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| 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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France | |
| Centre Oscar Lambret | |
| Lille, France, 59020 | |
| Centre René Gauducheau | |
| Nantes, France, 44805 | |
| CHU de Tours | |
| Tours, France, 37044 | |
| Principal Investigator: | Jean-Louis Lefebvre | Centre Oscar Lambret |
More Information
| ClinicalTrials.gov Identifier: | NCT00169247 History of Changes |
| Other Study ID Numbers: | GORTEC-TREMPLIN |
| Study First Received: | September 12, 2005 |
| Last Updated: | June 23, 2011 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
larynx cancer hypopharynx cancer larynx preservation concomitant radiochemotherapy |
cisplatin cetuximab randomized trial |
|
Laryngeal Neoplasms Carcinoma, Squamous Cell Laryngeal Diseases Hypopharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Otorhinolaryngologic Diseases Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms, Squamous Cell Pharyngeal Neoplasms Pharyngeal Diseases Stomatognathic Diseases Cetuximab Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
