Trial document

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Trial Description

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Multicenter, Open-label Phase II Trial on Post-surgery Chemoradiation in Combination With Cetuximab in Squamous Cell Carcinoma of the Head and Neck With High Risk of Locoregional Recurrence.

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Trial Acronym


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URL of the Trial


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Brief Summary in Lay Language

This multicenter, open-label, uncontrolled phase II trial evaluates safety and efficacy of
post-operative chemoradiation in combination with cetuximab in squamous cell carcinoma of
the head and neck.

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Brief Summary in Scientific Language

Advanced squamous cell carcinoma of the head and neck still has a poor prognosis and
loco-regional recurrence frequently occurs. Efforts have been made to improve response rates
and survival and different therapeutic regimens including concurrent chemo-radiotherapy or
sequential chemo-radiotherapy have been developed.

To further increase the outcome of patients with locally advanced SCCHN effective new
treatments with minimal toxicities are needed. Molecular targeted agents, which do not
demonstrate overlapping toxicities with commonly used chemotherapy agents, have therefore
been investigated. The EGFR is widely expressed at high levels in SSCHN and is associated
with poor prognosis.

Cetuximab has already been investigated in combination with radiotherapy or chemotherapy in
patients with head and neck cancer. The immunoradiotherapy was well tolerated with most of
the side effects related to the high dose irradiation. The most common side effects are
mucositis and dysphagia. Additionally, skin reactions appear sometimes more frequently in
cetuximab administration. Grade 3 to 4 infusion reactions were observed in 3% of the
patients treated with cetuximab. Based on the current promising results with RCT in patients
with locally advanced head and neck cancer and clinical results with EGFR-antibodies plus
RT, the present study was primarily designed to define the acute grade 3/4 toxicity.

We expect to show effective results in reducing the risk of distant metastasis, with
administration of an additional six month adjuvant cetuximab treatment, in patient with
recurrent SCCHN.

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Organizational Data

  •   DRKS00003939
  •   2012/05/09
  •   2008/11/13
  •   yes
  •   Approved
  •   MC-LKP_233, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

  •   NCT00791141  (
  •   ACCRA-HN  (Heinrich-Heine University, Duesseldorf)
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Health Condition or Problem studied

  •   Head and Neck Cancer
  •   C13 -  Malignant neoplasm of hypopharynx
  •   C10 -  Malignant neoplasm of oropharynx
  •   C32 -  Malignant neoplasm of larynx
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Interventions/Observational Groups

  •   Drug: Cetuximab
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  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

- Rate of patients experiencing grade 3/4 acute toxicities not considering grade 3/4 skin tox. outside the radiation portals combined with 2-years disease-free survival rate.; time frame: any toxicities occurring within 90 days post radiation start

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Secondary Outcome

- Incidence of Loco-regional relapse; time frame: assessment after patient has completed follow-up
- Disease-free survival; time frame: time from start of surgery to the first evidence of loco-regional or distant tumor relapse or death
- Progression-free survival; time frame: from start of surgery to the first observation of disease progression or death
- Overall survival; time frame: censored at the time of last documented efficacy
- The rate of patients with secondary primary neoplasm; time frame: assessment after patient has completed follow-up
- The incidence of late toxicity; time frame: beyond 90 days after start of radiation therapy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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  •   [---]*
  •   2008/08/31
  •   80
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

- Signed written informed consent;

- Males or females between 18 and 70 years of age;

- Surgically resected squamous cell carcinomas of the hypopharynx, oropharynx, larynx
and oral cavity with high risk of locoregional recurrence not more than 6-9 weeks
(maximum) ago;

- To be categorized as high risk patients have to fulfil at least one of the following

- R0 - resection <5 mm margin

- R1 - resection

- Extracapsular nodal extension;

- no previous chemotherapy, radiotherapy;

- Performance status ECOG: 0 - 1;

- Contraception in male and female patients if of childbearing potential, willingness
to use effective contraceptive method for the study duration and 2 months

- Adequate renal, liver and hematological functions (within maximum 9 weeks until

- Adequate bone marrow function: neutrophils > 1.5 x 10^9/L, platelets > 100 x
10^9/L, hemoglobin > 10.0 g/dL

- Adequate liver function: Bilirubin < 2.0 mg/dL, AST, ALT, AP, γ-GT < 3 x ULN

- Adequate renal function: creatinine clearance > =60 ml/min

- No distant metastases;

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Exclusion Criteria

- Nasopharyngeal carcinoma;

- R2 resection;

- Invalid informed consent;

- Performance Status > 1;

- Previous chemotherapy or radiotherapy for carcinoma of the head and neck;

- Prior exposure to EGFR pathway targeting therapy;

- Other serious illness or medical conditions:

- Unstable cardiac disease despite treatment, congestive heart failure NYHA grade
3 and 4;

- Clinically significantly abnormal electrocardiogram (ECG) or left ventricular
ejection fraction (LVEF) below the institutional range of the normal

- Significant neurologic or psychiatric disorders including dementia or seizures;

- Active uncontrolled infection;

- Active disseminated intravascular coagulation;

- Other serious underlying medical conditions which could impair the ability of
the patient to participate in the study;

- Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria
(NCI-CTC v3.0) grade 2 or ototoxicity grade 2, except if due to trauma or mechanical
impairment due to tumor mass;

- Having participated in another therapeutic clinical trial or any investigational
agent in the preceding 30 days;

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

- Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding;

- Known drug abuse;

- Other previous malignancy within 5 years, with exception of a history of a previous
basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix;

- Legal incapacity or limited legal capacity;

- Sensitivity and incompatibility against 5-Fluorouracil

- Sensitivity and incompatibility against platinum-compounds

- Known incompatibilities >grade 3 towards cetuximab

- expected incompliance of patient (e.g. in case of severe alcohol addiction)

- Dental evaluation: Pre treatment dental care before start of radiochemotherapy
(approximately 8 to 10 days lapse-time is needed for complete recovery before
initiation of radiation therapy).

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  • start of 1:1-Block address primary-sponsor
    • Heinrich-Heine University, Duesseldorf
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    • Department of Radiotherapy and Radiological Oncology
    • Wilfried Budach, Prof. Dr. 
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    • Department of Radiotherapy and Radiological Oncology
    • Wilfried Budach, Prof. Dr. 
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    •   [---]*
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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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  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

  •   Budach W, Bölke E, Homey B. Severe cutaneous reaction during radiation therapy with concurrent cetuximab. N Engl J Med. 2007 Aug 2;357(5):514-5. No abstract available.; 17671265
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The parameters in and DRKS are not identical. Therefore the data import from required adjustments. For full details please see the DRKS FAQs .
  •   8
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.