Trial document

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Trial Description

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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

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Trial Acronym


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URL of the Trial


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Brief Summary in Lay Language

This is an open-label, randomized, Phase II-study to evaluate the efficacy of a standard-TPF
induction chemotherapy (IC) and an alternative TPF induction chemotherapy followed by
radio-antibody-therapy, in patients with unresectable LA-SCC of the HN region
(oro-hypopharynx carcinoma, cancer of the oral cavity).

The primary objective of the study is to assess the feasibility of an experimental
'fractionated' TPF regimen compared to a current standard TPF regimen.

Composite endpoint of compliance and feasibility in terms of

- response (RECIST1.1) and

- hematological acute toxicity (CTCAE v.4.02)

- on time application of RAT following an experimental or standard TPF IC.

Secondary endpoints are

- Treatment intensity achieved

- Toxicity (according to CTCAE v.4.02)

- Response rates after completion of induction chemotherapy and after completion of
entire protocol treatment (RECIST1.1)

- Survival (progression-free, metastasis-free, recurrence-free, overall) 1 year after

- Quality of life according to EORTC QoL C30 & HN35

The study will be conducted at 5-6 investigational sites in Germany recruiting 90 patients
in total. Eligible patients will have a diagnosis of histologically confirmed SSC of the HN.
Patients will receive one of 2 different regimens of TPF IC followed by cetuximab together
with radiotherapy (RAT) or a standard radiochemotherapy(RCT) regimen.

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Brief Summary in Scientific Language


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Do you plan to share individual participant data with other researchers?


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Description IPD sharing plan:


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Organizational Data

  •   DRKS00005568
  •   2014/03/26
  •   2010/08/12
  •   yes
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Secondary IDs

  •   2010-019347-18 
  •   NCT01181401  (
  •   EudraCT No. 2010-019347-18  (Charite University, Berlin, Germany)
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Health Condition or Problem studied

  •   Squamous Cell Carcinoma of the Head
  •   Squamous Cell Carcinoma of the Neck
  •   C01 -  Malignant neoplasm of base of tongue
  •   C02 -  Malignant neoplasm of other and unspecified parts of tongue
  •   C03 -  Malignant neoplasm of gum
  •   C04 -  Malignant neoplasm of floor of mouth
  •   C05 -  Malignant neoplasm of palate
  •   C06 -  Malignant neoplasm of other and unspecified parts of mouth
  •   C10 -  Malignant neoplasm of oropharynx
  •   C13 -  Malignant neoplasm of hypopharynx
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Interventions/Observational Groups

  •   Drug: TPF induction chemotherapy
  •   Drug: TPF experimental
  •   Radiation: Standard Radiochemotherapy (HART)
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  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- Feasibility of an experimental 'fractionated' TPF regimen compared to a current standard TPF regimen.; time frame: August 2010- December 2012; acute hematological toxicity

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Secondary Outcome

- Survival and late morbidity; time frame: 1 year; All adequate items illustrating acute toxicity and late morbidity, in particular by hematological measures until one year after treatment (according to NCI-CTCAE v.4.02) Survival (progression-free, metastases-free, recurrence-free, Overall survival) after 1 year Response rates after TPF IC (RECIST1.1) Response rates after completion of multimodal treatment (see follow-up for scheduling RECIST1.1) Efficacy in relation to HPV status (p16 IHC) Quality of life according to EORTC QLC-30 & HN35

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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  •   [---]*
  •   2010/08/31
  •   90
  •   Multicenter trial
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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.

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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

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  • start of 1:1-Block address primary-sponsor
    • Charite University, Berlin, Germany
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    • Charité Universitaetsmedizin Berlin
    • Volker Budach, MD, PhD 
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    • Carmen Stromberger, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704.; 17960012
  •   Posner MR, Hershock DM, Blajman CR, Mickiewicz E, Winquist E, Gorbounova V, Tjulandin S, Shin DM, Cullen K, Ervin TJ, Murphy BA, Raez LE, Cohen RB, Spaulding M, Tishler RB, Roth B, Viroglio Rdel C, Venkatesan V, Romanov I, Agarwala S, Harter KW, Dugan M, Cmelak A, Markoe AM, Read PW, Steinbrenner L, Colevas AD, Norris CM Jr, Haddad RI; TAX 324 Study Group. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1705-15.; 17960013
  •   Haddad R, Colevas AD, Tishler R, Busse P, Goguen L, Sullivan C, Norris CM, Lake-Willcutt B, Case MA, Costello R, Posner M. Docetaxel, cisplatin, and 5-fluorouracil-based induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck: the Dana Farber Cancer Institute experience. Cancer. 2003 Jan 15;97(2):412-8.; 12518365
  •   Bonner JA, Harari PM, Giralt J, Cohen RB, Jones CU, Sur RK, Raben D, Baselga J, Spencer SA, Zhu J, Youssoufian H, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol. 2010 Jan;11(1):21-8. Epub 2009 Nov 10. Erratum in: Lancet Oncol. 2010 Jan;11(1):14.; 19897418
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  •   1
  •   2013/12/01
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