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Cetuximab & Concomitant-Boost Accelerated RT in Patients With Locally Advanced Oropharynx Squamous Cell Carcinoma.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00251381
Recruitment Status : Unknown
Verified October 2006 by Trial Form Support S.L..
Recruitment status was:  Recruiting
First Posted : November 10, 2005
Last Update Posted : October 26, 2006
Merck KGaA, Darmstadt, Germany
Information provided by:
Trial Form Support S.L.

Brief Summary:
The purpose of this study is to determine the 1-year rate of locoregional disease control in the experimental arm, using a control arm to avoid selection bias.

Condition or disease Intervention/treatment Phase
Oropharyngeal Neoplasms Drug: Cetuximab Phase 2

Detailed Description:
  • To determine the 1-year rate of locoregional disease control in the experimental arm, using a control arm to avoid selection bias.
  • To determine the 2 and 3 year rate of locoregional disease control.
  • To evaluate the safety and toxicity of the combination of cetuximab and concomitant-boost accelerated radiotherapy followed by 12 weeks of complementary treatment with cetuximab. Both acute and chronic toxicity will be assessed.
  • To determine specific disease-free survival, event-free survival, disease-specific survival and overall survival
  • To determine acute and late toxicity
  • To determine EGFR, p53, Ki67, and evaluate its value as a prognostic factor.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Randomized Phase II, Multicentre, Pilot Study to Evaluate Safety and Efficacy of the Combination of Cetuximab and Concomitant-Boost Accelerated Radiotherapy Followed or Not by a Complementary Treatment With Cetuximab in Patients With Locally Advanced Oropharynx Squamous Cell Carcinoma.
Study Start Date : November 2005
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Primary Outcome Measures :
  1. 1-year rate of Locoregional Disease Control in the experimental arm, deffined as complete and persistent disappearance of disease in the primary tumour and regional lymph nodes.

Secondary Outcome Measures :
  1. Toxicity and safety of treatment will be evaluated using the Common Toxicity Criteria (CTC) of the NCI, version 3.0.; and late toxicity from radiotherapy, using RTOG/EORTC Late Radiation Morbidity Scoring Scheme.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent.
  • Aged between 18 and 80, inclusive.
  • Karnofsky functional status >= 70% at the time of enrolment in study.
  • Life expectancy of more than 3 months.
  • Histologically confirmed diagnosis of oropharyngeal squamous cell carcinoma: base of tongue, vallecula, tonsil and tonsillar fossa and pillars, glossotonsillar sulcus, inferior surface of the soft palate, uvula and lateral and posterior oropharyngeal wall.
  • Stage III or IV with no evidence of distant metastasis (IVA or IV B)
  • Patients in medical conditions to receive a radical concomitant-boost accelerated radiotherapy treatment.
  • Neutrophils >= 1500/ mm3, platelet count >= 100 000/ mm3 and haemoglobin >= 10 g/ dL.
  • Proper liver function: total bilirubin <= 1.5 x upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN.
  • Proper renal function: serum creatinine <= 1.5 x ULN; if the values are > 1.5 x ULN, creatinine clearance should be >= 55 ml/min.
  • Serum calcium within normal limits.
  • Adequate nutritional state: weight loss < 20% with respect to usual weight and serum albumin > 35 g/l.
  • Effective birth control method if there is possibility of conception and/or pregnancy.
  • Availability of tumour tissue for immunohistochemical analysis of EGFR expression.

Exclusion Criteria:

  • Metastatic disease.
  • Previous surgical, radiotherapy and/or chemotherapy treatment for the disease in the study.
  • Other non-oropharyngeal tumour sites in the head and neck area.
  • Other previous and/or simultaneous squamous cell carcinoma.
  • Diagnosis of any other cancer in the previous 5 years, except properly treated carcinoma in situ of the uterine cervix and/or basal cell skin carcinoma.
  • Active infection (infection requiring intravenous antibiotics), including active tuberculosis and diagnosed HIV.
  • Uncontrolled hypertension defined as systolic blood pressure >= 180 mm Hg and/or diastolic blood pressure >= 130 mm Hg at rest.
  • Pregnancy (absence of pregnancy must be confirmed with the serum-HCG test) or breast-feeding women.
  • Chronic, concomitant systemic immunotherapy, or hormonal treatment for the cancer.
  • Other concomitant anti-cancer treatments.
  • Clinically significant coronary artery disease, history of myocardial infarction in the previous 12 months or high risk of out of control arrhythmia or cardiac insufficiency.
  • Chronic obstructive pulmonary disease which may have required > 3 hospitalisations in the previous 12 months.
  • Out of control active peptic ulcer.
  • Presence of a psychological or medical illness which might impede the patient from carrying out the study or giving his or her signature on the informed consent
  • Known drug abuse (with the exception of excessive alcohol consumption)
  • Known allergic reaction to any of the components of the treatment to be studied.
  • Previous treatment with monoclonal antibodies or signal transduction inhibitors or other EGFR-targeted treatment.
  • Any experimental treatment in the 30 days prior to enrolment in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00251381

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Contact: Jaume Graupera 34 93 185 02 00
Contact: Mar Nicolau 34 93 185 02 00

Show Show 18 study locations
Sponsors and Collaborators
Trial Form Support S.L.
Merck KGaA, Darmstadt, Germany
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Principal Investigator: Ricard Mesia, MD Institut Catala Oncologia: Hospital Durán y Reynals
Principal Investigator: Joaquin Gomez, MD Institut Catala Oncologia: Hospital Durán y Reynals
Layout table for additonal information Identifier: NCT00251381    
Other Study ID Numbers: 62202-655
First Posted: November 10, 2005    Key Record Dates
Last Update Posted: October 26, 2006
Last Verified: October 2006
Keywords provided by Trial Form Support S.L.:
Oropharyngeal Neoplasms
Concomitant-boost accelerated radiotherapy
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents