Clinical Trial: Radiotherapy With Cisplatin Versus Radiotherapy With Cetuximab After Induction Chemotherapy for Larynx Preservation
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Larynx Preservation With Induction Chemotherapy (Cisplatin, 5FU, Docetaxel) Followed by Radiotherapy Combined With Either Cisplatin or Cetuximab in Laryngopharyngeal Squam
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.
Detailed Summary:
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.
Sponsor: Groupe Oncologie Radiotherapie Tete et Cou
Current Primary Outcome: rate of laryngeal preservation
Original Primary Outcome: Same as current
Current Secondary Outcome: quality of life
Original Secondary Outcome: Same as current
Information By: Groupe Oncologie Radiotherapie Tete et Cou
Dates:
Date Received: September 12, 2005
Date Started: October 2005
Date Completion:
Last Updated: June 23, 2011
Last Verified: June 2011