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Spots Global Cancer Trial Database for Simultaneous Integrated Boost (SIB)- IMRT

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Trial Identification

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

Interventions

Radiotherapy

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Cliniques Universitaires Saint Luc, Brussels, , Belgium

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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