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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello.
Recruitment status was:  Recruiting
Information provided by:
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello Identifier:
First received: October 1, 2008
Last updated: February 12, 2011
Last verified: February 2011
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
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 ]

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
Procedure: H&N surgery
Rescue surgery
Other Name: Rescue surgery

Detailed Description:
This study is being sponsored by a cooperative medical group.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00765011

Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de Manresa
Manresa, Barcelona, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital San Pedro de Alcántara
Cáceres, Spain
Hospital Dr.Josep Trueta (ICO Girona)
Girona, Spain, 17007
Hospital Universitario Virgen de las Nieves
Granada, Spain
Granada, Spain
Hospital Xeral Calde
Lugo, Spain
Hospital Gregorio Marañon
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario San Carlos
Madrid, Spain
Hospital Son Llátzer
Mallorca, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario la Fe de Valencia
Valencia, Spain
Hospital Clínico Universitario de Zaragoza
Zaragoza, Spain
Hospital Miguel Servet
Zaragoza, Spain
Sponsors and Collaborators
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
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:
Responsible Party: Prof. Juan Jesús Cruz, Grupo Español de Tratamiento de Tumores de Cabeza y Cuello Identifier: NCT00765011     History of Changes
Other Study ID Numbers: TTCC-2007-02 
Study First Received: October 1, 2008
Last Updated: February 12, 2011

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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Laryngeal Neoplasms
Neoplasms by Site
Otorhinolaryngologic Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Antineoplastic Agents processed this record on February 20, 2017