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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2006 by Trial Form Support S.L..
Recruitment status was:  Recruiting
Merck KGaA
Information provided by:
Trial Form Support S.L. Identifier:
First received: November 9, 2005
Last updated: October 25, 2006
Last verified: October 2006
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 Intervention Phase
Oropharyngeal Neoplasms
Drug: Cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by Trial Form Support S.L.:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 90
Study Start Date: November 2005
Estimated Study Completion Date: November 2009
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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00251381

Hospital Germans Tries i Pujol
Badalona, Barcelona, Spain, 08196
Institut Catala Oncologia: Hospital Duran y Reynals
Hospitalet de Llobregat, Barcelona, Spain, 08097
Centro Oncológico Regional de Galicia
A Coruna, Coruña, Spain, 15009
H.U. Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Hospital de Navarra
Pamplona, Navarra, Spain, 31008
H. U. de Canarias
Santa Cruz de Tenerife, Sta Cruz de Tenerife, Spain, 38320
H. del Mar / H. de la Esperanza
Barcelona, Spain, 08003
H. de la Santa Creu I Sant Pau
Barcelona, Spain, 08025
H. Josep Trueta (ICO)
Girona, Spain, 17007
H. G. Doctor Negrín
Las Palmas de Gran Canaria, Spain, 35020
Clinica Ruber Internacional
Madrid, Spain, 28034
H. Ramón y Cajal
Madrid, Spain, 28034
Fundación Jiménez Díaz
Madrid, Spain, 28040
H. Gregorio Marañón
Madrid, Spain, 28040
Complejo Hospitalario Virgen de la Victoria
Malaga, Spain, 29010
H. Carlos Haya
Malaga, Spain, 29010
H.U. de Santiago
Santiago, Spain, 15706
H. do Meixoeiro
Vigo, Spain, 36200
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
  More Information Identifier: NCT00251381     History of Changes
Other Study ID Numbers: 62202-655 
Study First Received: November 9, 2005
Last Updated: October 25, 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 processed this record on February 20, 2017