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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00169247
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : June 27, 2011
Sponsor:
Collaborator:
Tumor Study Group Head and Neck
Information provided by:
Groupe Oncologie Radiotherapie Tete et Cou

Study Description
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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 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 or disease Intervention/treatment Phase
Larynx Cancer Hypopharynx Cancer Drug: cetuximab Drug: Cisplatin Procedure: Radiotherapy 70 Gy, 35 fractions Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2005
Actual Primary Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. rate of laryngeal preservation

Secondary Outcome Measures :
  1. quality of life

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169247


Locations
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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
Tumor Study Group Head and Neck
Investigators
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Principal Investigator: Jean-Louis Lefebvre Centre Oscar Lambret
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00169247    
Other Study ID Numbers: GORTEC-TREMPLIN
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011
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:
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Laryngeal Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
 Neoplasms by Site
Neoplasms
Respiratory Tract Neoplasms
Cetuximab
Antineoplastic Agents
Antineoplastic Agents, Immunological