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

Phase 2
20 Years
80 Years
Open (Enrolling)
Liver Only Metastasis From KRAS Wild Type Colorectal Cancer

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Trial Information

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

Description: The purpose of this study is to evaluate efficacy and safety of
mFOLFOX6+bevacizumab and mFOLFOX6+cetuximab for KRAS wild type colorectal cancer patients
with liver limited metastasis.

Inclusion Criteria:

1. Histopathologically confirmed colorectal cancer (adenocarcinoma) excluding vermiform
appendix cancer and proctos cancer.

2. EGFR positive

3. KRAS wild type

4. Synchronous* or metachronous liver limited metastasis with no extrahepatic disease

- 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

5. 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 6.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

7.No previous treatment including ablation therapy, cryotherapy and chemotherapy for
metastases 8.Age at enrollment is >=20 and =<80 years 9.The Eastern Cooperative Oncology
Group (ECOG) Performance Status 0-1 10.Life expectancy from the day of enrollment is 3
months or longer 11.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+ 12.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 28 days
prior to entry. Excluding, suture for implanted venous reservoirs with catherter is

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

Centrally reviewed progression-free survival assessed by CT image

Outcome Time Frame:

assessed every 8 weeks

Safety Issue:


Principal Investigator

Yoshihiko Maehara, MD,PhD,FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Graduate School of Medical Science, Kyushu University, Department of Surgery and Science


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

May 2013

Completion Date:

Related Keywords:

  • Liver Only Metastasis From KRAS Wild Type Colorectal Cancer
  • Bevacizumab
  • Cetuximab
  • KRAS wild type colorectal cancer
  • liver metastasis
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary