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Oropharyngeal NeoplasmsPhase 2NCT00251381

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

A Phase 2 study testing Cetuximab in people with Oropharyngeal Neoplasms, run by Trial Form Support S.L. at 18 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Oropharyngeal Neoplasms
What is being tested?
Cetuximab
How many people
90 participants
Where
18 sitesSpain
Study dates
Nov 2005to Nov 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

18 sites in 1 country.

Jaume Graupera contact

34 93 185 02 00

jaume.graupera@trialformsupport.com

Mar Nicolau contact

34 93 185 02 00

mar.nicolau@trialformsupport.com

18 sites in 1 country

Spain18 sites, 18 recruiting

  • Centro Oncológico Regional de Galicia

    A Coruña, Coruña, 15009

    Manuel Ramos, MD, 34 981 287 499

    Manuel Ramos, MD

    Recruiting

  • Hospital Germans Tries i Pujol

    Badalona, Barcelona, 08196

    Mireia Margelí, MD, 3493 497 89 25

    Mireia Margelí, MD

    Recruiting

  • H. del Mar / H. de la Esperanza

    Barcelona, Barcelona, 08003

    Joan Carles, MD

    Palmira Foro, MD

    Recruiting

  • H. de la Santa Creu I Sant Pau

    Barcelona, Barcelona, 08025

    Antonio lopez, MD, 34 93 291 91 25

    Oscar Gallego, MD

    Recruiting

  • H.U. Virgen de la Arrixaca

    El Palmar, Murcia, 30120

    José L Alonso, MD

    Isabel De la Fuente, MD

    Recruiting

  • H. Josep Trueta (ICO)

    Girona, Girona, 17007

    Jordi Rubio, MD

    Jordi Vayreda, MD

    Recruiting

  • Institut Catala Oncologia: Hospital Duran y Reynals

    L'Hospitalet de Llobregat, Barcelona, 08097

    Ricard Mesia, MD

    Alicia Lozano, MD

    Recruiting

  • H. G. Doctor Negrín

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

    David Aguiar, MD

    Bernardino Clavo, MD

    Recruiting

  • Clinica Ruber Internacional

    Madrid, Madrid, 28034

    José E Alés, MD

    Rodrigo García, MD

    Recruiting

  • H. Ramón y Cajal

    Madrid, Madrid, 28034

    José A Lopez, MD

    Asunción Hervás, MD

    Recruiting

  • Fundación Jiménez Díaz

    Madrid, Madrid, 28040

    Victoria Casado, MD, 34 91 550 48 00

    Victoria Casado, MD

    Recruiting

  • H. Gregorio Marañón

    Madrid, Madrid, 28040

    Hector Alburquerque, MD

    Yolanda Escobar, MD

    Recruiting

  • Complejo Hospitalario Virgen de la Victoria

    Málaga, Malaga, 29010

    Antonio Rueda, MD

    José A Medina, MD

    Recruiting

  • H. Carlos Haya

    Málaga, Malaga, 29010

    Ester Villar, Md

    Ismael Herruzo, MD

    Recruiting

  • Hospital de Navarra

    Pamplona, Navarre, 31008

    Ruth Vera, MD

    Fernando Arias, MD

    Recruiting

  • H. U. de Canarias

    Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38320

    Milva Rodriguez, MD, 34 922 678 746

    Milva Rodriguez, MD

    Recruiting

  • H.U. de Santiago

    Santiago, 15706

    Rafael Lopez, MD

    Mª del Carmen Porto, MD

    Recruiting

  • H. do Meixoeiro

    Vigo, Vigo, 36200

    Joaquín Casal, MD

    Iñigo Nieto, MD

    Recruiting

Other trials in Spain

About this study

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.

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.

Read the 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.
Being tested
Cetuximab
Keywords
Oropharyngeal Neoplasms, Cetuximab, Concomitant-boost accelerated radiotherapy
Medical subject headings
Oropharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2005 (estimated)
  2. Study startNov 2005
  3. Study completionNov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00251381
Sponsor's protocol ID
62202-655
Status last verified
Oct 2006
First submitted
9 Nov 2005
Last updated
26 Oct 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab in people with Oropharyngeal Neoplasms, run by Trial Form Support S.L. at 18 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jaume Graupera (34 93 185 02 00, jaume.graupera@trialformsupport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00251381.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2006.

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