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

Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Procedure: H&N surgery; Drug: TPF, radiotherapy and cetuximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00765011

TTCC-2007-02

Details and patient eligibility

About

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.

Full description

This study is being sponsored by a cooperative medical group.

Enrollment: 94 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Group A

Experimental group

Description:

TPF plus concomitant treatment with cetuximab and conventional radiotherapy

Treatment:

Drug: TPF, radiotherapy and cetuximab

Grupo B

Other group

Description:

Surgery

Treatment:

Procedure: H&N surgery