Adaptive Dose-Escalated Multi-modality Image-guided RadiothErapy (ADMIRE) for head and neck cancer by twice re-imaging, re-delineation and re-planning during the course of radiotherapy

Adaptive Dose-Escalated Multi-modality Image-guided RadiothErapy (ADMIRE) for head and neck cancer by twice re-imaging, re-delineation and re-planning during the course of radiotherapy - ADMIRE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47484

Enrollment

Registered

2018-04-12

Start date

2017-12-21

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Head and neck cancer

Interventions

Radiotherapy

Patients with primary head and neck squamous cell carcinoma (HNSCC) planned for treatment with radiotherapy with or without chemotherapy in curative setting will be treated with an adaptive radiothe

Adaptive

Head and neck cancer

Image-guided

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Histologic biopsy confirmed squamous cell carcinoma of the oral cavity, HPV-negative oropharynx, hypopharynx or larynx T2-T4 Scheduled for radiotherapy or radiotherapy with cisplatin or cetuximab

Exclusion criteria

Exclusion criteria: GFR

Design outcomes

Primary

Measure	Time frame
The feasibility of the adaptive radiotherapy schedule will be rejected in case of: - Occurrence of intolerable radiation-induced acute toxicities. - The inability to implement 80% of the adaptive treatment plans within 2 days from the intended starting day (day 13 and day 23 of treatment).	—

Secondary

Measure	Time frame
To examine the toxicity of the adaptive radiotherapy scheme according to the CTCAE v4.0 scoring system The locoregional tumor control The mean value of the different imaging modalities within the tumor will be measured at baseline and during week 2 and 4. Using these, the relative response will be calculated for the following modalities: - FDG-PET: decrease of the SUV-value	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)