Active — Not RecruitingNot Applicable

Lymph Drainage Mapping for Tailoring Elective Nodal Irradiation in Head and Neck Cancer

Netherlands90 participantsStarted 2019-07-22

Plain-language summary

This study aims to explore the safety and outcome of lymph drainage mapping(LDM) to individually tailor the elective nodal irradiation (ENI) to the ipsilateral neck only. The goal is to exclude the contralateral negative neck from the irradiation fields when there is no contralateral draining sentinel node. In case contralateral lymph drainage is found on SPECT/CT, a contralateral sentinel node procedure (SNP) is performed to remove the draining node. The patient will only receive contralateral ENI if (micro/macro)metastasis are found in this contralateral sentinel node.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Newly diagnosed and histopathologically proven primary HNSCC * T1-4N0-2b * Tumor does not cross midline * WHO performance status 0 or 1 * Signed written informed consent Exclusion Criteria: * Distant metastatic spread at the time of inclusion * Chemotherapy or surgery (for the present tumor), prior to inclusion * Previous radiation treatment in the head and neck region, for any reason * Previous neck dissection * Recurrent or second primary tumor in the head and neck region * Head and neck malignancies arising from skin, lip, nose, sinuses, nasopharynx, salivary glands, thyroid gland or esophagus * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Contralateral regional failure

Timeframe: 1 year

Trial details

NCT IDNCT03968679

SponsorThe Netherlands Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-14

View on ClinicalTrials.gov More Head and Neck Cancer trials