Clinical trial NCT00389727: Simultaneous Integrated Boost (SIB)- IMRT
Official title: A Dose Escalation Study With Intensity Modulated Radiation Therapy (IMRT) in Moderately Advanced (T2N0, T2N1, T3N0) Squamous Cell Carcinomas (SCC) of the Oropharynx, Larynx and Hypopharynx Using a Simultaneous Integrated Boost (SIB) Approach.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Squamous Cell
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Centre Georges Francois Leclerc
First posted: 2006-10-19
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

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 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.

Eligibility 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

Primary outcomes:
measure: acute toxicity
timeFrame: during treatment and during the first 3 months following the completion of radiotherapy
Secondary outcomes:
measure: composite endpoint
timeFrame: from ratiotherapy until 2 years after completion of radiotherapy
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
Study officials:
affiliation: Cliniques universitaires Saint Luc Brussels Belgium
name: Vincent Gregoire, MD, PhD
role: STUDY_CHAIR
affiliation: Centre George-François Leclerc Dijon, France
name: Philippe Maingon, MD, PhD
role: STUDY_CHAIR
affiliation: University hospital Gasthuisberg, Katholiek universiteit van Leuven
name: Sandra Nuyts, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Tours, Bretonneau
name: Gilles Calais, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: centre Val d'Aurelle, Montpellier
name: Antoine Serre, MD
role: PRINCIPAL_INVESTIGATOR
References: