Know Cancer

forgot password

Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer, KRAS Wildtype, After Resection of Liver Metastases

Thank you

Trial Information

Inclusion Criteria:

- Patient has provided written informed consent.

- R0-resection of liver metastasis, at least four weeks but not longer than 8 weeks

- Histologically confirmed diagnosis of metastatic colorectal cancer confined to the

- KRAS-wildtype of the tumor

- Age 18 years or older

- ECOG performance status 0-1

- Females with child-bearing potential must use adequate contraceptive measures

- Exclusion of pregnancy

- Relevant toxicities of previous treatments must have subsided

- Magnesium >= lower limit of normal; Calcium >= lower limit of normal

- Normal cardiac function demonstrated by ECG and echocardiogram (LVEF ≥ 55%)

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- Adequate organ function as defined by Table 1:

- Hematologic: ANC (absolute neutrophil count) >= 1.5 G/L, Leucocytes > 3.0 G/L,
Hemoglobin >= 9 g/dL, Platelets >= 100 G/L

- Hepatic: Albumin >= 2.5 g/dL, Serum bilirubin <= 2 mg/dL, AST and ALT <= 3 x ULN

- Renal: Serum Creatinine <= 1.5 mg/dL

Exclusion Criteria:

- Known manifestations of metastatic disease

- Progression during preoperative treatment

- Missing KRAS mutation status of the tumor

- Contraindication against therapy with 5-fluorouracil/ folinic acid or oxaliplatin

- Known intolerability of panitumumab

- Known DPD deficiency

- Polyneuropathy > grade 1 (NCI-CTCv4) which precludes the use of oxaliplatin

- Evidence of ascites or cirrhosis

- Patient is pregnant or lactating or planning to become pregnant within 6 months after
end of treatment

- Subject (male or female) is not willing to use highly effective methods of
contraception (per institutional standard) during treatment and for 6 months (male or
female) after the end of treatment

- Has had a major surgical procedure, open biopsy, or significant traumatic injury
within 28 days prior to study enrolment, or there is an anticipated need for major
surgical procedure during the course of the study

- Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
arrhythmia) <= 1 year before enrolment/randomization

- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or
evidence of interstitial lung disease on baseline chest CT scan

- Has a concurrent disease or condition that would make the subject inappropriate for
study participation or would interfere with the subject's safety.

- Has any psychological, familial, sociological, or geographical conditions that do not
permit compliance with the protocol.

- Requires concurrent cancer therapy (chemotherapy, radiation therapy, biologic
therapy, immunotherapy, or hormonal therapy) while on study.

- Requires concurrent treatment with an investigational agent, participation in another
clinical trial, or any specifically prohibited medication while on study.

- Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to 5-fluorouracil, folinic acid, oxaliplatin, or panitumumab.

- Other active malignancy

- Known alcohol abuse or drug addiction

- Incapability to give informed consent

Type of Study:


Study Design:

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

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

2 years after randomisation

Safety Issue:



Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

August 2011

Completion Date:

August 2014

Related Keywords:

  • Colorectal Cancer
  • KRAS Wildtype
  • After Resection of Liver Metastases
  • Colorectal Cancer
  • KRAS Wildtype
  • Liver metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms