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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Adaptive dose-Escalated multi-modality image-guided radiotherapy
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Adaptive, Image-guided, Radiotherapy, Head and Neck cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Netherlands Cancer Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

HNSCC receiving (chemo)radiotherapy

Arm Description

Imaging

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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

Full Information

First Posted
September 26, 2017
Last Updated
June 26, 2019
Sponsor
The Netherlands Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03376386
Brief Title
Adaptive Dose-Escalated Multi-modality Image-guided RadiothErapy
Acronym
ADMIRE
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
December 21, 2017 (Actual)
Primary Completion Date
April 25, 2019 (Actual)
Study Completion Date
April 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Adaptive, Image-guided, Radiotherapy, Head and Neck cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HNSCC receiving (chemo)radiotherapy
Arm Type
Other
Arm Description
Imaging
Intervention Type
Radiation
Intervention Name(s)
Adaptive dose-Escalated multi-modality image-guided radiotherapy
Intervention Description
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 Outcome Measure Information:
Title
the feasibility of the adaptive radiotherapy scheme estimated by the acute toxicities and implementation of the adaptive treatment plans
Description
The feasibility of the adaptive radiotherapy schedule will be rejected in case of: Occurrence of intolerable radiation-induced acute toxicities.
Time Frame
1 year
Title
the feasibility of the adaptive radiotherapy scheme estimated by the implementation of the adaptive treatment plans
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
the toxicity of the adaptive RT scheme
Description
according to the CTCAE v4.0 scoring system
Time Frame
1 year
Title
the locoregional tumor control
Time Frame
1 year
Title
relative response will be calculated for the decrease of the SUV-value
Description
the prognostic value of the FDG-PET/CT-scans
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abrahim Al-Mamgani, MD, PhD
Organizational Affiliation
The Netherlands Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Netherlands Cancer Institute
City
Amsterdam
ZIP/Postal Code
1066CX
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32361007
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.
Results Reference
derived

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Adaptive Dose-Escalated Multi-modality Image-guided RadiothErapy

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