Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Locally Advanced Head and Neck Cancer Stages III and IV A-B

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free survival

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Rainer Fietkau, MD

Investigator Role:

Study Director

Investigator Affiliation:

Strahlenklinik, Universitätsklinikum Erlangen

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

Paccis-RCT_2005

NCT ID:

NCT01126216

Start Date:

May 2010

Completion Date:

June 2018

Related Keywords:

  • Locally Advanced Head and Neck Cancer Stages III and IV A-B
  • Radiochemotherapy
  • head and neck cancer
  • Paclitaxel
  • Cisplatin
  • 5-FU
  • Head and Neck Neoplasms

Name

Location