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Clinical Trials/NL-OMON42014
NL-OMON42014
Completed
Phase 2

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) - SN-SPECT for tailoring elective nodal irradiation

Antoni van Leeuwenhoek Ziekenhuis0 sites40 target enrollmentTBD
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ConditionsHead and Neck Cancer10027655

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
Antoni van Leeuwenhoek Ziekenhuis
Enrollment
40
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Antoni van Leeuwenhoek Ziekenhuis

Eligibility Criteria

Inclusion Criteria

  • •\* 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

Exclusion Criteria

  • •\* 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

Outcomes

Primary Outcomes

Not specified

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