Reduced Radiotherapy With Pac/Cis vs Standard Radiotherapy With 5-FU/Cis in Locally Advanced Head and Neck Cancer

• Status: Terminated
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Erlangen-Nürnberg Medical School
• Collaborator: Deutsche Krebshilfe e.V., Bonn (Germany)
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Fluorouracil; Paclitaxel

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