Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169247
Status:
COMPLETED
Last Update Posted:
2011-06-27
First Post:
2005-09-12
Brief Title:
Radiotherapy With Cisplatin Versus Radiotherapy With Cetuximab After Induction Chemotherapy for Larynx Preservation
Sponsor:
Groupe Oncologie Radiotherapie Tete et Cou
Organization:
Groupe Oncologie Radiotherapie Tete et Cou
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Larynx preservation remains a very challenging approach in patients with larynxpharynx 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 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 TPFT 75 mgm² P 75 mgm² and 5FU 750 mgm²
Patients with response over 50 endoscopy and CTscan will be randomized to receive either irradiation 70 Gy and cisplatinum 100 mgm² 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
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 TPFT 75 mgm² P 75 mgm² and 5FU 750 mgm²
Patients with response over 50 endoscopy and CTscan will be randomized to receive either irradiation 70 Gy and cisplatinum 100 mgm² 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None