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Clinical Trial 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


Clinical Trial 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 1.8-2 Gy, whereas with IMRT dose gradients are introduced in such a manner that normal tissues receive a much lower dose per fraction. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00389727
Study type Interventional
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact
Status Completed
Phase Phase 2
Start date September 24, 2004
Completion date May 26, 2008

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