A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer

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

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-03-31

Brief Summary

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Treatment adaptation to biological and anatomical changes occurring during treatment can increase the chance of cure at minimized radiation-induced toxicity in head and neck cancer patients. This trial investigates the feasibility of using repetitive per-treatment \[18F\]FDG-PET acquired during treatment in adaptive \[18F\]FDG-PET-voxel intensity-based intensity-modulated radiotherapy (IMRT) or volumetric-modulated arc therapy (VMAT) for head and neck cancer.

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Detailed Description

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Conditions

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Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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repetitive per-treatment [18F]FDG-PET for treatment adaptation

Group Type EXPERIMENTAL

repetitive per-treatment [18F]FDG-PET for treatment adaptation

Intervention Type OTHER

repetitive per-treatment \[18F\]FDG-PET for treatment adaptation

Interventions

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repetitive per-treatment [18F]FDG-PET for treatment adaptation

repetitive per-treatment \[18F\]FDG-PET for treatment adaptation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx.
* Primary unresectable tumor and/or patients refused surgery.
* Stage T1-4; T3-4 N0 or Tany N1-3 for cancer of the glottis.
* Multidisciplinary decision of curative radiotherapy or radiochemotherapy.
* Karnofsky performance status ≥70%.
* Age ≥ 18 years old.
* Informed consent obtained, signed and dated before specific protocol procedures.

Exclusion Criteria

* Treatment combined with brachytherapy.
* Prior irradiation to the head and neck region.
* Distant metastases.
* Second primary tumors that are not under control
* Pregnant or lactating women.
* Creatinine clearance (Cockcroft-Gault) ≤ 60 mL/min before treatment.
* Allergy to the CT-contrast agents.
* Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
* Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No