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Completed

NCT Number: NCT00389727

Simultaneous Integrated Boost (SIB)- IMRT

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Drug

Radiotherapy

Primary outcomes

  1. acute toxicity

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

    acute toxicity

Secondary outcomes

  1. composite endpoint

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

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

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Collaborators

  • Centre Georges Francois Leclerc

Registry information

Official study 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.

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Oct 19, 2006
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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