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

Not Applicable

Completed

• Conditions: Re-irradiation in Recurrent and Second Primary Head and Neck Cancer
• Interventions: Radiation: [18F]FDG-PET-voxel intensity-based IMRT

• Registration Number: NCT01427010
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-29
• Study First Submitted QC: 2011-08-31
• Study First Posted: 2011-09-01
• Study Start: 2012-01
• Primary Completion: 2014-08
• Study Completion: 2015-08
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reirradiation of recurrent and 2nd primary head/neck cancer.	[18F]FDG-PET-voxel intensity-based IMRT	-

Primary Outcome Measures

Name	Time	Method
To test success rate of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography ([18F]FDG-PET)-guided radiotherapy (intensity-modulated radiotherapy (IMRT) and/or helical tomotherapy).	2 year	To test feasibility of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography (\[18F\]FDG-PET)-guided radiotherapy (intensity-modulated radiotherapy (IMRT) and/or helical tomotherapy) in treatment of recurrent and second primary head and neck cancer in the previously irradiated territory.

Secondary Outcome Measures

Name	Time	Method
Estimation time to progression.	At 6, 9 and 12 months
Evaluation tumor response.	After 3 months.
Number of Participants with Adverse Events.	Up to 3 months.	Evaluation acute toxicity.

Trial Locations

Locations (2)

Antwerp University Hospital; 🇧🇪 Antwerp, Belgium

University Hospital Ghent; 🇧🇪 Ghent, Belgium