NCT00251381

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2005

Typical duration for phase_2

Geographic Reach
1 country

18 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2005

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

October 26, 2006

Status Verified

October 1, 2006

First QC Date

November 9, 2005

Last Update Submit

October 25, 2006

Conditions

Oropharyngeal Neoplasms

Keywords

Oropharyngeal NeoplasmsCetuximabConcomitant-boost accelerated radiotherapy

Outcome Measures

Primary Outcomes (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 Outcomes (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.

Interventions

CetuximabDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Hospital Germans Tries i Pujol

Badalona, Barcelona, 08196, Spain

RECRUITING

H. del Mar / H. de la Esperanza

Barcelona, Barcelona, 08003, Spain

RECRUITING

H. de la Santa Creu I Sant Pau

Barcelona, Barcelona, 08025, Spain

RECRUITING

Institut Catala Oncologia: Hospital Duran y Reynals

L'Hospitalet de Llobregat, Barcelona, 08097, Spain

RECRUITING

Centro Oncológico Regional de Galicia

A Coruña, Coruña, 15009, Spain

RECRUITING

H. Josep Trueta (ICO)

Girona, Girona, 17007, Spain

RECRUITING

H. G. Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35020, Spain

RECRUITING

Clinica Ruber Internacional

Madrid, Madrid, 28034, Spain

RECRUITING

H. Ramón y Cajal

Madrid, Madrid, 28034, Spain

RECRUITING

Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

RECRUITING

H. Gregorio Marañón

Madrid, Madrid, 28040, Spain

RECRUITING

Complejo Hospitalario Virgen de la Victoria

Málaga, Malaga, 29010, Spain

RECRUITING

H. Carlos Haya

Málaga, Malaga, 29010, Spain

RECRUITING

H.U. Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

RECRUITING

Hospital de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

H. U. de Canarias

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38320, Spain

RECRUITING

H. do Meixoeiro

Vigo, Vigo, 36200, Spain

RECRUITING

H.U. de Santiago

Santiago, 15706, Spain

RECRUITING

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Ricard Mesia, MD

    Institut Catala Oncologia: Hospital Durán y Reynals

    PRINCIPAL INVESTIGATOR

  • Joaquin Gomez, MD

    Institut Catala Oncologia: Hospital Durán y Reynals

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaume Graupera

CONTACT

34 93 185 02 00jaume.graupera@trialformsupport.com

Mar Nicolau

CONTACT

34 93 185 02 00mar.nicolau@trialformsupport.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2005

First Posted

November 10, 2005

Study Start

November 1, 2005

Study Completion

November 1, 2009

Last Updated

October 26, 2006

Record last verified: 2006-10

Locations

ES(18)