Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158678
Status:
COMPLETED
Last Update Posted:
2020-04-15
First Post:
2005-09-09
Brief Title:
IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC
Sponsor:
Groupe Oncologie Radiotherapie Tete et Cou
Organization:
Groupe Oncologie Radiotherapie Tete et Cou
Study Overview
Official Title:
Phase III Trial of Intensity-modulated Radiotherapy Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2020-04
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:
This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy 75 Gy plus cisplatin versus conventional radiotherapy 70 Gy plus cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity oropharynx or hypopharynx The main end points are the rate of locoregional control and the rate of xerostomia at 2 years
Detailed Description:
This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy plus concomitant cisplatin versus conventional radiotherapy plus concomitant cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity oropharynx or hypopharynx The main end points are the rate of locoregional control and the rate of xerostomia at 2 years
The IMRT total dose is 75 Gy 50 Gy to PTV1 and T0 25 Gy 10 fractions to PTV2 The conventional radiotherapy total dose is 70 Gy 50 Gy to PTV1 20 Gy 10 fractions to PTV2 In both arms the cervical nodes will receive 50 Gy 65 Gy in case of Np by conventional radiotherapy IMRT is allowed in the IRMT arm In the two arms patients will receive concomitant cisplatin 100 mgm² D1 D21 D42
The IMRT total dose is 75 Gy 50 Gy to PTV1 and T0 25 Gy 10 fractions to PTV2 The conventional radiotherapy total dose is 70 Gy 50 Gy to PTV1 20 Gy 10 fractions to PTV2 In both arms the cervical nodes will receive 50 Gy 65 Gy in case of Np by conventional radiotherapy IMRT is allowed in the IRMT arm In the two arms patients will receive concomitant cisplatin 100 mgm² D1 D21 D42
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