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

Phase 2

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: TPF, radiotherapy and cetuximab; Procedure: H&N surgery

• Registration Number: NCT00765011
• Lead Sponsor: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Primary Completion: 2014-02
• Study Completion: 2015-05-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A	TPF, radiotherapy and cetuximab	TPF plus concomitant treatment with cetuximab and conventional radiotherapy
Grupo B	H&N surgery	Surgery

Primary Outcome Measures

Name	Time	Method
Specific survival free of total laryngectomy	Three years after the end of treatment with radiotherapy and cetuximab	Time from the start of TPF treatment to death caused by the disease or by the treatment of the disease, or even to surgery involving total laryngectomy. Deaths caused by other reasons were considered "censored" data on the date of death.

Trial Locations

Locations (17)

Oncogranada; 🇪🇸 Granada, Spain

Hospital Dr.Josep Trueta (ICO Girona); 🇪🇸 Girona, Spain

Hospital Duran i Reynals; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Son Llátzer; 🇪🇸 Palma De Mallorca, Spain

Hospital Clínico Universitario de Zaragoza; 🇪🇸 Zaragoza, Spain

Hospital Universitario la Fe de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Xeral Calde; 🇪🇸 Lugo, Spain

Hospital de Manresa; 🇪🇸 Manresa, Barcelona, Spain

Hospital San Pedro de Alcántara; 🇪🇸 Cáceres, Spain

Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Clínic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Gregorio Marañon; 🇪🇸 Madrid, Spain

Hospital Universitario San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain