Status:
UNKNOWN
Cetuximab & Concomitant-Boost Accelerated RT in Patients With Locally Advanced Oropharynx Squamous Cell Carcinoma.
Lead Sponsor:
Trial Form Support S.L.
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Oropharyngeal Neoplasms
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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.
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 contro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2009
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00251381
Start Date
November 1 2005
End Date
November 1 2009
Last Update
October 26 2006
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Germans Tries i Pujol
Badalona, Barcelona, Spain, 08196
2
H. del Mar / H. de la Esperanza
Barcelona, Barcelona, Spain, 08003
3
H. de la Santa Creu I Sant Pau
Barcelona, Barcelona, Spain, 08025
4
Institut Catala Oncologia: Hospital Duran y Reynals
L'Hospitalet de Llobregat, Barcelona, Spain, 08097