NCT01108107

Brief Summary

This study will investigate

  • the effect of preoperative combination chemotherapy in patients with locally advanced colon cancer with mutation in the KRAS, BRAF or PIK3CA gene
  • the effect of preoperative combination chemotherapy in combination with biological treatment in patients without mutation in the KRAS, BRAF or PIK3CA gene.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

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

April 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 21, 2015

Status Verified

March 1, 2014

Enrollment Period

3.4 years

First QC Date

April 14, 2010

Last Update Submit

May 20, 2015

Conditions

Colon Cancer

Keywords

Colon cancerNeoadjuvant treatmentKRAS mutationBRAF mutationPIK3CA mutationPossibly avoid chemotherapy after operation

Outcome Measures

Primary Outcomes (1)

  • The frequency of patients requiring adjuvant chemotherapy based on the histological evaluation of the preparation from the operation.

    Within 1 week after surgery

Secondary Outcomes (2)

  • Recurrence free survival

    Up to 2 years.

  • Overall survival

    Up to 2 years.

Study Arms (2)

Chemotherapy only

OTHER

Chemotherapy only, if mutations in KRAS, BRAF or PIK3CA gene

Drug: OxaliplatinDrug: Capecitabine

Chemotherapy + biological treatment

OTHER

Addition of biological treatment, if no mutations in KRAS, BRAF, and PIK3CA genes.

Drug: OxaliplatinDrug: CapecitabineBiological: Panitumumab

Interventions

OxaliplatinDRUG

130 mg/m2 intravenously on day 1 of a 3-weekly cycle

Chemotherapy only
CapecitabineDRUG

2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle

Chemotherapy only
PanitumumabBIOLOGICAL

9 mg/kg intravenously on day 1 of a 3-weekly cycle

Chemotherapy + biological treatment

Eligibility Criteria

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

You may qualify if:

  • Histologically verified locally advanced T3 or T4 colon cancer assessed by CT scan
  • Analysis of KRAS, BRAF, PIK3CA
  • Age ≥18 år
  • Performance status ≤ 2
  • Hematology
  • ANC ≥ 1.5x10\^9/l. Thrombocytes ≥ 100x10\^9/l.
  • Biochemistry
  • Bilirubinaemia ≤ 3 x UNL. ALAT ≤ 5 x UNL
  • Consent to translational research
  • Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
  • Written and orally informed consent.

You may not qualify if:

  • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment, active severe infections or other concurrent disease.
  • Peripheral neuropathy NCI grade \>1
  • Other malignant disease within 5 years prior to enrollment, except basal cell squamous carcinoma of the skin and cervical carcinoma-in-situ
  • Other investigational treatment within 30 days prior to treatment start
  • History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
  • Bleeding tumors
  • Hypersensitivity to one or more of the substances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Oncology, Herlev Hospital

Herlev, DK-2730, Denmark

Location

Dept. of Oncology, Hilleroed Hospital

Hilleroed, 3400, Denmark

Location

Department of Oncology, Vejle Hospital

Vejle, DK-7100, Denmark

Location

Related Publications (1)

  • Dam C, Lund-Rasmussen V, Ploen J, Jakobsen A, Rafaelsen SR. Computed tomography assessment of early response to neoadjuvant therapy in colon cancer. Dan Med J. 2015 Jul;62(7):A5103.

    PMID: 26183044DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

OxaliplatinCapecitabinePanitumumab

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Anders Jakobsen, DMSc

    Vejle Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2010

First Posted

April 21, 2010

Study Start

April 1, 2010

Primary Completion

September 1, 2013

Study Completion

March 1, 2015

Last Updated

May 21, 2015

Record last verified: 2014-03

Locations

DK(3)