Clinical trial NCT01427010: A Feasibility Study on Adaptive 18F-FDG-guided Radiotherapy for Recurrent and Second Primary Head and Neck Cancer in the Previously Irradiated Territory.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Re-irradiation in Recurrent and Second Primary Head and Neck Cancer
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2011-09-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: 2 year
Secondary outcomes:
measure: Estimation time to progression.
timeFrame: At 6, 9 and 12 months
measure: Evaluation tumor response.
timeFrame: After 3 months.
measure: Number of Participants with Adverse Events.
timeFrame: Up to 3 months.
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Wilfried De Neve, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References: