Status:
COMPLETED
A Feasibility Study on Adaptive 18F-FDG-guided Radiotherapy for Recurrent and Second Primary Head and Neck Cancer in the Previously Irradiated Territory.
Lead Sponsor:
University Hospital, Ghent
Conditions:
Re-irradiation in Recurrent and Second Primary Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01427010
Start Date
January 1 2012
End Date
August 1 2015
Last Update
April 19 2018
Active Locations (2)
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1
Antwerp University Hospital
Antwerp, Belgium
2
University Hospital Ghent
Ghent, Belgium, 9000