Clinical trial NCT03376386: Adaptive Dose-Escalated Multi-modality Image-guided RadiothErapy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Adaptive
Image-guided
Radiotherapy
Head and Neck cancer
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: the feasibility of the adaptive radiotherapy scheme estimated by the acute toxicities and implementation of the adaptive treatment plans
timeFrame: 1 year
measure: the feasibility of the adaptive radiotherapy scheme estimated by the implementation of the adaptive treatment plans
timeFrame: 1 year
Secondary outcomes:
measure: the toxicity of the adaptive RT scheme
timeFrame: 1 year
measure: the locoregional tumor control
timeFrame: 1 year
measure: relative response will be calculated for the decrease of the SUV-value
timeFrame: 1 year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
Study officials:
affiliation: The Netherlands Cancer Institute
name: Abrahim Al-Mamgani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gouw ZAR, La Fontaine MD, Vogel WV, van de Kamer JB, Sonke JJ, Al-Mamgani A. Single-Center Prospective Trial Investigating the Feasibility of Serial FDG-PET Guided Adaptive Radiation Therapy for Head and Neck Cancer. Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):960-968. doi: 10.1016/j.ijrobp.2020.04.030. Epub 2020 Apr 30.