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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00389727

Enrollment

Registered

2006-10-19

Start date

2004-09-24

Completion date

2008-05-26

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Squamous Cell

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.

Interventions

DRUGRadiotherapy

Radiotherapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026