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| ID | Type | Description | Link |
|---|---|---|---|
| A5961076 |
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To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan + 5 FU + folinic acid | Drug | irinotecan 180 mg/m2 folinic acid 400 mg/m2 (DL) followed by 5 FU bolus 400 mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival (DFS) | time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer. | last tumor assessment date or cut-off date, whichever is earlier. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Rates | Probability of being alive was calculated in a yearly increment. | Median follow-up time (42 months) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Ghent | 9000 | Belgium | |||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Eligible subjects (subjects who underwent complete liver metastasis resection within 8 weeks of study drug administration) were randomly assigned. Of the 321 subjects randomized in the study, all but 15 were treated.
study was conducted at 66 centers.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 5-FU/FA | simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months) |
| FG001 | Irinotecan + 5-FU/FA | irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Folinic Acid + 5 FU | Drug | folinic acid 400 mg/m2(DL) followed by bolus 5 FU 400mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks |
|
| Roeselare |
| 8800 |
| Belgium |
| Pfizer Investigational Site | Copenhagen | 2100 | Denmark |
| Pfizer Investigational Site | Herlev | DK-2730 | Denmark |
| Pfizer Investigational Site | Odense | DK5000 | Denmark |
| Pfizer Investigational Site | Amiens | 80054 | France |
| Pfizer Investigational Site | Avignon | 84000 | France |
| Pfizer Investigational Site | Boulogne-Billancourt | France |
| Pfizer Investigational Site | Clermont-Ferand Cedex 1 | 63058 | France |
| Pfizer Investigational Site | Colmar | 68024 | France |
| Pfizer Investigational Site | Grenoble | 38043 | France |
| Pfizer Investigational Site | Marseille | 13005 | France |
| Pfizer Investigational Site | Marseille | 13273 CEDEX 09 | France |
| Pfizer Investigational Site | Marseille | 13273 | France |
| Pfizer Investigational Site | Montpellier | 34295 | France |
| Pfizer Investigational Site | Montpellier | 34298 CEDEX 5 | France |
| Pfizer Investigational Site | Nice | 06031 | France |
| Pfizer Investigational Site | Nîmes | 30900 | France |
| Pfizer Investigational Site | Rennes | 35042 | France |
| Pfizer Investigational Site | Strasbourg | 67091 | France |
| Pfizer Investigational Site | Toulouse | 31059 | France |
| Pfizer Investigational Site | Cottbus | 03048 | Germany |
| Pfizer Investigational Site | Dessau | 06847 | Germany |
| Pfizer Investigational Site | Erlangen | 91054 | Germany |
| Pfizer Investigational Site | Hamburg | 20246 | Germany |
| Pfizer Investigational Site | Leipzig | 04103 | Germany |
| Pfizer Investigational Site | Magdeburg | 39104 | Germany |
| Pfizer Investigational Site | Magdeburg | 39120 | Germany |
| Pfizer Investigational Site | Mainz | 55131 | Germany |
| Pfizer Investigational Site | Oldenburg | 26133 | Germany |
| Pfizer Investigational Site | Regensburg | 93042 | Germany |
| Pfizer Investigational Site | Tübingen | 72076 | Germany |
| Pfizer Investigational Site | Hong Kong | Hong Kong |
| Pfizer Investigational Site | Haifa | Israel |
| Pfizer Investigational Site | Petah Tikva | Israel |
| Pfizer Investigational Site | Rehovot | 76100 | Israel |
| Pfizer Investigational Site | Tel Aviv | 64239 | Israel |
| Pfizer Investigational Site | Tel Litwinsky | Israel |
| Pfizer Investigational Site | Carpi | Modena | 41012 | Italy |
| Pfizer Investigational Site | Brescia | 25123 | Italy |
| Pfizer Investigational Site | Latisana, UD | 33053 | Italy |
| Pfizer Investigational Site | Padova | 35100 | Italy |
| Pfizer Investigational Site | Parma | 43100 | Italy |
| Pfizer Investigational Site | Piacenza | 29100 | Italy |
| Pfizer Investigational Site | Reggio Emilia | 42100 | Italy |
| Pfizer Investigational Site | Rozzano (Mi) | 20089 | Italy |
| Pfizer Investigational Site | Porto | 4200 | Portugal |
| Pfizer Investigational Site | Panorama | Cape Town | 7500 | South Africa |
| Pfizer Investigational Site | Daegu | 700-721 | South Korea |
| Pfizer Investigational Site | Goyang | 411764 | South Korea |
| Pfizer Investigational Site | Seoul | 120-753 | South Korea |
| Pfizer Investigational Site | Seoul | 135-710 | South Korea |
| Pfizer Investigational Site | Seoul | 139-240 | South Korea |
| Pfizer Investigational Site | Barcelona | Barcelona | 08036 | Spain |
| Pfizer Investigational Site | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Pfizer Investigational Site | Santander | Cantabria | 39008 | Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28041 | Spain |
| Pfizer Investigational Site | Seville | Sevilla | 41014 | Spain |
| Pfizer Investigational Site | Gothenburg | 413 45 | Sweden |
| Pfizer Investigational Site | Bern | 3010 | Switzerland |
| Pfizer Investigational Site | Taoyuan | Taiwan |
| Pfizer Investigational Site | Donetsk | Ukraine | 83092 | Ukraine |
