Status:
COMPLETED
Radiotherapy With Cisplatin Versus Radiotherapy With Cetuximab After Induction Chemotherapy for Larynx Preservation
Lead Sponsor:
Groupe Oncologie Radiotherapie Tete et Cou
Collaborating Sponsors:
Tumor Study Group Head and Neck
Conditions:
Larynx Cancer
Hypopharynx Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 app...
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 signif...
Eligibility Criteria
Inclusion
- 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
- Infiltrative transglottic tumor or clinical cartilage invasion
- Distant metastasis
- Previous chemotherapy or radiotherapy
- Contra-indication to chemotherapy
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00169247
Start Date
October 1 2005
Last Update
June 27 2011
Active Locations (3)
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1
Centre Oscar Lambret
Lille, France, 59020
2
Centre René Gauducheau
Nantes, France, 44805
3
CHU de Tours
Tours, France, 37044