TPF Plus Radiotherapy and Cetuximab to Avoid Total Laryngectomy in Patients With Larynx Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
ClinicalTrials.gov Identifier:
NCT00765011
First received: October 1, 2008
Last updated: February 12, 2011
Last verified: February 2011
  Purpose

A Phase II Trial With Radiotherapy Plus Cetuximab to Evaluate Specific Survival Free of Laryngectomy in Patients With Resectable and Locally Advanced Larynx Cancer, After Treatment With TPF Chemotherapy.


Condition Intervention Phase
Head and Neck Cancer
Drug: TPF, radiotherapy and cetuximab
Procedure: H&N surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II Trial With Radiotherapy Plus Cetuximab to Evaluate Specific Survival Free of Laryngectomy in Patients With Resectable and Locally Advanced Larynx Cancer, After Treatment With TPF

Resource links provided by NLM:


Further study details as provided by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello:

Primary Outcome Measures:
  • Specific survival [ Time Frame: Three years after the end of treatment with radiotherapy and cetuximab ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 92
Study Start Date: October 2008
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
TPF plus concomitant treatment with cetuximab and conventional radiotherapy
Drug: TPF, radiotherapy and cetuximab
3 cycles of: cisplatin: 75mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracilo: 750 mg/m2, i.v., 24 hours, 5 days Radiotherapy: 70Gy,divided into daily doses of 2 Gray (total days:35) Cetuximab: 400 mg/m2, i.v, 2 hours, 1 day Cetuximab: 250 mg/m2, i.v, 1 hour, 7 days
Other Name: TPF plus radiotherapy and cetuximab
Grupo B
Surgery
Procedure: H&N surgery
Rescue surgery
Other Name: Rescue surgery

Detailed Description:

This study is being sponsored by a cooperative medical group.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed Informed Consent Form.
  2. Men or women, age (18 and 70).
  3. ECOG scale:0-1.
  4. Life expectancy superior to 3 months.
  5. Larynx squamous carcinoma histologically demonstrated.
  6. Patients with larynx squamous carcinoma, stage III-IVA, with resectable disease whose surgery will imply a total laryngectomy. The T should be a T3, T4A, or a T2 not candidate for a partial laryngectomy. In case of T2 of any of both locations it will be required a III or IVA stadium.
  7. Patients to be able to receive treatment with TPF followed by normofractionated radiotherapy with cetuximab.
  8. Measurable disease (OMS criteria).
  9. Neutrophils superior or equal to 1500/mm3, platelets superior or equal to 150.000/mm3, hemoglobin superior or equal to 10 g/dl.
  10. Adequate renal function: creatinin lower or equal to 120 µmol/l (1,4mg/dl)
  11. Adequate hepatic function: bilirubin lower or equal to 1 x UNL, AST and ALT lower or equal to 2,5 UNL, alkaline phosphatase lower or equal to 5 UNL.
  12. Seric calcium adjusted to albumine lower or equal to 1,25 UNL.
  13. Adequate nutritional condition: loss of weight <20% with relation to the theoretical weight and albumin superior or equal to 35 g/L.
  14. Use of an effective contraceptive method.

Exclusion Criteria:

  1. Metastatic disease
  2. Surgical treatment, previous radiotherapy and/or chemotherapy for the study disease.
  3. Other tumour locations in H&N that are not larynx.
  4. Other stages that are not III or IVa without metastasis and resectable disease.
  5. The following cases, which will be considered candidates for radical surgery, will not be included in the study:

