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Brief Title: Simultaneous Integrated Boost (SIB)- IMRT
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.
Study ID: NCT00389727
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
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 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cliniques Universitaires Saint Luc, Brussels, , Belgium
Name: Vincent Gregoire, MD, PhD
Affiliation: Cliniques universitaires Saint Luc Brussels Belgium
Role: STUDY_CHAIR
Name: Philippe Maingon, MD, PhD
Affiliation: Centre George-François Leclerc Dijon, France
Role: STUDY_CHAIR
Name: Sandra Nuyts, MD
Affiliation: University hospital Gasthuisberg, Katholiek universiteit van Leuven
Role: PRINCIPAL_INVESTIGATOR
Name: Gilles Calais, MD, PhD
Affiliation: CHU de Tours, Bretonneau
Role: PRINCIPAL_INVESTIGATOR
Name: Antoine Serre, MD
Affiliation: centre Val d'Aurelle, Montpellier
Role: PRINCIPAL_INVESTIGATOR