TPF Plus Radiotherapy and Cetuximab to Avoid Total Laryngectomy in Patients With Larynx Cancer
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
Head and Neck Cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention
Name: TPF, radiotherapy and cetuximab Type: Drug
Name: H&N surgery Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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.
Locations
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Status: Recruiting
Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Status: Recruiting
Hospital de Manresa
Manresa, Barcelona, Spain
Status: Recruiting
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain
Status: Recruiting
Hospital General de Yagüe
Burgos, Spain
Status: Withdrawn
Hospital San Pedro de Alcántara
Cáceres, Spain
Status: Recruiting
Hospital Dr.Josep Trueta (ICO Girona)
Girona, Spain
Status: Recruiting
Hospital Universitario Virgen de las Nieves
Granada, Spain
Status: Recruiting
Oncogranada
Granada, Spain
Status: Terminated
Hospital General Ciudad de Jaén
Jaén, Spain
Status: Withdrawn
Hospital de León
Leon, Spain
Status: Withdrawn
Hospital Xeral Calde
Lugo, Spain
Status: Recruiting
Clínica Quirón
Madrid, Spain
Status: Withdrawn
Hospital Gregorio Marañon
Madrid, Spain
Status: Recruiting
Hospital Universitario 12 de Octubre
Madrid, Spain
Status: Terminated
Hospital Universitario San Carlos
Madrid, Spain
Status: Recruiting
Hospital Son Llátzer
Mallorca, Spain
Status: Recruiting
Hospital General Universitario Morales Meseguer
Murcia, Spain
Status: Withdrawn
Hospital Universitario de Salamanca
Salamanca, Spain
Status: Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Status: Withdrawn
Hospital Clínico de Santiago
Santiago de Compostela, Spain
Status: Withdrawn
Hospital Universitario la Fe de Valencia
Valencia, Spain
Status: Recruiting
Hospital Xeral Cies
Vigo, Spain
Status: Withdrawn
Hospital Clínico Universitario de Zaragoza
Zaragoza, Spain
Status: Recruiting
Hospital Miguel Servet
Zaragoza, Spain
Status: Recruiting
Start Date
October 2008
Completion Date
May 2014
Sponsors
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Source
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page