PacCis-RCT

Phase 1

• Conditions: Head and Neck cancer, Stage III-IV A-B; MedDRA version: 18.0 Level: LLT Classification code 10026518 Term: Malignant neoplasm of supraglottis stage III System Organ Class: 100000004864; MedDRA version: 18.0 Level: LLT Classification code 10026185 Term: Malignant neoplasm of oropharynx, unspecified System Organ Class: 100000004864; MedDRA version: 18.0 Level: LLT Classification code 10041862 Term: Squamous cell carcinoma of the oral cavity stage III System Organ Class: 100000004864; MedDRA version: 18.0 Level: LLT Classification code 10041863 Term: Squamous cell carcinoma of the oral cavity stage IV System Organ Class: 100000004864; MedDRA version: 18.0 Level: LLT Classification code 10041855 Term: Squamous cell carcinoma of the hypopharynx stage IV System Organ Class: 100000004864; MedDRA version: 18.0 Level: LLT Classification code 10041854 Term: Squamous cell carcinoma of the hypopharynx stage III System Organ Class: 100000004864; MedDRA version: 18.0 Level: LLT Classification code 10026519 Term: Malignant neoplasm of supraglottis stage IV System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2005-003484-23-DE
• Lead Sponsor: niversitätsklinikum Erlangen, Strahlenklinik insoweit handelnd für den Freistaat Bayern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-16
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 542

Inclusion Criteria

1. 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
2. Age = 18
3. Written informed consent for the participation in the clinical trial

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 542
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 542

Exclusion Criteria

1. Unadequate hepatic function:
Bilirubin > 2,0 mg/dl, SGOT, SGPT, AP, Gamma-GT > 3 x ULN
2. Unadequate bone marrow function:
Leukocytes < 3,5 x 10^9/l, Platelets < 100 x 10^9/l or Neutrophile < 1,5 x 10^9/l
3. Serum creatinine > 1,5 mg/dl, Creatinine-clearance < 60ml/min
4. Uncontrolled severe somatic or psychological disease:
- 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
5. Acute infections
6. 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 teh Note for guidance on non-clinical safety studies for the conduct of human clinical reials for pharmaceuticals (CPMP/ICH/286/95 mod) and it has to be discussed with the investigator)
7. Pregnant or breast feeding women
8. Men, who are not willing to use adequate contraception during and up to 6 months after therapy, that is discussed with the investigator
9. ECOG-Status > 1
10. Reduced hearing function (especially higher frequencies)
11. Exsiccose
12. Neuropathy, caused by cisplatin
13. Concurrent malignancies, with exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma or the cervix
14. Prior radiotherapy of the neck or chemotherapy
15. Distant metastasis
16. Recurrent carcinoma in the head and neck region
17. Prior neck-dissection or surgical intervention exceeding an exploratory excision
18. Known intolerance to 5-Fluorouracil
19. Known deficite of Dihydropyrimidindehydrogenase (DPD)
20. Simultaneous therapy with Brivudin or other inhibitors of DPD
21. Known intolerance to Cisplatin or other substances that contain platin
22. Known intolerance to Paclitaxel or one of the included substances, especially to Poly(oxyethylen)-35-Rhizinusöl/Macrogolglycerolricinoleat

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: To investigate the superiority of dose reduced radiotherapy (63.6 Gy) with Paclitaxel/Cisplatin versus standard radiotherapy (70.2 Gy) with 5-FU/Cisplatin:<br> NED-Survival<br> ;<br> Secondary Objective: Overall survival<br> Locoregional tumor control rate<br> Quality of life<br> ;Primary end point(s): Disease-free survival;Timepoint(s) of evaluation of this end point: 4 years after end of RCT

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Overall survival<br> Disease free survival<br> Locoregional tumor control rate<br> Acute and long term toxicity<br> Quality of life<br> Analysis of HPV/p16-status<br> ;Timepoint(s) of evaluation of this end point: 4 years after end of RCT