Radiotherapy With Cisplatin Versus Radiotherapy With Cetuximab After Induction Chemotherapy for Larynx Preservation - Full Text View

Sponsor:	Groupe Oncologie Radiotherapie Tete et Cou
Collaborator:	Groupe d'Etude des Tumeurs de la Tête Et du Cou
Information provided by:	Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:	NCT00169247

Purpose

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.

Condition	Intervention	Phase
Larynx Cancer Hypopharynx Cancer	Drug: cetuximab Drug: Cisplatin Procedure: Radiotherapy 70 Gy, 35 fractions	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin Cetuximab

U.S. FDA Resources

Further study details as provided by Groupe Oncologie Radiotherapie Tete et Cou:

Primary Outcome Measures:

rate of laryngeal preservation

Secondary Outcome Measures:

quality of life

Estimated Enrollment:	156
Study Start Date:	October 2005

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169247

Contacts

Contact: Jean-Louis Lefebvre

33 3 20 29 59 54

jl-lefebvre@o-lambret.fr

Locations

France
Centre Oscar Lambret	Recruiting
Lille, France, 59020
Contact: Jean-Louis Lefebvre 33 3 20 29 59 54 jl-lefebvre@o-lambret.fr
CHU de Tours	Recruiting
Tours, France, 37044
Contact: Gilles Calais 33 2 47 47 47 76 calais@med.univ-tours.fr
Centre René Gauducheau	Recruiting
Nantes, France, 44805
Contact: Frederic Rolland 33 2 40 67 99 76 f-rolland@nantes.fnclcc.fr

Sponsors and Collaborators

Groupe Oncologie Radiotherapie Tete et Cou

Groupe d'Etude des Tumeurs de la Tête Et du Cou

Investigators

Principal Investigator:

Jean-Louis Lefebvre

Centre Oscar Lambret

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	GORTEC-TREMPLIN
Study First Received:	September 12, 2005
Last Updated:	September 23, 2006
ClinicalTrials.gov Identifier:	NCT00169247 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:

larynx cancer
hypopharynx cancer
larynx preservation
concomitant radiochemotherapy

cisplatin
cetuximab
randomized trial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Cetuximab
Pharyngeal Neoplasms
Laryngeal Neoplasms
Pharyngeal Diseases
Pharmacologic Actions

Hypopharyngeal Neoplasms
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Respiratory Tract Diseases
Therapeutic Uses
Head and Neck Neoplasms
Laryngeal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on February 08, 2010