Simultaneous Integrated Boost (SIB)- IMRT
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.
1 other identifier
interventional
22
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2004
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 24, 2004
CompletedFirst Submitted
Initial submission to the registry
October 18, 2006
CompletedFirst Posted
Study publicly available on registry
October 19, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2008
CompletedJuly 15, 2019
July 1, 2019
3.7 years
October 18, 2006
July 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
acute toxicity
acute toxicity
during treatment and during the first 3 months following the completion of radiotherapy
Secondary Outcomes (1)
composite endpoint
from ratiotherapy until 2 years after completion of radiotherapy
Study Arms (2)
Group 1 Patients
EXPERIMENTALRadiotherapy Patients
Group 2
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2006
First Posted
October 19, 2006
Study Start
September 24, 2004
Primary Completion
May 26, 2008
Study Completion
May 26, 2008
Last Updated
July 15, 2019
Record last verified: 2019-07