NCT01511146

Brief Summary

The purpose of this study is to see if treatment with intrahepatic chemotherapy is a good options in patients with liver metastases. If the patients have colorectal cancer and never had got chemotherapy the investigators will use oxaliplatin together with capecitabine. If the patient is K-RAS wild type the investigators will add cetuximab. In patients who had received oxaliplatin or in patients with other cancers the investigators will use mitomycin and gemcitabine together with capecitabine.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 18, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 19, 2012

Status Verified

January 1, 2012

Enrollment Period

4 years

First QC Date

August 4, 2011

Last Update Submit

January 18, 2012

Conditions

Liver Metastasis

Keywords

oxaliplatinmitomycingemcitabineintrahepaticliver metastasisresponse in liver metastasisdownsized to operation

Outcome Measures

Primary Outcomes (1)

  • tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded.

    5 years

Secondary Outcomes (1)

  • Progression free survival, adverse events

    5 years

Study Arms (1)

Mitomycin+Gemcitabine

EXPERIMENTAL

Intrahepatic treatment, where all standard treatments have been used

Drug: OxaliplatinDrug: Mitomycin + Gemcitabine

Interventions

OxaliplatinDRUG

oxaliplatin 85 mg/m2 in 10 minutes

Also known as: Mitomycin c, Gemcitabine
Mitomycin+Gemcitabine
Mitomycin + GemcitabineDRUG

Mitomycin 5 mg/m2 Gemcitabine 1000 mg/m2

Also known as: Mitomycin c, Gemcitabine
Mitomycin+Gemcitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • liver metastasis
  • solid tumor

You may not qualify if:

  • poor performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Interventions

OxaliplatinMitomycinGemcitabine

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsMitomycinsIndolequinonesQuinonesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxycytidineCytidinePyrimidine NucleosidesPyrimidines

Study Officials

  • Finn O Larsen, M.D., Ph.D

    Unaffliated

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2011

First Posted

January 18, 2012

Study Start

July 1, 2011

Primary Completion

July 1, 2015

Study Completion

July 1, 2016

Last Updated

January 19, 2012

Record last verified: 2012-01

Locations

DK(1)