Clinical trial NCT00765011: TPF Plus Radiotherapy and Cetuximab to Avoid Total Laryngectomy in Patients With Larynx Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer
Lead sponsor: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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

Eligibility 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.

Primary outcomes:
measure: Specific survival free of total laryngectomy
timeFrame: Three years after the end of treatment with radiotherapy and cetuximab
Secondary outcomes:
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals
state: Barcelona
city: Manresa
country: Spain
facility: Hospital de Manresa
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Girona
country: Spain
facility: Hospital Dr.Josep Trueta (ICO Girona)
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Granada
country: Spain
facility: Oncogranada
city: Lugo
country: Spain
facility: Hospital Xeral Calde
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario San Carlos
city: Palma De Mallorca
country: Spain
facility: Hospital Son Llátzer
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Valencia
country: Spain
facility: Hospital Universitario la Fe de Valencia
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario de Zaragoza
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Hospital Durán i Reynals
name: Ricard Mesía Nin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital San Carlos, Madrid
name: José A. García Sáenz, MD
role: PRINCIPAL_INVESTIGATOR
References: