Simultaneous Integrated Boost (SIB)- IMRT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-24

Study Completion Date

2008-05-26

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

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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.

Conditions

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Carcinoma, Squamous Cell

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 Patients

Radiotherapy Patients

Group Type EXPERIMENTAL

Radiotherapy

Intervention Type DRUG

Radiotherapy

Group 2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Radiotherapy

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No