Simultaneous Integrated Boost (SIB)- IMRT

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.

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

Study Overview

• Status: Completed
• Conditions: Carcinoma, Squamous Cell
• Intervention / Treatment: Drug: 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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 Patients; Radiotherapy Patients	Drug: Radiotherapy; Radiotherapy
No Intervention: Group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute toxicity	acute toxicity	during treatment and during the first 3 months following the completion of radiotherapy

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Collaborators: Centre Georges Francois Leclerc
• Investigators: Study Chair: Vincent Gregoire, MD, PhD, Cliniques universitaires Saint Luc Brussels Belgium; Study Chair: Philippe Maingon, MD, PhD, Centre George-François Leclerc Dijon, France; Principal Investigator: Sandra Nuyts, MD, University hospital Gasthuisberg, Katholiek universiteit van Leuven; Principal Investigator: Gilles Calais, MD, PhD, CHU de Tours, Bretonneau; Principal Investigator: Antoine Serre, MD, centre Val d'Aurelle, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2004
• Primary Completion (Actual): May 26, 2008
• Study Completion (Actual): May 26, 2008

Study Registration Dates

• First Submitted: October 18, 2006
• First Submitted That Met QC Criteria: October 18, 2006
• First Posted (Estimate): October 19, 2006

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: 2004-01avr-074