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Simultaneous Integrated Boost (SIB)- IMRT

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2004 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Centre Georges Francois Leclerc
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00389727
First received: October 18, 2006
Last updated: NA
Last verified: September 2004
History: No changes posted
  Purpose

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


Condition Intervention Phase
Carcinoma, Squamous Cell
Procedure: Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Study Start Date: September 2004
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. Isoeffective relationships based on the Linear-Quadratic (LQ) model have shown that for a similar total physical (nominal) dose, lowering the dose per fraction to below 2 Gy will reduce the biological effect, while increasing the dose per fraction to above 2 Gy will increase that effect [Withers, 1988]. As the highly conformal dose distribution that is achievable with IMRT makes it possible to envisage an increase in physical dose while still maintaining the dose to the OAR at a reasonable level, several options could be considered to attain this objective. In simultaneous accelerated radiation therapy (SMART) boost technique initially described by Butler, large fractions of 2.4 Gy were delivered to the primary Planning Target Volume (PTV) associated with the primary tumor GTV, while conventional fractions of 2 Gy were delivered to the secondary PTV associated with the regions at risk for microscopic disease up to a total dose of 60 Gy and 50 Gy, respectively [Butler, 1999]. The treatment was thus completed in 5 weeks, which corresponded to a moderate shortening of treatment time. The term "simultaneous integrated boost" (SIB) was introduced later to define such treatment, delivering different doses per fraction in different target regions [Mohan, 2000]. The authors proposed either the delivery of the conventional 2 Gy per fraction to the primary PTV, allowing a significantly lower dose per fraction to the secondary PTV, or the delivery of 2 Gy per fraction to the lower and intermediate dose volumes, thereby enabling a higher dose per fraction to be delivered to the primary PTV, with as much as 2.4 Gy for gross disease. The latter regimen has the advantage of shortening the treatment duration which, further increases the biological dose. The SIB technique offers the biological advantage of shortened treatment duration, i.e. 70 Gy over 6 weeks, which has been shown to significantly increase the loco-regional control compared to the same dose delivered in 7 weeks [Fu, 2000]. With the prescription of a dose per fraction of 2.4 Gy to the primary PTV, the physical dose is increased to 72 Gy, which corresponds to a biologically equivalent dose of 79.3 Gy (including correction for the overall treatment time [OTT]). Assuming a 37 value of 2, such an increase in the biological dose of 7.5% could be translated into an increase in loco-regional control in the order of 15% [Bentzen, 2002]. The gain resulting from an increase in the equivalent dose could be achieved without any further increase in late normal tissue complications compared to standard treatment (70 Gy in 2 Gy per fraction). Only the normal tissues embedded in the tumor volume and thus included in the PTV would be irradiated with a dose per fraction similar to that for the tumor itself. Provided that the dose per fraction to the OAR was limited to a maximum of 2 Gy per fraction, this increase in dose intensity would be achievable without undue damage to normal tissue. However, the concept of increased dose intensity with the SIB technique has to be validated in well-designed phase I /II and thereafter phase III trials. In line with this, the Radiation Therapy Oncology Group has initiated an IMRT phase I/II trial (RTOG H-0022) for oropharyngeal carcinomas. In this protocol, a dose of 66 Gy is prescribed for the primary tumor PTV and delivered in 30 fractions of 2.2 Gy over 6 weeks; simultaneously, a physical dose of 54 Gy (30 fractions of 1.8 Gy) is prescribed for the PTV associated with subclinical disease. The main objectives of this protocol are to assess the adequacy of target coverage and salivary gland sparing, to determine the rate and pattern of loco-regional recurrence, and to assess the nature and the prevalence of acute and late normal tissue toxicity and their relationship to the dose distribution. This feasibility study will be carried out to assess clinically the SIB approach in moderately advanced carcinomas.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389727

Contacts
Contact: Vincent Gregoire, MD, PhD +3227644212 vincent.gregoire@imre.ucl.ac.be
Contact: Philippe Maingon, MD, PhD +33380737710 pmaingon@dijon.fnclcc.fr

Locations
Belgium
Cliniques Universitaires Saint Luc Recruiting
Brussels, Belgium, 1200
Contact: Nathalie Delvaux, RN       nathalie.delvaux@clin.ucl.ac.be   
Contact: Liza Nguyen, RN       liza.nguyen-gia@clin.ucl.ac.be   
Principal Investigator: Vincent Gregoire, MD, PhD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00389727     History of Changes
Other Study ID Numbers: 2004-01avr-074
Study First Received: October 18, 2006
Last Updated: October 18, 2006
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on November 20, 2014