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Randomized Phase II Study of Two Different Regimens of TPF Induction Chemotherapy Regimen Followed by Radiation Therapy Plus Cetuximab (TPF-CET-HART) vs. HART and Cis-platinum, 5-FU (PF-HART) in Patients With Locally Advanced Unresectable Squamous Cell Carcinomas of the Head and Neck


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Squamous Cell Carcinoma of the Head, Squamous Cell Carcinoma of the Neck

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Trial Information

Randomized Phase II Study of Two Different Regimens of TPF Induction Chemotherapy Regimen Followed by Radiation Therapy Plus Cetuximab (TPF-CET-HART) vs. HART and Cis-platinum, 5-FU (PF-HART) in Patients With Locally Advanced Unresectable Squamous Cell Carcinomas of the Head and Neck


Inclusion Criteria:



- Histologically proven unresectable SCC of the oral cavity, oropharynx and
hypopharynx (stage IVA & IVB)

- Written and signed informed consent

- Karnofsky PS > 70 %

- Age ≥ 18 years

- Curative treatment intent

- Adequate bone marrow, hepatic and renal functions as evidenced by the following:

Hematology (Bone marrow):

- Neutrophils > 2.0 109/L

- Platelets > 100 x 109/L

- Hemoglobin > 10 g/dL

Hepatic function:

- Total serum bilirubin < 1 time the UNL of the participating center

- ASAT (SGOT) and ALAT (SGPT) < 2.5 x UNL

- Alkaline phosphatase < 5 x UNL

Renal function :

- serum creatinine (SC) < 120 µmol/L (1.4 mg/dl);

- if values are > 120 µmol/L, the creatinine clearance should be > 60 ml/min (actual
or calculated by the Cockcroft-Gault method as follows :

weight (kg) x (140 - age) --------------------------------- K x serum creatinine

serum creatinine in mg/dL: K = 72 in man K = 85 in woman serum creatinine in µmol/L: K =
0.814 in man K = 0.96 in woman

• If of childbearing potential, willingness to use effective contraceptive method for the
study duration and 2 months post-dosing.

All patients require:

- dental examination and appropriate dental preservation if needed 1 week prior to the
beginning of radiotherapy,

- gastric feeding tube and Portal-catheter.

Exclusion Criteria:

- Other neoplasia within the past 5 years with the exception of a controlled skin
cancer or "in situ" cervix cancer

- Unknown primary (CUP), nasopharynx, laryngeal or salivary gland cancer

- Distant metastatic disease (M1)

- Serious co-morbidity, e.g. arteriosclerosis with apoplexy, recent myocardial
infarction, high-grade carotid stenoses, unstable cardiac disease despite treatment,
congestive heart failure NYHA grade 3 and 4, insulin-dependent diabetes mellitus,
uncontrolled hypertension, liver cirrhosis (Quick < 75%, total protein <3.0 g/dl,
bilirubin >2mg/ml) or kidney insufficiency (creatinine >1.4 mg/ml, the creatinine
clearance should be > 60 ml/min)

- patients with ASAT or ALAT > 2.5 UNL associated with alkaline phosphatase > 5 UNL are
not eligible for the study

- Known HIV-infection

- Pregnancy or lactation

- Women of child-bearing potential with unclear contraception

- Previous treatment of the disease with chemotherapy, radiotherapy, EGFR-targeting
agents or surgery exceeding biopsy in head and neck

- Concurrent treatment with other experimental drugs or participation in another
clinical trial with any investigational drug within 30 days prior to study screening

- Social situations that limit compliance with study requirements

- Deficient dental preservation status or not accomplished wound healing

- Legal incapacity

- Prior accommodation in an institution under officially or judicially orders (§ 40 1
p. 3 No. 4 AMG)

- Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria
(NCI-CTC) grade 2 and/or ototoxicity grade 2, except if due to trauma or mechanical
impairment due to tumor mass

- Known allergic/hypersensitivity reaction to any of the components of the treatment

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Feasibility of an experimental 'fractionated' TPF regimen compared to a current standard TPF regimen.

Outcome Description:

acute hematological toxicity

Outcome Time Frame:

August 2010- December 2012

Safety Issue:

Yes

Principal Investigator

Volker Budach, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charité Universitaetsmedizin Berlin

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

EudraCT No. 2010-019347-18

NCT ID:

NCT01181401

Start Date:

August 2010

Completion Date:

December 2012

Related Keywords:

  • Squamous Cell Carcinoma of the Head
  • Squamous Cell Carcinoma of the Neck
  • induction chemotherapy
  • radiotherapy
  • locally advanced head neck tumor
  • toxicity
  • LA SCCHN
  • Unresectable squamous cell cancer of the head and neck,
  • Stage IV (UICC)
  • Carcinoma
  • Carcinoma, Squamous Cell

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