Adaptive Dose-Escalated Multi-modality Image-guided RadiothErapy (ADMIRE)

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Radiation: Adaptive dose-Escalated multi-modality image-guided radiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1066CX
    • Netherlands Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: HNSCC receiving (chemo)radiotherapy; Imaging	Radiation: Adaptive dose-Escalated multi-modality image-guided radiotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the feasibility of the adaptive radiotherapy scheme estimated by the acute toxicities and implementation of the adaptive treatment plans	The feasibility of the adaptive radiotherapy schedule will be rejected in case of: Occurrence of intolerable radiation-induced acute toxicities.	1 year
the feasibility of the adaptive radiotherapy scheme estimated by the implementation of the adaptive treatment plans	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the toxicity of the adaptive RT scheme	according to the CTCAE v4.0 scoring system	1 year
the locoregional tumor control		1 year
relative response will be calculated for the decrease of the SUV-value	the prognostic value of the FDG-PET/CT-scans	1 year

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Investigators: Principal Investigator: Abrahim Al-Mamgani, MD, PhD, The Netherlands Cancer Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2017
• Primary Completion (Actual): April 25, 2019
• Study Completion (Actual): April 25, 2019

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): June 27, 2019
• Last Update Submitted That Met QC Criteria: June 26, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Radiotherapy; Adaptive; Head and Neck cancer; Image-guided
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: N17ADM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No