| Pfizer Investigational Site | Kiev | 03922 | Ukraine |
| Pfizer Investigational Site | London | N18 1QX | United Kingdom |
| Pfizer Investigational Site | Southampton | SO16 6YD | United Kingdom |
| Pfizer Investigational Site | Surrey | GU2 7XX | United Kingdom |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 5-FU/FA | simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months) |
| BG001 | Irinotecan + 5-FU/FA | irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Disease Free Survival (DFS) | time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer. | Full analysis set = all treated subjects according to randomization: n=153, 153 for 5-FU/FA & Irinotecan + 5-FU/FA, respectively. Safety analysis set (for Adverse Events) = all treated subjects according to treatment actually received (1 subject randomized to 5-FU/FA actually received treatment from Irinotecan + 5-FU/FA). n=152, 154 as above). | Posted | Median | 95% Confidence Interval | months | last tumor assessment date or cut-off date, whichever is earlier. |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Rates | Probability of being alive was calculated in a yearly increment. | Full analysis set = all treated subjects according to randomization: n=153, 153 for 5-FU/FA & Irinotecan + 5-FU/FA, respectively. Safety analysis set (for Adverse Events) = all treated subjects according to treatment actually received (1 subject randomized to 5-FU/FA actually received treatment from Irinotecan + 5-FU/FA). n=152, 154 as above). | Posted | Number | survival rate | Median follow-up time (42 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 | 5-FU/FA | simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months) | 15 | 152 | 146 | 152 | ||
| EG001 | Irinotecan + 5-FU/FA | irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months) | 32 | 154 | 150 | 154 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain NOS | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Anaemia NOS | Blood and lymphatic system disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Appendicitis | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Axillary vein thrombosis | Vascular disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Cardiac disorder NOS | Cardiac disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Catheter related complication | General disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA(v5.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Cholecystitis acute NOS | Hepatobiliary disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Device failure | Injury, poisoning and procedural complications | MedDRA(v5.1) | Systematic Assessment |
| |
| Diarrhoea NOS | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Gait abnormal | General disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Hepatic disorder NOS | Hepatobiliary disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Injection site thrombosis | General disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Intestinal obstruction NOS | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA(v5.1) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA(v5.1) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Peripheral swelling | Musculoskeletal and connective tissue disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Phlebitis NOS | Vascular disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Pneumothorax NOS | Respiratory, thoracic and mediastinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Rectovaginal fistula | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Renal impairment NOS | Renal and urinary disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA(v5.1) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA(v5.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Tachycardia NOS | Cardiac disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Abdominal pain, NOS | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Anemia NOS | Blood and lymphatic system disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Appetite decreased NOS | Metabolism and nutrition disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Cholinergic syndrome | Nervous system disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Diarrhea, NOS | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Dyspnoea NOS | Respiratory, thoracic and mediastinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Leukopenia NOS | Blood and lymphatic system disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Mucosal inflammation NOS | General disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Pigmentation disorder NOS | Skin and subcutaneous tissue disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Rhinitis NOS | Respiratory, thoracic and mediastinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA(v5.1) | Systematic Assessment |
| |
| Vomiting, NOS | Gastrointestinal disorders | MedDRA(v5.1) | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D008113 | Liver 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 |
| D008107 | Liver Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
Not provided
Not provided
| Male |
|
| 95 |
| No |
| Superiority or Other |
|