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Radiotherapy With Cisplatin Versus Radiotherapy With Cetuximab After Induction Chemotherapy for Larynx Preservation
This study is currently recruiting participants.
Verified by Groupe Oncologie Radiotherapie Tete et Cou, September 2006
Sponsors and Collaborators: Groupe Oncologie Radiotherapie Tete et Cou
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

MedlinePlus related topics: Cancer
Drug Information available for: Docetaxel Cisplatin Fluorouracil Cetuximab
U.S. FDA Resources
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

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

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: GORTEC-TREMPLIN
Study First Received: September 12, 2005
Last Updated: September 23, 2006
ClinicalTrials.gov Identifier: NCT00169247  
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

Study placed in the following topic categories:
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Squamous cell carcinoma
Cetuximab
Pharyngeal Neoplasms
Laryngeal Neoplasms
Pharyngeal Diseases
Carcinoma
Docetaxel
Epidermoid carcinoma
Hypopharyngeal Neoplasms
Cisplatin
Respiratory Tract Diseases
Fluorouracil
Head and Neck Neoplasms
Carcinoma, squamous cell
Laryngeal carcinoma
Hypopharyngeal cancer
Laryngeal Diseases
Stomatognathic Diseases
Carcinoma, Squamous Cell

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009