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Sponsors and Collaborators: |
Groupe Oncologie Radiotherapie Tete et Cou Groupe d'Etude des Tumeurs de la Tête Et du Cou |
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Information provided by: | Groupe Oncologie Radiotherapie Tete et Cou |
ClinicalTrials.gov Identifier: | NCT00169247 |
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 |
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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 |
Estimated Enrollment: | 156 |
Study Start Date: | October 2005 |
At ASCO 2004 there were 3 major presentations issuing an increasing in survival:
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jean-Louis Lefebvre | 33 3 20 29 59 54 | jl-lefebvre@o-lambret.fr |
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 |
Principal Investigator: | Jean-Louis Lefebvre | Centre Oscar Lambret |
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 |
larynx cancer hypopharynx cancer larynx preservation concomitant radiochemotherapy |
cisplatin cetuximab randomized trial |
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 |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Radiation-Sensitizing Agents |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |