Simultaneous Integrated Boost (SIB)- IMRT

Carcinoma, Squamous Cell Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389727
• Other study ID #: 2004-01avr-074
• Status: Completed
• Phase: Phase 2
• Start date: September 24, 2004
• Est. completion date: May 26, 2008

Study information

• Verified date: July 2019
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 26, 2008
• Est. primary completion date: May 26, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell

Intervention

Drug:
• Radiotherapy
Radiotherapy

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Centre Georges Francois Leclerc

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute toxicity	acute toxicity	during treatment and during the first 3 months following the completion of radiotherapy
Secondary	composite endpoint	composite including loco-regional control, disease-free survival, survival and late toxicity	from ratiotherapy until 2 years after completion of radiotherapy