Simultaneous Integrated Boost (SIB)- IMRT

Cliniques universitaires Saint-Luc- Université Catholique de Louvain22 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Squamous Cell

Interventions

RadiotherapyDRUG

Radiotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cliniques Universitaires Saint Luc

Brussels, Belgium

Outcomes

Primary Outcomes

acute toxicity

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

Secondary Outcomes

composite endpoint

composite including loco-regional control, disease-free survival, survival and late toxicity

Time frame: from ratiotherapy until 2 years after completion of radiotherapy

Data from ClinicalTrials.gov

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