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Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases (ATOM)

1 août 2017 mis à jour par: EPS Corporation

Randomized Phase II Study of mFOLFOX6 + Bevacizumab or mFOLFOX6 + Cetuximab in Liver Only Metastasis From KRAS Wild Type Colorectal Cancer

The purpose of this study is to evaluate efficacy and safety of mFOLFOX6+bevacizumab and mFOLFOX6+cetuximab for liver only metastasis from KRAS Exon 2 wild type (under protocol 1.0-1.2 edition) and RAS wild type (under protocol 2.0 edition) colorectal cancer.

Aperçu de l'étude

Description détaillée

Description: The purpose of this study is to evaluate efficacy and safety of mFOLFOX6+bevacizumab and mFOLFOX6+cetuximab for liver only metastasis from KRAS Exon 2 wild type (under protocol 1.0-1.2 edition) and RAS wild type (under protocol 2.0 edition) colorectal cancer.

Type d'étude

Interventionnel

Inscription (Réel)

122

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Tokyo
      • Shinjuku-ku, Tokyo, Japon, 162-0814
        • EPS Corporation

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. Histopathologically confirmed colorectal cancer (adenocarcinoma) excluding vermiform appendix cancer and proctos cancer.
  2. RAS wild type
  3. 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
  4. 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.

  1. Neu >= 1500/mm3
  2. Pt >= 10.0x10^4/mm3
  3. Hb >= 9.0 g/dL
  4. T-bil =< 2.0 mg/dL
  5. AST and ALT =< 200 IU/L
  6. sCr =< 1.20 mg/dL
  7. INR < 1.5
  8. Proteinuria =< 2+ 11.Written informed consent

Exclusion Criteria:

  1. Previously experienced severe allergic reaction to drugs
  2. Receiving anti-platelet drugs (aspirin >= 325 mg/day) or NSAIDs
  3. Receiving chronic systemic corticosteroid treatment
  4. 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.
  5. Severe postoperative complications (e.g. postoperative infection, anastomic dehiscence or paralytic ileus)
  6. Diagnosed as hereditary colorectal cancer
  7. Active other malignancies
  8. Cerebrovascular disease or symptoms less than 1 year prior to entry
  9. Pleural effusion, ascites or cardiac effusion requiring drainage
  10. Hemorrhage/bleeding, paralytic ileus, obstruction or ulceration of gastrointestinal tract
  11. Perforation of gastrointestinal tract less than 1 year prior to entry
  12. Presence of active infection
  13. HBs antigen or HCV antibody positive
  14. Uncontrolled comorbidity including hypertension, diabetes, arrhythmia, or other diseases (such as cardiac disorder, interstitial pneumonia or renal disorder)
  15. Presence of >= grade 2 diarrhea
  16. Presence of >= grade 1 peripheral neuropathy
  17. Pregnant or lactating women. Women and men with childbearing potential unwilling to use effective means of contraception
  18. Psychosis or psychiatric symptoms who are not able to comply with the protocol
  19. Any other medical conditions disable to comply with the protocol

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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
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:
  • Avastin
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:
  • Oxaliplatine
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:
  • Lévofolinate
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:
  • Fluorouracile
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:
  • Fluorouracile
Comparateur actif: mFOLFOX + Cmab
mFOLFOX plus cetuximab
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:
  • Oxaliplatine
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:
  • Lévofolinate
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:
  • Fluorouracile
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:
  • Fluorouracile
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:
  • Erbitux

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
assessed by Independent Review Committee
assessed every 8 weeks, up to 4 years

Mesures de résultats secondaires

Mesure des résultats
Délai
Response rate
Délai: assessed every 8 weeks, up to 4 years
assessed every 8 weeks, up to 4 years

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
assessed at 8 week, up to 8 weeks
Liver resection rate
Délai: assessed every 8 weeks, up to 4 years
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
assessed every 8 weeks, up to 4 years
Progression-free survival
Délai: assessed every 8 weeks, up to 4 years
assessed by investigators
assessed every 8 weeks, up to 4 years
Time to treatment-failure
Délai: assessed every 2 weeks, up to 4 years
assessed every 2 weeks, up to 4 years
Overall survival
Délai: assessed every 2 weeks, up to 4 years
assessed every 2 weeks, up to 4 years
Quality of life
Délai: assessed every 16 weeks, up to 1 year
assessed every 16 weeks, up to 1 year
Incidence of adverse events
Délai: assessed every 2 weeks, up to 4 years
assessed every 2 weeks, up to 4 years
Progression-free survival among the RAS wild type subpopulation
Délai: assessed every 8 weeks, up to 4 years
All the assessment is repeated for a maximum of 4 years.
assessed every 8 weeks, up to 4 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

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

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mai 2013

Achèvement primaire (Réel)

1 mars 2017

Achèvement de l'étude (Réel)

1 mars 2017

Dates d'inscription aux études

Première soumission

14 avril 2013

Première soumission répondant aux critères de contrôle qualité

19 avril 2013

Première publication (Estimation)

22 avril 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 août 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 août 2017

Dernière vérification

1 août 2017

Plus d'information

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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