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

Larynx Cancer Clinical Trial

Official title:

Larynx Preservation With Induction Chemotherapy (Cisplatin, 5FU, Docetaxel) Followed by Radiotherapy Combined With Either Cisplatin or Cetuximab in Laryngopharyngeal Squamous Cell Carcinoma - A Randomised Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169247
• Other study ID #: GORTEC-TREMPLIN
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: June 23, 2011
• Start date: October 2005

Study information

• Verified date: June 2011
• Source: Groupe Oncologie Radiotherapie Tete et Cou
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

At ASCO 2004 there were 3 major presentations issuing an increasing in survival:

• the update of the MACH-NC meta-analysis showed that actually only concurrent chemo-irradiation trials found a significantly improved survival (in particular the addition of cisplatinum alone to radiotherapy)

• the addition of docetaxel to the cisplatinum-5FU regimen (TPF) when compared with cisplatinum--5FU (PF)

• the addition of cetuximab to irradiation

On this basis we decided to carry-out a randomized phase II for previously untreated patients requiring a total laryngectomy:

All patients after a complete work-up including a CTscan will receive 3 cycles of TPF(T: 75 mg/m², P: 75 mg/m² and 5FU 750 mg/m²).

Patients with response over 50 % (endoscopy and CTscan) will be randomized to receive either irradiation (70 Gy) and cisplatinum (100 mg/m² on D1, D22 and D43) or irradiation (70 Gy) with cetuximab (loading dose of 400 mg followed by weekly 250 mg for a total of 8 cycles.

Patients with less than 50% decease in tumour volume after TPF, patients with residual or recurrent disease after either RT-CDDP or RT-cetuximab will get salvage total laryngectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypopharyngeal Neoplasms
• Hypopharynx Cancer
• Laryngeal Diseases
• Larynx Cancer

Intervention

Drug:
• cetuximab

• Cisplatin

Procedure:
• Radiotherapy 70 Gy, 35 fractions

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille
France	Centre René Gauducheau	Nantes
France	CHU de Tours	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Oncologie Radiotherapie Tete et Cou	Groupe d'Etude des Tumeurs de la Tête Et du Cou

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of laryngeal preservation
Secondary	quality of life

External Links

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