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Determine wether 24 months treatment with everolimus prolongs progression free survival rate (based on a central assessment) after embolisation ou chemoembolisation for liver metastases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| embolization or chemoembolization plus everolimus | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | 10 mg per day of everolimus during 24 months or until progression disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Hepatic Progression Free Survival at 24 Months | 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. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (Hepatic or Not) | 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 | From randomization until the date of first progression (clinical or radiological) or death from any cause whichever came first, assessed up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas WALTER, PhD | Hôpital Edouard Herriot - Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU - Hôtel Dieu | Angers | France | ||||
| Hôpital Avicenne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31678771 | Result | Walter T, Lepage C, Coriat R, Barbier E, Cadiot G, Caroli-Bosc FX, Aparicio T, Bouhier-Leporrier K, Hentic-Dhome O, Gay F, Dupont-Gossart AC, Duluc M, Lepere C, Lecomte T, Smith D, Petorin C, Di-Fiore F, Ghiringhelli F, Legoux JL, Guimbaud R, Baudin E, Lombard-Bohas C, de Baere T; FFCD 1104 investigators/investigators. Everolimus after hepatic arterial embolisation therapy of metastases from gastrointestinal neuroendocrine tumours: The FFCD 1104-EVACEL-GTE phase II study. Eur J Cancer. 2019 Dec;123:92-100. doi: 10.1016/j.ejca.2019.09.021. Epub 2019 Oct 31. |
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Before enrollement, standard examinations (biological, clinical) were done. In terms of imaging, abdominal and thoracic computed tomography scan or MRI were also done.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 18, 2015 | Aug 10, 2022 |
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| embolization | Device | 2 sessions embolization with spheric particles |
|
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| Doxorubicin | Drug | 2 sessions chemoembolization with 10 mg of lipiodol with 100 mg of doxorubicine |
|
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| Overall Survival | Overall 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. | From randomization until death or last news for alive patients |
| Bobigny |
| France |
| Hôpital Saint André | Bordeaux | France |
| Hôpital Côte de Nacre | Caen | France |
| CHU - Estaing | Clermont-Ferrand | France |
| Hôpital Beaujon | Clichy | France |
| Centre GF Leclerc | Dijon | France |
| CHU - Hôpital François Mitterand | Dijon | France |
| Hôpital Edouard Herriot | Lyon | France |
| CHU La Timone | Marseille | France |
| CHR | Orléans | France |
| CHU Cochin | Paris | France |
| Hôpital Européen Georges Pompidou | Paris | France |
| Hôpital Robert Debré | Reims | France |
| CHU | Rouen | France |
| Hôpital Rangueil | Toulouse | France |
| Hôpital Trousseau | Tours | France |
| Institut Gustave Roussy | Villejuif | France |
| COMPLETED |
|
| NOT COMPLETED |
|
All the patients enrolled in the study
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Hepatic Progression Free Survival at 24 Months | 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. | 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. | Posted | Count of Participants | Participants | Up to 24 months |
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| ||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (Hepatic or Not) | 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 | All patients included in the study | Posted | Median | 95% Confidence Interval | months | From randomization until the date of first progression (clinical or radiological) or death from any cause whichever came first, assessed up to 3 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall 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. | Posted | Median | 95% Confidence Interval | Months | From randomization until death or last news for alive patients |
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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)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 32 | 74 | 35 | 74 | 67 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Cardiac Failure | Cardiac disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | NCI CTC version 4.0 | Systematic Assessment |
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| General physical health deterioration | General disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Hyperthermia | General disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | NCI CTC version 4.0 | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | NCI CTC version 4.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Fever | General disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Infections | Infections and infestations | NCI CTC version 4.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Peripheral Oedema | General disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Deep Thrombosis | Vascular disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | NCI CTC version 4.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Dysguesia | Gastrointestinal disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Mucositis/stomatitis | Gastrointestinal disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Weight loss | Gastrointestinal disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Anorexia | Gastrointestinal disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Nail disorders | Skin and subcutaneous tissue disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | NCI CTC version 4.0 | Systematic Assessment |
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| Biological liver toxicity | Investigations | NCI CTC version 4.0 | Systematic Assessment |
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| Hypercholesterolemia | Investigations | NCI CTC version 4.0 | Systematic Assessment |
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| Hypertriglyceridemia | Investigations | NCI CTC version 4.0 | Systematic Assessment |
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| Hyperglycaemia | Investigations | NCI CTC version 4.0 | Systematic Assessment |
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| Hypoalbuminumia | Investigations | NCI CTC version 4.0 | Systematic Assessment |
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| Hypocalcemia | Investigations | NCI CTC version 4.0 | Systematic Assessment |
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| Hypokalaemia | Investigations | NCI CTC version 4.0 | Systematic Assessment |
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| Hyponatraemia | Investigations | NCI CTC version 4.0 | Systematic Assessment |
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| Hypomagnesaemia | Investigations | NCI CTC version 4.0 | Systematic Assessment |
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| Hypophosphataemia | Investigations | NCI CTC version 4.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karine Le Malicot | Fédération Francophone de Cancérologie Digestive | +33 3 80 39 34 79 | karine.le-malicot@u-bourgogne.fr |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 19, 2018 | Aug 10, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D004621 | Embolization, Therapeutic |
| D004317 | Doxorubicin |
| D016461 | Chemoembolization, Therapeutic |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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