Mapping of Sentinel lymph node drainage Using SPECT to tailor highly-selective elective nodal irradiation in node-negative neck of patients with head and neck cancer (SUSPECT)
- Conditions
- Head and Neck Cancer10027655
- Registration Number
- NL-OMON42014
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
* Newly diagnosed patients with histopathologic proven primary HNSCC (T1-3N0-2b with maximally 3 involved nodes without extranodal spread) located in the oral cavity, oropharynx, larynx (except T1 glottic), and hypopharynx, not crossing the midline and planned for treatment with (chemo)radiotherapy in curative setting
* No chemotherapy or surgery prior to inclusion
* No distant metastatic spread
* Age * 18 years
* WHO performance status 0 or 1
* Signed written informed consent
* Patients with previously radiation treatment in the head and neck region, for any reason.
* Patients with previous neck dissection.
* Patients with recurrent or second primary tumor in the head and neck region
* Patients with head and neck malignancies arising from skin, lip, nose, sinuses, nasopharynx, salivary glands, thyroid gland or esophagus.
* Previous history of cancer in the last 5 years (excluding basal cell carcinoma of the skin and in situ SCC of the cervix)
* Pregnancy or no active contraception for pre-menopausal women
* Known hypersensitivity to iodine or nanocolloid injection
* Having any condition (physical, mental, sociological) that interferes with the informed consent procedure and follow-up schedules
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Feasibility and safety as well as regional control, toxicity and quality of<br /><br>life of this approach will be investigated</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>