This trial is active, not recruiting.

Condition head and neck cancer
Treatments paclitaxel/cisplatin, reduced rt, 5-fu/cisplatin, standard rt
Phase phase 3
Sponsor University of Erlangen-Nürnberg Medical School
Collaborator Deutsche Krebshilfe e.V., Bonn (Germany)
Start date May 2010
End date February 2015
Trial size 542 participants
Trial identifier NCT01126216, 107028, 2005-003484-23, Paccis-RCT_2005


Reduced RT with Pac/Cis vs. standard RCT with 5-FU/Cis

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
63,6 Gy accelerated hyperfractionated radiotherapy with 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, followed by a salvage operation or neck dissection if there is persisting tumor
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,
reduced rt
Experimental: 63,6 Gy accelerated hyperfractionated radiotherapy
(Active Comparator)
70,6 Gy accelerated hyperfractionated radiotherapy with 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, followed by a salvage operation or neck dissection if there is persisting tumor
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
standard rt
Active Comparator: 70,6 Gy accelerated hyperfractionated radiotherapy

Primary Outcomes

Disease free survival
time frame: 3 years

Secondary Outcomes

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
time frame: End of study

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Randomised Phase-III-trial of Simultaneous Radiochemotherapy (RCT) of Locally Advanced Head and Neck Cancer in the Stages III and IV A-B: Comparing Dose Reduced Radiotherapy (63,6 Gy) With Paclitaxel/Cisplatin to Standard Radiotherapy (70,2 Gy) With 5-Fluorouracil/Cisplatin
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Erlangen-Nürnberg Medical School.