Radiotherapy With Cisplatin Versus Radiotherapy With Cetuximab After Induction Chemotherapy for Larynx Preservation

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Larynx preservation remains a very challenging approach in patients with larynx/pharynx cancer. A first attempt consisted of induction chemotherapy followed in good responders by irradiation. This approach allowed to preserve 60 % of the larynx without any significant difference in survival. The second attempt consisted of concurrent chemo-irradiation. This approach provided a higher larynx preservation rate but survival remained unchanged and mucosal toxicity was also higher. A third approach is currently under evaluation: induction chemotherapy followed by concurrent chemo-irradiation in good responders.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Oncologie Radiotherapie Tete et Cou
• Collaborators: Groupe d'Etude des Tumeurs de la Tête Et du Cou; Tumor Study Group Head and Neck
• Treatments: Cetuximab; Cisplatin

Criteria

Inclusion Criteria:

• Larynx or hypopharynx squamous cell carcinoma proven by histology, locally advanced, only eligible for surgery as total or sub-total (pharyngo-)laryngectomy

• Performance status 0-1

• Neutrophils >=1.5 x 109/l, Platelets count >=100 x 109/l, haemoglobin >=10 g/dl

• Total bilirubin <= 1.5 x upper reference range

• ASAT and ALAT <= 2.5 x upper reference range, Alkaline Phosphatases <= 5 x upper reference range

• Serum creatinine <= 120 µmol/l

• Weight loss < 10 % within last 3 months

• Written inform consent

Exclusion Criteria:

• Infiltrative transglottic tumor or clinical cartilage invasion

• Distant metastasis

• Previous chemotherapy or radiotherapy

• Contra-indication to chemotherapy