Simultaneous Integrated Boost (SIB)- IMRT
July 10, 2019 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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.
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
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brussels, Belgium, 1200
- Cliniques Universitaires Saint Luc
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients older than 18 years
- Patients with squamous cell carcinoma of the oropharynx, hypopharynx and larynx
- Stage T2-N0-M0, T2-N1-M0 or T3-N0-M0
- World Health Organization (WHO) Performance Status of 0 or 1 or Karnofsky performance status ≥ 70.
- Provision of written informed consent
Exclusion Criteria:
- Second primary tumor at the time of diagnosis
- Previous history of malignant tumor in the last five years except basal cell carcinoma and carcinoma in situ of the cervix
- Previous treatment with surgery, radiotherapy or chemotherapy for head and neck malignancy
- Any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease), or psychological disorder
- Pregnant or lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1 Patients
Radiotherapy Patients
|
Radiotherapy
|
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No Intervention: Group 2
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
acute toxicity
Time Frame: during treatment and during the first 3 months following the completion of radiotherapy
|
acute toxicity
|
during treatment and during the first 3 months following the completion of radiotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
composite endpoint
Time Frame: from ratiotherapy until 2 years after completion of radiotherapy
|
composite including loco-regional control, disease-free survival, survival and late toxicity
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from ratiotherapy until 2 years after completion of radiotherapy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Vincent Gregoire, MD, PhD, Cliniques universitaires Saint Luc Brussels Belgium
- Study Chair: Philippe Maingon, MD, PhD, Centre George-François Leclerc Dijon, France
- Principal Investigator: Sandra Nuyts, MD, University hospital Gasthuisberg, Katholiek universiteit van Leuven
- Principal Investigator: Gilles Calais, MD, PhD, CHU de Tours, Bretonneau
- Principal Investigator: Antoine Serre, MD, centre Val d'Aurelle, Montpellier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 24, 2004
Primary Completion (Actual)
May 26, 2008
Study Completion (Actual)
May 26, 2008
Study Registration Dates
First Submitted
October 18, 2006
First Submitted That Met QC Criteria
October 18, 2006
First Posted (Estimate)
October 19, 2006
Study Record Updates
Last Update Posted (Actual)
July 15, 2019
Last Update Submitted That Met QC Criteria
July 10, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004-01avr-074
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.