Radiotherapy With Cisplatin Versus Radiotherapy With Cetuximab After Induction Chemotherapy for Larynx Preservation

This study has been completed.
Sponsor:
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
First received: September 12, 2005
Last updated: June 23, 2011
Last verified: June 2011
  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 2

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

Resource links provided by NLM:


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
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Centre Oscar Lambret
Lille, France, 59020
Centre René Gauducheau
Nantes, France, 44805
CHU de Tours
Tours, France, 37044
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:
No publications provided by Groupe Oncologie Radiotherapie Tete et Cou

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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:
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

ClinicalTrials.gov processed this record on July 20, 2014