Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389727
Status:
COMPLETED
Last Update Posted:
2019-07-15
First Post:
2006-10-18
Brief Title:
Simultaneous Integrated Boost SIB- IMRT
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Overview
Official Title:
A Dose Escalation Study With Intensity Modulated Radiation Therapy IMRT in Moderately Advanced T2N0 T2N1 T3N0 Squamous Cell Carcinomas SCC of the Oropharynx Larynx and Hypopharynx Using a Simultaneous Integrated Boost SIB Approach
Status:
COMPLETED
Status Verified Date:
2019-07
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:
The objective of the study is to assess the feasibility of increasing dose of irradiation with IMRT using a SIB approach over 6 weeks
The primary endpoint of the study will be acute toxicity assessed during treatment and during the first 3 months following the completion of radiotherapy The secondary endpoint will include loco-regional control disease-free survival survival and late toxicity at 2 years after completion of radiotherapy
The primary endpoint of the study will be acute toxicity assessed during treatment and during the first 3 months following the completion of radiotherapy The secondary endpoint will include loco-regional control disease-free survival survival and late toxicity at 2 years after completion of radiotherapy
Detailed Description:
Loco-regional failures remain a major concern following irradiation of locally advanced head and neck cancers This has led radiation oncologists to investigate novel approaches offering better therapeutic indexes Modification of dose fractionation schedules can improve the therapeutic outcome by using accelerated or hyperfractionated regimes -Ang 1990 Ang 1998 Fu 2000 Gwozdz 1997- Intensity Modulated Radiation Therapy IMRT technique allows the planning and irradiation of different targets at different dose levels in a single treatment session instead of successive treatment plans With conventional 2D radiotherapy both normal tissues and tumors are irradiated with a similar dose per fraction of 18-2 Gy whereas with IMRT dose gradients are introduced in such a manner that normal tissues receive a much lower dose per fraction
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