CompletedPhase 2

Simultaneous Integrated Boost (SIB)- IMRT

Belgium22 participantsStarted 2004-09-24

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

acute toxicity

Timeframe: during treatment and during the first 3 months following the completion of radiotherapy

Trial details

NCT IDNCT00389727

SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-05-26

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