia
|
35.1%
26/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Investigations
Hypokalaemia
|
14.9%
11/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Investigations
Hyponatraemia
|
31.1%
23/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Investigations
Hypomagnesaemia
|
18.9%
14/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
|
Investigations
Hypophosphataemia
|
29.7%
22/74 • Up to the end of treatment Death were monitored even the patient has stopped the study treatment (up to 5 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=24 months)
|
Additional Information
Karine Le Malicot
Fédération Francophone de Cancérologie Digestive
Phone: +33 3 80 39 34 79
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place