A Feasibility Study on Adaptive 18F-FDG-guided Radiotherapy for Recurrent and Second Primary Head and Neck Cancer in the Previously Irradiated Territory.

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

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-08-31

Brief Summary

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Adaptive dose painting appears to increase the chance of cure at minimized radiation-induced toxicity in intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This could also be of importance in IMRT for recurrent and second primary head and neck cancers in previously irradiated territory.

This trial investigates the feasibility of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography-voxel (\[18F\]FDG-PET-voxel) intensity-based IMRT in reirradiation of patients with recurrent and second primary head and neck cancer.

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Detailed Description

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Conditions

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Re-irradiation in Recurrent and Second Primary Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Feasibility study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reirradiation of recurrent and 2nd primary head/neck cancer.

Group Type EXPERIMENTAL

[18F]FDG-PET-voxel intensity-based IMRT

Intervention Type RADIATION

Non-controlled, non-randomized, prospective study on 18F-Fluorodeoxyglucose-Positron Emission Tomography (\[18F\]FDG-PET)-voxel intensity-based intensity-modulated radiotherapy (IMRT) (dose painting) adapted to the anatomical and biological changes as detected by per-treatment FDG-PET/Computertomography (CT) acquired at the end of the 2nd and the 4th week of treatment.

Interventions

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[18F]FDG-PET-voxel intensity-based IMRT

Non-controlled, non-randomized, prospective study on 18F-Fluorodeoxyglucose-Positron Emission Tomography (\[18F\]FDG-PET)-voxel intensity-based intensity-modulated radiotherapy (IMRT) (dose painting) adapted to the anatomical and biological changes as detected by per-treatment FDG-PET/Computertomography (CT) acquired at the end of the 2nd and the 4th week of treatment.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed recurrences and second primary squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx in the previously irradiated territory.
* Primary unresectable tumor and/or patients refused surgery.
* No grade 3 or more late toxicity (except xerostomia) after the initial radio(chemo)therapy for primary head and neck cancer.
* Minimal interval 12 months after the initial radio(chemo)therapy for primary head and neck cancer.
* Decision of a multidisciplinary tumor board on curative radiotherapy (in combination or not with targeted therapy with cetuximab)
* Karnofsky performance status ≥70%.
* Age ≥ 18 years old.
* Informed consent obtained, signed and dated before specific protocol procedures.

Exclusion Criteria

* Previous radiotherapy for cT1-2 cN0 M0 glottic cancer.
* Brachytherapy as treatment for second primary / recurrence.
* Distant metastases.
* Other second primary tumors that are not under control.
* Pregnant or lactating women.
* Elevated blood creatinine level.
* 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