MedTrace Logo

Treatment Selection According to Skin Reaction to Cetuximab

NCT01472653 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2011-12-13

No results posted yet for this study

Summary

The therapy of patients with locally advanced head and neck cancer will be adjusted to the grade of skin rush as recorded after the first two cycles of Cetuximab and Cisplatin, i.e. either with radioimmunotherapy (radiotherapy and Cetuximab) or radiochemotherapy (radiotherapy and Cisplatin.

Conditions

Interventions

DRUG

cisplatin

cisplatin 30 mg/m2/week I.V. during radiotherapy

RADIATION

radiotherapy

3-dimensional conformal radiotherapy planning and delivery, 35x2 Gy/day over 7 weeks

DRUG

cetuximab

cetuximab 400 mg/m2 I.V. 1 week before the start of radiotherapy, cetuximab 250 mg2/week I.V. during radiotherapy

Sponsors & Collaborators

  • Institute of Oncology Ljubljana

    lead OTHER

Principal Investigators

  • Primož Strojan, Prof. · Dept. of Radiation Oncology, Institute of Oncology Ljubljana, Slovenia

  • Branko Zakotnik, Prof. · Dept. of Medical Oncology, Institute of Oncology Ljubljana, Slovenia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-03-31
Completion
2016-12-31

Countries

  • Slovenia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01472653 on ClinicalTrials.gov