Status:
COMPLETED
Simultaneous Integrated Boost (SIB)- IMRT
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborating Sponsors:
Centre Georges Francois Leclerc
Conditions:
Carcinoma, Squamous Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 assesse...
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 therap...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 24 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2008
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00389727
Start Date
September 24 2004
End Date
May 26 2008
Last Update
July 15 2019
Active Locations (1)
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1
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200