    • Tumors of the subglottis.
    • Tumors of glottis or supraglottis with subglottal extension
    • Tumor that destroys the thyroid cartilage and/or cricoid and it extends to thyroid gland or soft necks's tissues.
    • Tumor of supraglottis with a superior extension to 1 cm towards the tongue base (the extension will be measured since the vallecula).
  6. Other previous and/or synchronic squamous carcinoma.
  7. Diagnosis of another neoplasia in the last 5 years, excepting carcinoma in situ of uterine neck and/or a cutaneous carcinoma basocellular properly treated.
  8. Active infection(at needs endovenous antibiotics), including active tuberculosis and diagnosed HIV.
  9. Not controlled hypertension defined as arterial systolic tension superior or equal to 180 mm Hg and/or diastolic arterial tension superior or equal to 130 mm Hg baseline.
  10. Pregnancy or breastfeeding.
  11. Immunity systemic treatment, chronic and concomitant, or hormonal treatment of the cancer.
  12. Other antineoplasic concomitant treatments.
  13. Coronary clinically significant arteriopathy or precedents of myocardial infarction in the last 12 months or high risk of not controlled arrhythmia or cardiac not controlled insufficiency.
  14. Pulmonary obstructive chronic disease that had needed 3 or more hospitalizations in the last 12 months.
  15. Active non controlled peptic ulcer.
  16. Presence of a psychological or medical disease that could prevent to accomplish the study by the patient or to grant his/her signature in the informed consent form.
  17. Known drugs abuse (excepting excessive consumption of alcohol).
  18. Known allergic reaction to some of the components of the treatment of the study.
  19. Previous treatment with monoclonal antibodies or other transduction of the sign inhibitors or treatment directed against the EGFR.
  20. Any experimental treatment in 30 days before entry in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765011

Contacts
Contact: Juan C Adansa, MD +34 923 29 11 00 ext 749 unidad_eecc@usal.es

Locations
Spain
Hospital Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Principal Investigator: Beatriz Cirauqui, MD         
Hospital Duran i Reynals Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Principal Investigator: Ricard Mesia, MD         
Hospital de Manresa Recruiting
Manresa, Barcelona, Spain
Principal Investigator: Esther Casado, MD         
Hospital Clínic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Principal Investigator: Juan J Grau, MD         
Hospital General de Yagüe Withdrawn
Burgos, Spain
Hospital San Pedro de Alcántara Recruiting
Cáceres, Spain
Principal Investigator: Mª Angeles Rodríguez, MD         
Hospital Dr.Josep Trueta (ICO Girona) Recruiting
Girona, Spain, 17007
Principal Investigator: José Rubio, MD         
Oncogranada Terminated
Granada, Spain
Hospital Universitario Virgen de las Nieves Recruiting
Granada, Spain
Principal Investigator: Antonio L Irigoyen, MD         
Hospital General Ciudad de Jaén Withdrawn
Jaén, Spain
Hospital de León Withdrawn
Leon, Spain
Hospital Xeral Calde Recruiting
Lugo, Spain
Principal Investigator: José R Mel, MD         
Hospital Universitario San Carlos Recruiting
Madrid, Spain
Principal Investigator: José A García, MD         
Hospital Universitario 12 de Octubre Terminated
Madrid, Spain
Clínica Quirón Withdrawn
Madrid, Spain
Hospital Gregorio Marañon Recruiting
Madrid, Spain
Principal Investigator: Yolanda escobar, MD         
Hospital Son Llátzer Recruiting
Mallorca, Spain
Principal Investigator: Mª Belén González, MD         
Hospital General Universitario Morales Meseguer Withdrawn
Murcia, Spain
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain
Sub-Investigator: Juan J Cruz, MD         
Principal Investigator: Elvira del Barco Morillo, MD         
Sub-Investigator: Juan Carlos Adansa Klain, MD         
Hospital Universitario Marqués de Valdecilla Withdrawn
Santander, Spain
Hospital Clínico de Santiago Withdrawn
Santiago de Compostela, Spain
Hospital Universitario la Fe de Valencia Recruiting
Valencia, Spain
Principal Investigator: Miguel Pastor, MD         
Hospital Xeral Cies Withdrawn
Vigo, Spain
Hospital Clínico Universitario de Zaragoza Recruiting
Zaragoza, Spain
Principal Investigator: Julio Lambea, MD         
Hospital Miguel Servet Recruiting
Zaragoza, Spain
Principal Investigator: Javier Martínez Trufero, MD         
Sponsors and Collaborators
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Investigators
Principal Investigator: Ricard Mesía Nin, MD Hospital Durán i Reynals
Principal Investigator: José A. García Sáenz, MD Hospital Clínico San Carlos
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Juan Jesús Cruz, Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
ClinicalTrials.gov Identifier: NCT00765011     History of Changes
Other Study ID Numbers: TTCC-2007-02
Study First Received: October 1, 2008
Last Updated: February 12, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello:
Head and Neck Cancer

Additional relevant MeSH terms:
Laryngeal Neoplasms
Head and Neck Neoplasms
Otorhinolaryngologic Neoplasms
Neoplasms by Site
Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014