- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Tokyo
-
Shinjuku-ku, Tokyo, Japan, 162-0814
- EPS Corporation
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
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.
Andra namn:
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.
Andra namn:
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.
Andra namn:
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.
Andra namn:
|
|
Aktiv komparator: 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.
Andra namn:
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.
Andra namn:
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.
Andra namn:
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.
Andra namn:
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression-free survival
Tidsram: assessed every 8 weeks, up to 4 years
|
assessed by Independent Review Committee
|
assessed every 8 weeks, up to 4 years
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Response rate
Tidsram: assessed every 8 weeks, up to 4 years
|
assessed every 8 weeks, up to 4 years
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Tumor shrinkage rate at 8 week
Tidsram: assessed at 8 week, up to 8 weeks
|
assessed at 8 week, up to 8 weeks
|
|
|
Liver resection rate
Tidsram: assessed every 8 weeks, up to 4 years
|
assessed every 8 weeks, up to 4 years
|
|
|
R0 liver resection rate
Tidsram: 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
Tidsram: assessed every 8 weeks, up to 4 years
|
assessed by investigators
|
assessed every 8 weeks, up to 4 years
|
|
Time to treatment-failure
Tidsram: assessed every 2 weeks, up to 4 years
|
assessed every 2 weeks, up to 4 years
|
|
|
Overall survival
Tidsram: assessed every 2 weeks, up to 4 years
|
assessed every 2 weeks, up to 4 years
|
|
|
Quality of life
Tidsram: assessed every 16 weeks, up to 1 year
|
assessed every 16 weeks, up to 1 year
|
|
|
Incidence of adverse events
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Yoshihiko Maehara, MD,PhD,FACS, Graduate School of Medical Science, Kyushu University, Department of Surgery and Science
- Huvudutredare: Naohiro Tomita, MD, PhD, Hyogo College of Medicine, Department of Surgery
- Huvudutredare: Ichinosuke Hyodo, MD, PhD, Tsukuba University, Graduate School of Medicine
- Huvudutredare: Michiaki Unno, MD, PhD, Tohoku University, Division of Gastroenterological Surgery
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Patologiska processer
- Neoplasmer
- Neoplasmer efter plats
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Kolonsjukdomar
- Tarmsjukdomar
- Intestinala neoplasmer
- Rektala sjukdomar
- Neoplastiska processer
- Kolorektala neoplasmer
- Neoplasma Metastas
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antineoplastiska medel, immunologiska
- Angiogeneshämmare
- Angiogenesmodulerande medel
- Tillväxtämnen
- Tillväxthämmare
- Fluorouracil
- Oxaliplatin
- Bevacizumab
- Cetuximab
Andra studie-ID-nummer
- ATOM (Radius Health, Inc.)
- UMIN000010209 (Annan identifierare: UMIN)
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