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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-11-30

Brief Summary

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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

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* 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.

Conditions

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Oropharyngeal Neoplasms

Keywords

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Oropharyngeal Neoplasms Cetuximab Concomitant-boost accelerated radiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cetuximab

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Ricard Mesia, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Catala Oncologia: Hospital Durán y Reynals

Joaquin Gomez, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Catala Oncologia: Hospital Durán y Reynals

Reach out to these primary contacts for questions about participation or study logistics.

Jaume Graupera

Role: CONTACT

Phone: 34 93 185 02 00

Email: [email protected]

Mar Nicolau

Role: CONTACT

Phone: 34 93 185 02 00

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

Cetuximab

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Merck KGaA, Darmstadt, Germany

Trial Form Support S.L.

Principal Investigators

Ricard Mesia, MD

Joaquin Gomez, MD

Locations

Hospital Germans Tries i Pujol

H. del Mar / H. de la Esperanza

H. de la Santa Creu I Sant Pau

Institut Catala Oncologia: Hospital Duran y Reynals

Centro Oncológico Regional de Galicia

H. Josep Trueta (ICO)

H. G. Doctor Negrín

Clinica Ruber Internacional

H. Ramón y Cajal

Fundación Jiménez Díaz

H. Gregorio Marañón

Complejo Hospitalario Virgen de la Victoria

H. Carlos Haya

H.U. Virgen de la Arrixaca

Hospital de Navarra

H. U. de Canarias

H. do Meixoeiro

H.U. de Santiago

Countries

Central Contacts

Jaume Graupera

Mar Nicolau

Facility Contacts

Mireia Margelí, MD

Antonio lopez, MD

Manuel Ramos, MD

Victoria Casado, MD

Milva Rodriguez, MD

Other Identifiers

62202-655