Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 to 75	Other	GORTEC-TREMPLIN NCT00169247

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Groupe Oncologie Radiotherapie Tete et Cou

Jean-Louis Lefebvre

Principal Investigator

Jean-Louis Lefebvre		Ph: 33 3 20 29 59 54
		Email: jl-lefebvre@o-lambret.fr

France
	Lille
	Centre Oscar Lambret
		Jean-Louis Lefebvre	Ph: 33 3 20 29 59 54
			Email: jl-lefebvre@o-lambret.fr
	Nantes
	Centre Regional Rene Gauducheau
		Frederic Rolland	Ph: 33 2 40 67 99 76
			Email: f-rolland@nantes.fnclcc.fr
	Tours
	Centre Hospitalier Universitaire Bretonneau de Tours
		Gilles Calais	Ph: 33 2 47 47 47 76
			Email: calais@med.univ-tours.fr

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00169247
Information obtained from ClinicalTrials.gov on March 18, 2009