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behandling af patienter med avanceret rectumcancer med capecitabin og oxaliplatin før under og efter kurativt intenderet strålebehandling, samt tillæg af cetuximab til patienter der er K-RAS vild-type

behandling af patienter med avanceret rectumcancer med capecitabin og oxaliplatin før under og efter kurativt intenderet strålebehandling, samt tillæg af cetuximab til patienter der er K-RAS vild-type

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-010976-94-DK
Enrollment
60
Registered
2009-06-08
Start date
2009-07-16
Completion date
Unknown
Last updated
2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

we will give capecitabine and oxaliplatin togehter with radiation to patient with rectum cancer T3 and T4. We will add cetuximab to patients who are K-RAS wild-type MedDRA version: 9.1 Level: LLT Classification code 10002124 Term: Anal canal cancer

Interventions

Trade Name: Erbitux 5mg/ml Pharmaceutical Form: Solution for infusion INN or Proposed INN: not known CAS Number: not known Current Sponsor code: no sponsor Other descriptive name: no Concentration uni

Sponsors

herlev hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Non-resectable rectum cancer T3 and T4, PS 0-1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Expected lifetime less than 3 month No concurrent disease

Design outcomes

Primary

MeasureTime frame
Main Objective: evaluate response to the treatment;Secondary Objective: safety;Primary end point(s): response rate—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026