Simultaneous Integrated Boost (SIB)- IMRT

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Carcinoma, Squamous Cell

Intervention / Treatment
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* Drug: Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 Patients<br>Radiotherapy Patients | Drug: Radiotherapy<br>* Radiotherapy<br>|
| No Intervention: Group 2<br> | |

What is the study measuring?
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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 |