Reduced RT with Pac/Cis vs. standard RCT with 5-FU/Cis
Standard treatment for patients with advanced, unresectable head and neck cancer is a platin-based simultaneous radiochemotherapy (RCT) (Pignon JP et al., Lancet 2000;355:949-955). However, irradiation dose is still debatable regarding local tumor control and late toxicity. Moreover, it is still unclear which combination of different drugs might be more effective. In recent years, new drugs have been introduced in the field of head and neck cancer. The Taxanes, namely Docetaxel and Paclitaxel, have been investigated in several phase I/II-studies, and showed promising results concerning locoregional control rates and survival data. The RTOG 97-03 trial (Garden et al., J Clin Oncol 2004; 22:2856-64) compared a RCT either with Cisplatin/5-FU or Cisplatin/Paclitaxel. In this phase II-study an improvement of local tumor control and disease free survival of 15-20% in favour of the Cisplatin/Paclitaxel treatment arm was seen. Therefore, our phase III-trial compares a standard RCT (70.6 Gy) with Cisplatin/5-FU to a RCT with Cisplatin/Paclitaxel and reduced irradiation dose (63.6 Gy). Primary endpoint is to proof superiority of the experimental Cisplatin/Paclitaxel treatment arm concerning disease-free-survival. Secondary endpoints are locoregional tumor control, overall survival and quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
221
Experimental: Paclitaxel (20mg/m\^2/d) on days 2, 5, 8, 11 and 25, 30, 33, 36) and Cisplatin (20mg/m\^2/d) on days 1-4 and 29-32,
Experimental: 63,6 Gy accelerated hyperfractionated radiotherapy
Active Comparator: 5-Fluorouracil(600mg/m\^2/d) on days 1-5 and 29-33) and Cisplatin (20mg/m\^2/d) on days 1-5 and 29-33
Klinikum Coburg, Strahlentherapie, DiaCura
Coburg, Germany
Universitätsklinikum Düsseldorf, Klinik und Poliklinik für Strahlentherapie und Radiologische Onkologie
Düsseldorf, Germany
Disease free survival
Time frame: 3 years
Overall Survival
Time frame: 3 years
Distant metastasis free survival
Time frame: 3 years
Local control
Time frame: 3 years
Acute and Late Toxicity
Time frame: 4 years
Life Quality
Time frame: 4 years
HPV/p16-Status
Time frame: End of study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Active Comparator: 70,6 Gy accelerated hyperfractionated radiotherapy
Universitätsklinikum Erlangen, Strahlenklinik
Erlangen, Germany
Universitätsklinikum Frankfurt, Klinik für Strahlentherapie und Radioonkologie
Frankfurt/M., Germany
Klinikum am Eichert, Praxis für Strahlentherapie und Klinik für Radioonkologie
Göppingen, Germany
Universitätsklinikum des Saarlandes, Klinik für Strahlentherapie und Radioonkologie,
Homburg/Saar, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik und Poliklinik für Hals-Nasen- und Ohrenkranke
Lübeck, Germany
Kliniken Maria Hilf GmbH Mönchengladbach, Klinik für Strahlentherapie
Mönchengladbach, Germany
Klinikum München Pasing und Perlach, Klinik für HNO
München, Germany
Brüderkrankenhaus st. Josef Paderborn, Klinik für Strahlentherapie
Paderborn, Germany
...and 3 more locations