Reduced Radiotherapy With Pac/Cis vs Standard Radiotherapy With 5-FU/Cis in Locally Advanced Head and Neck Cancer
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
Radiochemotherapy, head and neck cancer, Paclitaxel, Cisplatin, 5-FU
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Paclitaxel/Cisplatin Type: Drug
Name: Reduced RT Type: Radiation
Name: 5-FU/Cisplatin Type: Drug
Name: Standard RT Type: Radiation
Overall Status
Recruiting
Summary
Reduced RT with Pac/Cis vs. standard RCT with 5-FU/Cis
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically proven, locally advanced stage III-IV A-B (UICC 2002) primary squamous cell carcinoma of the oral cavity, the oropharynx, the hypopharynx, the supraglottic larynx

- Age ≥ 18

- Written informed consent for the participation in the clinical trial

Exclusion Criteria:

- Inadequate hepatic function: Bilirubin > 2,0 mg/dl, SGOT, SGPT, AP, Gamma-GT > 3 x ULN

- Inadequate bone marrow function: leukocytes < 3,5 x 10^9/l, platelets < 100 x 10^9/l or neutrophils < 1,5 x 10^9/l

- Serum creatinine > 1,5 mg/dl, creatinine clearance < 60ml/min

- Uncontrolled severe somatic or psychological disease: e.g. unstable angina pectoris; myocardial infarction during the last 6 months; significant cardial rhythm disorders; apoplexy; high grade stenosis of the carotis; neurological or psychiatric disorders including convulsive disorders; dementia; psychosis; active uncontrolled infection or sepsis; liver cirrhosis; Child stage B,C; severe liver function disorders; marginal changes in the blood count; severe kidney damage; HIV-infection

- Acute infections

- Fertile women without adequate contraception during and up to 6 months after therapy (the method of contraception has to be high effective as described in the Note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (CPMP/ICH/286/95 mod) and it has to be discussed with the investigator)

- Pregnant or breast feeding women

- Men, who are not willing to use adequate contraception during and up to 6 months after therapy, that is discussed with the investigator

- ECOG-Status > 1

- Reduced hearing function (especially higher frequencies)

- Exsiccosis

- Neuropathy, caused by cisplatin

- Concurrent malignancies, with exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma or the cervix

- Prior radiotherapy of the neck or chemotherapy

- Distant metastasis

- Recurrent carcinoma in the head and neck region

- Prior neck-dissection or surgical intervention exceeding an exploratory excision

- Known intolerance to 5-Fluorouracil

- Known deficit of Dihydropyrimidine dehydrogenase (DPD)

- Simultaneous therapy with Brivudin or other inhibitors of DPD

- Known intolerance to Cisplatin or other substances that contain platin

- Known intolerance to Paclitaxel or one of the included substances, especially to Poly(oxyethylene)Rhizinusöl/Macrogolglycerol ricinoleate
Locations
Klinikum Coburg, Strahlentherapie, DiaCura
Coburg, Germany
Status: Recruiting
Universitätsklinikum Düsseldorf, Klinik und Poliklinik für Strahlentherapie und Radiologische Onkologie
Düsseldorf, Germany
Status: Recruiting
Universitätsklinikum Erlangen, Strahlenklinik
Erlangen, Germany
Status: Recruiting
Universitätsklinikum Frankfurt, Klinik für Strahlentherapie und Radioonkologie
Frankfurt/M., Germany
Status: Recruiting
Klinikum am Eichert, Praxis für Strahlentherapie und Klinik für Radioonkologie
Göppingen, Germany
Status: Recruiting
Universitätsklinikum des Saarlandes, Klinik für Strahlentherapie und Radioonkologie,
Homburg/Saar, Germany
Status: Recruiting
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik und Poliklinik für Hals-Nasen- und Ohrenkranke
Lübeck, Germany
Status: Recruiting
Kliniken Maria Hilf GmbH Mönchengladbach, Klinik für Strahlentherapie
Mönchengladbach, Germany
Status: Recruiting
Klinikum München Pasing und Perlach, Klinik für HNO
München, Germany
Status: Recruiting
Brüderkrankenhaus st. Josef Paderborn, Klinik für Strahlentherapie
Paderborn, Germany
Status: Recruiting
Universitätsklinikum Regensburg, Klinik und Poliklinik für Strahlentherapie
Regensburg, Germany
Status: Recruiting
Universitätsklinikum Rostock, Klinik und Poliklinik für Stahlentherapie
Rostock, Germany
Status: Withdrawn
Klinikum St. Elisabeth Straubing, Klinik für Hals-Nasen-Ohren-Heilkunde
Straubing, Germany
Status: Recruiting
MVZ am Klinikum Mutterhaus der Borrmäerinnen, Strahlentherapie
Trier, Germany
Status: Recruiting
Start Date
May 2010
Completion Date
June 2018
Sponsors
University of Erlangen-Nürnberg Medical School
Source
University of Erlangen-Nürnberg Medical School
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page