Simultaneous Integrated Boost (SIB)- IMRT

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status and phase

Completed

Phase 2

Conditions

Carcinoma, Squamous Cell

Treatments

Drug: Radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00389727

2004-01avr-074

Details and patient eligibility

About

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

Full 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 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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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