Simultaneous Integrated Boost (SIB)- IMRT

• Status: Completed
• Trial end date: 2008-05-26
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Collaborator: Centre Georges Francois Leclerc

Criteria

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