Reduction of complications for head and neck cancer: Individual lymph node irradiation (iNode)

Reduction of complications for head and neck cancer: Individual lymph node irradiation (iNode) - iNode

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51653

Enrollment

Registered

2022-06-22

Start date

2023-10-16

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck cancer / tumor

Interventions

In this study individual lymph nodes will be irradiated with the full elective dose, the lymph node levels possibly containing small invisible lymph nodes will be irradiated with a lower dose. In th

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Squamous cell carcinoma of the larynx, oropharynx or hypopharynx - T2 -T4 stage - N0-1, based on bilateral ultrasound / MRI / PET of the neck - Indication for curative primary (accelerated) RT - Indication for bilateral ENI

Exclusion criteria

Exclusion criteria: - Concurrent chemotherapy or cetuximab - Patients unsuited for MRI imaging - Synchronous malignant tumor(s) at another site - Previous malignancies in the HN region treated with surgery, chemotherapy or radiotherapy, except for tumors treated with endoscopic glottic laser microsurgery. - Previous dissection of LNs in the neck - A history of malignant disease for which treatment was ended = 2 - Distant metastasis - Participation into another interventional study - Mental or physical impairment causing the participant to be unable to fill out questionnaires

Design outcomes

Primary

Measure	Time frame
The percentage of fractions successfully performed on the MR-Linac. Either inadequate patient tolerability or planning/contouring issues could lead to missing fractions.	—

Secondary

Measure	Time frame
Regarding patient safety: • Regional recurrence occurring inside the elective neck volumes • MR-related hearing impairment, measured in the first weeks after RT treatment Regarding RT toxicity: • Quality of life scoring: EORTC Quality of Life Questionnaire (QLQ-C30) and the EORTC Quality of Life Questionnaire HNC cancer (QLQ-HN35). Patients will be invited to fill out questionnaires at baseline and 3, 6, 12 and 24 months after treatment. • Common Terminology Criteria for Adverse Events (CTCAE) will be filled in by the radiation oncologist before the start of RT and 3, 6, 12 and 24 months after treatment. Regarding patient tolerability: • Patient reported outcomes (PROs) regarding tolerability of treatment on the MR-linac will be measured with the previously validated MRL patient reported experience questionnaire of the PERCEIVE study (METC-protocol number: 20-624/C) on three time points: after the first, the 10th and the last fraction.	—

Measure

Time frame

Regarding patient safety: • Regional recurrence occurring inside the elective neck volumes • MR-related hearing impairment, measured in the first weeks after RT treatment Regarding RT toxicity: • Quality of life scoring: EORTC Quality of Life Questionnaire (QLQ-C30) and the EORTC Quality of Life Questionnaire HNC cancer (QLQ-HN35). Patients will be invited to fill out questionnaires at baseline and 3, 6, 12 and 24 months after treatment. • Common Terminology Criteria for Adverse Events (CTCAE) will be filled in by the radiation oncologist before the start of RT and 3, 6, 12 and 24 months after treatment. Regarding patient tolerability: • Patient reported outcomes (PROs) regarding tolerability of treatment on the MR-linac will be measured with the previously validated MRL patient reported experience questionnaire of the PERCEIVE study (METC-protocol number: 20-624/C) on three time points: after the first, the 10th and the last fraction.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 21, 2026