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Completed

NCT Number: NCT03376386

Adaptive Dose-Escalated Multi-modality Image-guided 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 radiotherapy scheme. An FDG-PET/CT scan for re-delineation and re-planning will be made at the end of the second and fourth of week of radiotherapy. The non-responding part of the tumor on FDG-PET will receive a mild dose-escalation. Depending on the metabolic response, the entire tumor will receive 70 Gy or the residual FDG-avid area will receive 74 or 78 Gy.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Netherlands Cancer Institute

Amsterdam, 1066CX, Netherlands

About this study

If there is a complete metabolic response on the FDG-PET after 2 weeks, the entire tumor will receive 70 Gy. If there is a complete metabolic response after 4 weeks of treatment, the residual FDG-avid area will receive 74 Gy. If there also is no complete metabolic response after 4 weeks of treatment, the residual FDG-avid area will receive 78 Gy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologic biopsy confirmed squamous cell carcinoma of the oral cavity, HPV-negative oropharynx, HPV-positive oropharynx with a minimum of 10 pack-years, hypopharynx or larynx
  • T2-T4
  • Scheduled for radiotherapy or radiotherapy with cisplatin or cetuximab

Exclusion criteria

  • GFR<30
  • Other neoplasms with metastases in the previous 3 years

Treatment and study plan

Adaptive dose-Escalated multi-modality image-guided radiotherapy

Radiation

FDG-PET/CT-scan will be used twice during radiotherapy for a mild dose-escalation to the less-responding parts of the tumor. By adapting the radiotherapy plan, these areas will receive 74-78 Gy.

Primary outcomes

  1. the feasibility of the adaptive radiotherapy scheme estimated by the acute toxicities and implementation of the adaptive treatment plans

    Time frame: 1 year

    The feasibility of the adaptive radiotherapy schedule will be rejected in case of:

    Occurrence of intolerable radiation-induced acute toxicities.

  2. the feasibility of the adaptive radiotherapy scheme estimated by the implementation of the adaptive treatment plans

    Time frame: 1 year

    The feasibility of the adaptive radiotherapy schedule will be rejected in case of:

    The inability to implement 80% of the adaptive treatment plans within 2 days from the intended starting day

Secondary outcomes

  1. the toxicity of the adaptive RT scheme

    Time frame: 1 year

    according to the CTCAE v4.0 scoring system

  2. the locoregional tumor control

    Time frame: 1 year

  3. relative response will be calculated for the decrease of the SUV-value

    Time frame: 1 year

    the prognostic value of the FDG-PET/CT-scans

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

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

Acronym: ADMIRE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 18, 2017
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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