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 Clinical Trial
— ATOMOfficial title:
Randomized Phase II Study of mFOLFOX6 + Bevacizumab or mFOLFOX6 + Cetuximab in Liver Only Metastasis From KRAS Wild Type Colorectal Cancer
| Verified date | August 2017 |
| Source | EPS Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 122 |
| Est. completion date | March 2017 |
| Est. primary completion date | March 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | EPS Corporation | Shinjuku-ku | Tokyo |
| Lead Sponsor | Collaborator |
|---|---|
| EPS Corporation |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Tumor shrinkage rate at 8 week | assessed at 8 week, up to 8 weeks | ||
| Other | Liver resection rate | assessed every 8 weeks, up to 4 years | ||
| Other | R0 liver resection rate | pathologically confirmed R0 liver resection rate | assessed every 8 weeks, up to 4 years | |
| Other | Progression-free survival | assessed by investigators | assessed every 8 weeks, up to 4 years | |
| Other | Time to treatment-failure | assessed every 2 weeks, up to 4 years | ||
| Other | Overall survival | assessed every 2 weeks, up to 4 years | ||
| Other | Quality of life | assessed every 16 weeks, up to 1 year | ||
| Other | Incidence of adverse events | assessed every 2 weeks, up to 4 years | ||
| Other | Progression-free survival among the RAS wild type subpopulation | All the assessment is repeated for a maximum of 4 years. | assessed every 8 weeks, up to 4 years | |
| Primary | Progression-free survival | assessed by Independent Review Committee | assessed every 8 weeks, up to 4 years | |
| Secondary | Response rate | assessed every 8 weeks, up to 4 years |