Simultaneous Integrated Boost (SIB)- IMRT

Phase 2

Completed

• Conditions: Carcinoma, Squamous Cell
• Interventions: Drug: Radiotherapy

• Registration Number: NCT00389727
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Timeline

• Study Start: 2004-09-24
• Study First Submitted: 2006-10-18
• Study First Submitted QC: 2006-10-18
• Study First Posted: 2006-10-19
• Primary Completion: 2008-05-26
• Study Completion: 2008-05-26
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-10
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 Patients	Radiotherapy	Radiotherapy Patients

Primary Outcome Measures

Name	Time	Method
acute toxicity	during treatment and during the first 3 months following the completion of radiotherapy	acute toxicity

Secondary Outcome Measures

Name	Time	Method
composite endpoint	from ratiotherapy until 2 years after completion of radiotherapy	composite including loco-regional control, disease-free survival, survival and late toxicity

Trial Locations

Locations (1)

Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Belgium