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

Sponsor

University Hospital, Ghent (Other)

Overall Status

Completed

CT.gov ID

NCT01427010

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Re-irradiation in Recurrent and Second Primary Head and Neck Cancer	Radiation: [18F]FDG-PET-voxel intensity-based IMRT	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Feasibility studyFeasibility study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reirradiation of recurrent and 2nd primary head/neck cancer.	Radiation: [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.

Arm

Intervention/Treatment

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

Radiation: [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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Antwerp University Hospital	Antwerp		Belgium
2	University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator: Wilfried De Neve, Ph.D., M.D., University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT01427010

Other Study ID Numbers:

2011/536

First Posted:

Sep 1, 2011

Last Update Posted:

Apr 19, 2018

Last Verified:

Apr 1, 2018

Additional relevant MeSH terms:

Head and Neck Neoplasms

Recurrence

Study Results

No Results Posted as of Apr 19, 2018