Treatment Regimens for Patients With Resectable Liver Metastases (PANTER Study)

NCT01266187 | Terminated

• 1 other identifier: CTC-A10-005
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Is a perioperative chemotherapy based on FOLFOX and Cetuximab (K-RAS wild-type) associated with a higher rate of postoperative complications in patients with resectable colorectal liver metastases as compared to only adjuvant FOLFOX and chemotherapy? Are there any differences for disease free survival between periand postoperative treatment in patients with \>3 liver metastases or at least one metastasis \> or = 5 cm in diameter?

Conditions

Liver Metastasis

Keywords

FOLFOX; liver metastasis; cetuximab

Outcome Measures

Primary Outcomes (2)

• Clavien score (> grade 1)

  The first primary objective of the study is to compare the postoperative complication rate according to Clavien score (\> grade 1) of a perioperative chemotherapy with a postoperative regimen

  1 year

• Disease free survival

  A second primary objective of the study is to compare for the patient subgroup with \>3 liver metastases or at least one metastasis \> or = 5 cm in diameter the median disease free survival.

  1 year

Secondary Outcomes (1)

• Secondary objectives

  5 years

Study Arms (2)

Arm B

EXPERIMENTAL

12 weeks FOLFOX + cetuximab -\> 4 weeks rest -\> surgery -\> 4-8 weeks rest -\> 12 weeks FOLFOX + cetuximab

Procedure: perioperative/Folfox + cetuximab

Arm A

ACTIVE COMPARATOR

surgery -\> 4-8 weeks rest -\> 24 weeks FOLFOX + cetuximab

Procedure: adjuvant surgery + FOLFOX + cetuximab

Interventions

adjuvant surgery + FOLFOX + cetuximab PROCEDURE

surgery -\> 4-8 weeks rest -\> 24 weeks FOLFOX + cetuximab

Arm A

perioperative/Folfox + cetuximab PROCEDURE

12 weeks FOLFOX + cetuximab -\> 4 weeks rest -\> surgery -\> 4-8 weeks rest -\> 12 weeks FOLFOX + cetuximab

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent obtained prior to any study-specific procedure.
• Age \> 18 years
• Proven K-RAS wildtype in primary tumour or metastasis tissue
• Diagnosis of resectable metachronous metastases after complete resection (R0) of primary tumour without gross or microscopic evidence of residual disease. or Diagnosis of resectable synchronous metastases after complete resection (R0) of primary tumour more than 1 month before study or Diagnosis of resectable synchronous metastases with sufficient evidence (i.e., CT scan or diagnostic laparoscopy) that both the primary tumour and liver metastases can be completely resected during the same procedure and resection of primary can be delayed 3-4 months.
• Negative pregnancy test
• Highly effective contraception during treatment and for at least 3 months thereafter in women (defined as pearl index \< 1) and men, if the risk of conception exists
• Planned start of study medication between 0 and 3 weeks post randomization
• ECOG performance status 0 or 1 (Appendix 1)
• Adequate hematology: neutrophils \> 1,5 /nl, platelets \> 100/nl, INR \< 1,5, aPTT \< 1,5 x UNL
• Adequate biochemistry: total bilirubin \< 1,5 x UNL, ASAT and ALAT \< 5 x UNL, alkaline phosphatase \< 5 x UNL, serum creatinine \< 1,5, x UNL.

You may not qualify if:

• Patients with any relationship of dependence to the sponsor or the investigator
• Patients committed to an institution (court-ordered or by official orders)
• Extrahepatic metastatic disease
• Proven K-RAS mutation or unknown K-RAS mutational status in tumour tissue
• Oxaliplatin-based adjuvant chemotherapy within 1 year before randomization
• Neuropathy \> or = grade 3 (NCI-CTC V4.0) during prior oxaliplatin-based chemotherapy
• Any prior chemotherapy for metastatic disease
• Previous treatment with EGFR antibodies
• Prior non-colorectal malignancies, except adequately treated basalioma of the skin or carcinoma in situ of the cervix.
• Bleeding diathesis or coagulation disorders
• Females with a positive pregnancy test (within 14 days before treatment start) or breast feeding
• Fertile women (\<2 years after last menstruation) and women of childbearing potential not willing to use effective means of contraception
• History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for drug intake
• Clinically significant (i.e. active) cardiovascular disease, e.g. cerebrovascular accidents (\<6 months prior to randomization), myocardial infarction (\<1 year prior to randomization), Congestive heart failure (NYHA Grades III or IV), uncontrolled hypertension while receiving chronic medication, unstable angina pectoris, significant arrhythmia
• Known peripheral neuropathy, including oxaliplatininduced

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Department of Surgery, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Interventions

Folfox protocol; Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ulf P Neumann, Prof.

  RWTH Aachen University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 24, 2010
• Study Start: July 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

DE (1)