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| Name | Class |
|---|---|
| Biocompatibles UK Ltd | INDUSTRY |
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Treatment of patients with colorectal cancer having liver metastases is currently based on systemic chemotherapy.
Triple therapy with 5FU, oxaliplatin and irinotecan intravenously was effective in terms of response and secondary resectability, however it is particularly toxic.
Hepatic intra-arterial chemotherapy (HIA) has been the subject of several studies. It has shown good efficacy with oxaliplatin and FUDR. However, the procedure is difficult to set up and reserved for experienced centers.
The objective of this protocol is to use a triple therapy based on 5FU and oxaliplatin associated to irinotecan which is administered by hepatic intra-arterial route, loaded onto microbeads (DEBIRI). Furthermore, the procedure for chemo-embolization DEBIRI is limited to 2 sessions, and therefore could be more easily generalized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIA DEBIRI + systemic FOLFOX | Experimental | Intra-arterial hepatic beads loaded with irinotecan with systemic FOLFOX |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIA DEBIRI + systemic FOLFOX | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival Rate at 9 Months | The primary endpoint was to evaluate the rate of patients alive without progression at 9 months after the start of treatment. Events to be considered for the endpoint were:
| at 9 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | It was defined as the time interval between the date of inclusion and the date of death (whatever the cause). Patients lost to follow-up or alive at the time of analysis were censored at the date of last news. | up to 4 years after patient's inclusion |
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Inclusion Criteria:
Exclusion Criteria:
Presence of biliary-digestive anastomosis or biliary stent Cruoric or tumor thrombosis of the portal vein
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| Name | Affiliation | Role |
|---|---|---|
| Julien TAIEB, Pr | Fédération Francophone de Cancérologie Digestive | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Saint André | Bordeaux | 33075 | France | |||
| CHU - Hôpital François Mitterand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32507854 | Result | Pernot S, Pellerin O, Artru P, Monterymard C, Smith D, Raoul JL, De La Fouchardiere C, Dahan L, Guimbaud R, Sefrioui D, Jouve JL, Lepage C, Tougeron D, Taieb J; for FFCD1201-DEBIRI investigators/Collaborators. Intra-arterial hepatic beads loaded with irinotecan (DEBIRI) with mFOLFOX6 in unresectable liver metastases from colorectal cancer: a Phase 2 study. Br J Cancer. 2020 Aug;123(4):518-524. doi: 10.1038/s41416-020-0917-4. Epub 2020 Jun 8. |
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Fifty eight patients were included in the study between May 2013 and December 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | HIA DEBIRI + Systemic FOLFOX | Patients received induction chemotherapy with FOLFOX: oxaliplatin 85 mg/m2 as a 2-h infusion at day 1, leucovorin 400 mg/m2 as a 120-min infusion at day 1 followed by 5FU 400 mg/m2 bolus at day 1 and 2400 mg/m2 46-h continuous 5FU infusion, 1 cycle every 2 weeks. Patients received treatment with DC Bead LUMI™ 100-300 loaded with irinotecan 50 mg/ml, 1 vial per lobe and per treatment (meaning 1 vial in case of unilobar administration, and 2 vials in case of bilobar administration). Each treatment session was performed 48-72 h after a chemotherapy cycle. Treatment administration was performed using a unilateral femoral approach. |
| 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 | Jul 28, 2015 | Aug 19, 2022 |
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| Dijon |
| France |
| Hôpital Prive Jean Mermoz | Lyon | 69008 | France |
| Centre Léon Berard | Lyon | 69373 | France |
| Institut Paoli Calmette | Marseille | 13273 | France |
| CHU de la TIMONE | Marseille | 13385 | France |
| Hôpital Europeen G Pompidou | Paris | 75015 | France |
| CHU Charles Nicolle | Rouen | 76031 | France |
| Hôpital Rangueil | Toulouse | 31059 | France |
| COMPLETED |
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| NOT COMPLETED |
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Baseline population is on ITT population meaning all patients included excepted the patient wrongly included (beacuase of pancreatic metastases and not colorectal metastases)
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| ID | Title | Description |
|---|---|---|
| BG000 | HIA DEBIRI + Systemic FOLFOX | Intra-arterial hepatic beads loaded with irinotecan with systemic FOLFOX HIA DEBIRI + systemic FOLFOX |
| 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 and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Progression-free Survival Rate at 9 Months | The primary endpoint was to evaluate the rate of patients alive without progression at 9 months after the start of treatment. Events to be considered for the endpoint were:
| Primary endpoint was on mITT population meaning all the patients included in the study with at least one radiological assessments within the 9 months following the inclusion | Posted | Count of Participants | Participants | at 9 months after inclusion |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival | It was defined as the time interval between the date of inclusion and the date of death (whatever the cause). Patients lost to follow-up or alive at the time of analysis were censored at the date of last news. | Endpoint was analyzed on the ITT population | Posted | Median | 95% Confidence Interval | months | up to 4 years after patient's inclusion |
|
|
Up to the end of treatment for each patient, up to 3 years After the end of the treatment, patients were followed-up only for the overall survival up to 4 years.
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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 | HIA DEBIRI + Systemic FOLFOX | Intra-arterial hepatic beads loaded with irinotecan with systemic FOLFOX HIA DEBIRI + systemic FOLFOX | 31 | 57 | 27 | 57 | 57 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Gastrointestinal toxicity | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Pancreatitis acute | 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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| Asthenia | General disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Chest pain | General 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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| Injection site extravasation | General disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Malaise | General disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Pyrexia | General disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | NCI-CTC version 4.0 | Systematic Assessment |
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| Escherichia bacteraemia | Infections and infestations | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | 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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| Superinfection bacterial | Infections and infestations | NCI-CTC version 4.0 | Systematic Assessment |
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| Superinfection | Infections and infestations | NCI-CTC version 4.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | NCI-CTC version 4.0 | Systematic Assessment |
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| Deshydratation | Metabolism and nutrition disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Tumor obstruction | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | NCI-CTC version 4.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Allergic reaction | Immune system disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Cephalgia | Nervous system disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Neuropathy | Nervous system disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Constipation | 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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| Mucositis | 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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| Pancreatitis | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system 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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| Hepatalgia | Hepatobiliary disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue 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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| Thromboembolic event | Vascular disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Urinary tractus infection | Infections and infestations | NCI-CTC version 4.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | NCI-CTC version 4.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | NCI-CTC version 4.0 | Systematic Assessment |
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| Total Bilirubin increased | Investigations | NCI-CTC version 4.0 | Systematic Assessment |
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| Creatinine increased | Investigations | NCI-CTC version 4.0 | Systematic Assessment |
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| Gammaglutamyltransferase increased | Investigations | NCI-CTC version 4.0 | Systematic Assessment |
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| White blood cell count decreased | Investigations | NCI-CTC version 4.0 | Systematic Assessment |
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| Lymphocytes decreased | Investigations | NCI-CTC version 4.0 | Systematic Assessment |
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| Phosphatases alcalines increased | Investigations | NCI-CTC version 4.0 | Systematic Assessment |
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| Weight loss | Investigations | NCI-CTC version 4.0 | Systematic Assessment |
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| Platelets decreased | Investigations | NCI-CTC version 4.0 | Systematic Assessment |
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| Neutropenia | Investigations | NCI-CTC version 4.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Hyperkaliemia | Metabolism and nutrition disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Hypokaliemia | Metabolism and nutrition disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | NCI-CTC version 4.0 | Systematic Assessment |
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| 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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| 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 | Feb 9, 2017 | Aug 19, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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