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

Primary Purpose

Oropharyngeal Neoplasms

Status

Unknown status

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Cetuximab

About this trial

This is an interventional treatment trial for Oropharyngeal Neoplasms focused on measuring Oropharyngeal Neoplasms, Cetuximab, Concomitant-boost accelerated radiotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Germans Tries i PujolRecruiting
Institut Catala Oncologia: Hospital Duran y ReynalsRecruiting
Centro Oncológico Regional de GaliciaRecruiting
H.U. Virgen de la ArrixacaRecruiting
Hospital de NavarraRecruiting
H. U. de CanariasRecruiting
H. del Mar / H. de la EsperanzaRecruiting
H. de la Santa Creu I Sant PauRecruiting
H. Josep Trueta (ICO)Recruiting
H. G. Doctor NegrínRecruiting
Clinica Ruber InternacionalRecruiting
H. Ramón y CajalRecruiting
Fundación Jiménez DíazRecruiting
H. Gregorio MarañónRecruiting
Complejo Hospitalario Virgen de la VictoriaRecruiting
H. Carlos HayaRecruiting
H.U. de SantiagoRecruiting
H. do MeixoeiroRecruiting

Outcomes

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.

Full Information

NCT ID

NCT00251381

First Posted

November 9, 2005

Last Updated

October 25, 2006

Sponsor

Trial Form Support S.L.

Collaborators

Merck KGaA, Darmstadt, Germany

1. Study Identification

Unique Protocol Identification Number

NCT00251381

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2006

Overall Recruitment Status

Unknown status

Study Start Date

November 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Trial Form Support S.L.

Collaborators

Merck KGaA, Darmstadt, Germany

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oropharyngeal Neoplasms

Keywords

Oropharyngeal Neoplasms, Cetuximab, Concomitant-boost accelerated radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jaume Graupera

Phone

34 93 185 02 00

jaume.graupera@trialformsupport.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mar Nicolau

Phone

34 93 185 02 00

mar.nicolau@trialformsupport.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ricard Mesia, MD

Organizational Affiliation

Institut Catala Oncologia: Hospital Durán y Reynals

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Joaquin Gomez, MD

Organizational Affiliation

Institut Catala Oncologia: Hospital Durán y Reynals

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Germans Tries i Pujol

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08196

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mireia Margelí, MD

Phone

3493 497 89 25

First Name & Middle Initial & Last Name & Degree

Mireia Margelí, MD

First Name & Middle Initial & Last Name & Degree

Antonio Arellano, MD

Facility Name

Institut Catala Oncologia: Hospital Duran y Reynals

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08097

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ricard Mesia, MD

First Name & Middle Initial & Last Name & Degree

Alicia Lozano, MD

Facility Name

Centro Oncológico Regional de Galicia

City

A Coruna

State/Province

Coruña

ZIP/Postal Code

15009

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Manuel Ramos, MD

Phone

34 981 287 499

First Name & Middle Initial & Last Name & Degree

Manuel Ramos, MD

First Name & Middle Initial & Last Name & Degree

Margarita Martín, MD

Facility Name

H.U. Virgen de la Arrixaca

City

El Palmar

State/Province

Murcia

ZIP/Postal Code

30120

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José L Alonso, MD

First Name & Middle Initial & Last Name & Degree

Isabel De la Fuente, MD

Facility Name

Hospital de Navarra

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ruth Vera, MD

First Name & Middle Initial & Last Name & Degree

Fernando Arias, MD

Facility Name

H. U. de Canarias

City

Santa Cruz de Tenerife

State/Province

Sta Cruz de Tenerife

ZIP/Postal Code

38320

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Milva Rodriguez, MD

Phone

34 922 678 746

First Name & Middle Initial & Last Name & Degree

Milva Rodriguez, MD

First Name & Middle Initial & Last Name & Degree

Adolfo Vergez, MD

Facility Name

H. del Mar / H. de la Esperanza

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joan Carles, MD

First Name & Middle Initial & Last Name & Degree

Palmira Foro, MD

Facility Name

H. de la Santa Creu I Sant Pau

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antonio lopez, MD

Phone

34 93 291 91 25

First Name & Middle Initial & Last Name & Degree

Oscar Gallego, MD

First Name & Middle Initial & Last Name & Degree

Manuel De Vega, MD

Facility Name

H. Josep Trueta (ICO)

City

Girona

ZIP/Postal Code

17007

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jordi Rubio, MD

First Name & Middle Initial & Last Name & Degree

Jordi Vayreda, MD

Facility Name

H. G. Doctor Negrín

City

Las Palmas de Gran Canaria

ZIP/Postal Code

35020

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Aguiar, MD

First Name & Middle Initial & Last Name & Degree

Bernardino Clavo, MD

Facility Name

Clinica Ruber Internacional

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José E Alés, MD

First Name & Middle Initial & Last Name & Degree

Rodrigo García, MD

Facility Name

H. Ramón y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José A Lopez, MD

First Name & Middle Initial & Last Name & Degree

Asunción Hervás, MD

Facility Name

Fundación Jiménez Díaz

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Victoria Casado, MD

Phone

34 91 550 48 00

First Name & Middle Initial & Last Name & Degree

Victoria Casado, MD

First Name & Middle Initial & Last Name & Degree

Ana Pérez, MD

Facility Name

H. Gregorio Marañón

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hector Alburquerque, MD

First Name & Middle Initial & Last Name & Degree

Yolanda Escobar, MD

Facility Name

Complejo Hospitalario Virgen de la Victoria

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antonio Rueda, MD

First Name & Middle Initial & Last Name & Degree

José A Medina, MD

Facility Name

H. Carlos Haya

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ester Villar, Md

First Name & Middle Initial & Last Name & Degree

Ismael Herruzo, MD

Facility Name

H.U. de Santiago

City

Santiago

ZIP/Postal Code

15706

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rafael Lopez, MD

First Name & Middle Initial & Last Name & Degree

Mª del Carmen Porto, MD

Facility Name

H. do Meixoeiro

City

Vigo

ZIP/Postal Code

36200

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joaquín Casal, MD

First Name & Middle Initial & Last Name & Degree

Iñigo Nieto, MD

12. IPD Sharing Statement

Learn more about this trial

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

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