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
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.

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

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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

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

Hospital Germans Tries i Pujol Recruiting
Badalona, Barcelona, Spain, 08196
Contact: Mireia Margelí, MD    3493 497 89 25      
Principal Investigator: Mireia Margelí, MD         
Principal Investigator: Antonio Arellano, MD         
Institut Catala Oncologia: Hospital Duran y Reynals Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08097
Principal Investigator: Ricard Mesia, MD         
Principal Investigator: Alicia Lozano, MD         
Centro Oncológico Regional de Galicia Recruiting
A Coruna, Coruña, Spain, 15009
Contact: Manuel Ramos, MD    34 981 287 499      
Principal Investigator: Manuel Ramos, MD         
Principal Investigator: Margarita Martín, MD         
H.U. Virgen de la Arrixaca Recruiting
El Palmar, Murcia, Spain, 30120
Principal Investigator: José L Alonso, MD         
Principal Investigator: Isabel De la Fuente, MD         
Hospital de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Principal Investigator: Ruth Vera, MD         
Principal Investigator: Fernando Arias, MD         
H. U. de Canarias Recruiting
Santa Cruz de Tenerife, Sta Cruz de Tenerife, Spain, 38320
Contact: Milva Rodriguez, MD    34 922 678 746      
Principal Investigator: Milva Rodriguez, MD         
Principal Investigator: Adolfo Vergez, MD         
H. del Mar / H. de la Esperanza Recruiting
Barcelona, Spain, 08003
Principal Investigator: Joan Carles, MD         
Principal Investigator: Palmira Foro, MD         
H. de la Santa Creu I Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Antonio lopez, MD    34 93 291 91 25      
Principal Investigator: Oscar Gallego, MD         
Principal Investigator: Manuel De Vega, MD         
H. Josep Trueta (ICO) Recruiting
Girona, Spain, 17007
Principal Investigator: Jordi Rubio, MD         
Principal Investigator: Jordi Vayreda, MD         
H. G. Doctor Negrín Recruiting
Las Palmas de Gran Canaria, Spain, 35020
Principal Investigator: David Aguiar, MD         
Principal Investigator: Bernardino Clavo, MD         
Clinica Ruber Internacional Recruiting
Madrid, Spain, 28034
Principal Investigator: José E Alés, MD         
Principal Investigator: Rodrigo García, MD         
H. Ramón y Cajal Recruiting
Madrid, Spain, 28034
Principal Investigator: José A Lopez, MD         
Principal Investigator: Asunción Hervás, MD         
Fundación Jiménez Díaz Recruiting
Madrid, Spain, 28040
Contact: Victoria Casado, MD    34 91 550 48 00      
Principal Investigator: Victoria Casado, MD         
Principal Investigator: Ana Pérez, MD         
H. Gregorio Marañón Recruiting
Madrid, Spain, 28040
Principal Investigator: Hector Alburquerque, MD         
Sub-Investigator: Yolanda Escobar, MD         
Complejo Hospitalario Virgen de la Victoria Recruiting
Malaga, Spain, 29010
Principal Investigator: Antonio Rueda, MD         
Principal Investigator: José A Medina, MD         
H. Carlos Haya Recruiting
Malaga, Spain, 29010
Principal Investigator: Ester Villar, Md         
Principal Investigator: Ismael Herruzo, MD         
H.U. de Santiago Recruiting
Santiago, Spain, 15706
Principal Investigator: Rafael Lopez, MD         
Principal Investigator: Mª del Carmen Porto, MD         
H. do Meixoeiro Recruiting
Vigo, Spain, 36200
Principal Investigator: Joaquín Casal, MD         
Principal Investigator: Iñigo Nieto, MD         
Sponsors and Collaborators
Trial Form Support S.L.
Merck KGaA
Principal Investigator: Ricard Mesia, MD Institut Catala Oncologia: Hospital Durán y Reynals
Principal Investigator: Joaquin Gomez, MD Institut Catala Oncologia: Hospital Durán y Reynals Identifier: NCT00251381     History of Changes
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:
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