- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01836653
Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases (ATOM)
Randomized Phase II Study of mFOLFOX6 + Bevacizumab or mFOLFOX6 + Cetuximab in Liver Only Metastasis From KRAS Wild Type Colorectal Cancer
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Tokyo
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Shinjuku-ku, Tokyo, Japon, 162-0814
- EPS Corporation
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Histopathologically confirmed colorectal cancer (adenocarcinoma) excluding vermiform appendix cancer and proctos cancer.
- RAS wild type
Synchronous* or metachronous liver limited meitastasis with no extrahepatic desiease
- shychronous liver limited metastasis with primary lesion less than two thirds of the circumference
- patients with primary lesion more than two thirds of the circumference can be enrolled after primary resection
- Patients who has one or more lesion(s) of diameter 1 cm or larger (RECEST v1.1) be able to assess continuously on the basis of the protocol by contrast enhanced CT or contrast enhanced MRI of the liver:
(1)Liver metastases 5 or more (2)Liver metastases with 5 cm or larger in greatest dimension (3)Unresectable considering remaining hepatic function (4)Invasion into all hepatic veins or inferior vena cava (5)Invasion into both right and left hepatic arteries or portal veins 5.No prior chemotherapy for colorectal cancer including hepatic arterial infusion. Excluding postoperative and preoperative chemoradiotherapy except for rectal cancer with synchronous liver metastases. Patients received postoperative chemotherapy containing oxaliplatin have to be enrolled after 24 weeks from the last oxaliplatin administration.
6.No previous treatment including ablation therapy, cryotherapy and chemotherapy for metastases 7.Age at enrollment is >=20 and =<80 years 8.The Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 9.Life expectancy from the day of enrollment is 3 months or longer 10.Major organ functions less than 14 days prior to entry meet the following criteria.
- Neu >= 1500/mm3
- Pt >= 10.0x10^4/mm3
- Hb >= 9.0 g/dL
- T-bil =< 2.0 mg/dL
- AST and ALT =< 200 IU/L
- sCr =< 1.20 mg/dL
- INR < 1.5
- Proteinuria =< 2+ 11.Written informed consent
Exclusion Criteria:
- Previously experienced severe allergic reaction to drugs
- Receiving anti-platelet drugs (aspirin >= 325 mg/day) or NSAIDs
- Receiving chronic systemic corticosteroid treatment
- Surgery/ biopsy with skin incision or traumatic injury with suture less than 14 days prior to entry. Excluding, suture for implanted venous reservoirs with catherter is allowed.
- Severe postoperative complications (e.g. postoperative infection, anastomic dehiscence or paralytic ileus)
- Diagnosed as hereditary colorectal cancer
- Active other malignancies
- Cerebrovascular disease or symptoms less than 1 year prior to entry
- Pleural effusion, ascites or cardiac effusion requiring drainage
- Hemorrhage/bleeding, paralytic ileus, obstruction or ulceration of gastrointestinal tract
- Perforation of gastrointestinal tract less than 1 year prior to entry
- Presence of active infection
- HBs antigen or HCV antibody positive
- Uncontrolled comorbidity including hypertension, diabetes, arrhythmia, or other diseases (such as cardiac disorder, interstitial pneumonia or renal disorder)
- Presence of >= grade 2 diarrhea
- Presence of >= grade 1 peripheral neuropathy
- Pregnant or lactating women. Women and men with childbearing potential unwilling to use effective means of contraception
- Psychosis or psychiatric symptoms who are not able to comply with the protocol
- Any other medical conditions disable to comply with the protocol
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: mFOLFOX + Bmab
mFOLFOX plus bevacizumab
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5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Autres noms:
85 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Autres noms:
200 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Autres noms:
400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Autres noms:
2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Autres noms:
|
Comparateur actif: mFOLFOX + Cmab
mFOLFOX plus cetuximab
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85 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Autres noms:
200 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Autres noms:
400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Autres noms:
2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Autres noms:
250 mg/m2 intravenously administered over 60 minutes (400 mg/m2 over 120 minutes as the initial dose) on day 1 and day 8 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Progression-free survival
Délai: assessed every 8 weeks, up to 4 years
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assessed by Independent Review Committee
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assessed every 8 weeks, up to 4 years
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Response rate
Délai: assessed every 8 weeks, up to 4 years
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assessed every 8 weeks, up to 4 years
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Tumor shrinkage rate at 8 week
Délai: assessed at 8 week, up to 8 weeks
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assessed at 8 week, up to 8 weeks
|
|
Liver resection rate
Délai: assessed every 8 weeks, up to 4 years
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assessed every 8 weeks, up to 4 years
|
|
R0 liver resection rate
Délai: assessed every 8 weeks, up to 4 years
|
pathologically confirmed R0 liver resection rate
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assessed every 8 weeks, up to 4 years
|
Progression-free survival
Délai: assessed every 8 weeks, up to 4 years
|
assessed by investigators
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assessed every 8 weeks, up to 4 years
|
Time to treatment-failure
Délai: assessed every 2 weeks, up to 4 years
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assessed every 2 weeks, up to 4 years
|
|
Overall survival
Délai: assessed every 2 weeks, up to 4 years
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assessed every 2 weeks, up to 4 years
|
|
Quality of life
Délai: assessed every 16 weeks, up to 1 year
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assessed every 16 weeks, up to 1 year
|
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Incidence of adverse events
Délai: assessed every 2 weeks, up to 4 years
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assessed every 2 weeks, up to 4 years
|
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Progression-free survival among the RAS wild type subpopulation
Délai: assessed every 8 weeks, up to 4 years
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All the assessment is repeated for a maximum of 4 years.
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assessed every 8 weeks, up to 4 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Yoshihiko Maehara, MD,PhD,FACS, Graduate School of Medical Science, Kyushu University, Department of Surgery and Science
- Chercheur principal: Naohiro Tomita, MD, PhD, Hyogo College of Medicine, Department of Surgery
- Chercheur principal: Ichinosuke Hyodo, MD, PhD, Tsukuba University, Graduate School of Medicine
- Chercheur principal: Michiaki Unno, MD, PhD, Tohoku University, Division of Gastroenterological Surgery
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Processus pathologiques
- Tumeurs
- Tumeurs par site
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies gastro-intestinales
- Maladies du côlon
- Maladies intestinales
- Tumeurs intestinales
- Maladies rectales
- Processus néoplasiques
- Tumeurs colorectales
- Métastase néoplasmique
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Antimétabolites, Antinéoplasique
- Antimétabolites
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Agents antinéoplasiques immunologiques
- Inhibiteurs de l'angiogenèse
- Agents modulateurs de l'angiogenèse
- Substances de croissance
- Inhibiteurs de croissance
- Fluorouracile
- Oxaliplatine
- Bévacizumab
- Cétuximab
Autres numéros d'identification d'étude
- ATOM (Autre identifiant: Radius Health, Inc.)
- UMIN000010209 (Autre identifiant: UMIN)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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