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

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ClinicalTrials.gov Identifier: NCT03376386
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):

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 and MRI 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.

Condition or disease Intervention/treatment
Head and Neck Cancer 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Feasibility study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 21, 2017
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
HNSCC receiving (chemo)radiotherapy
Imaging
Radiation: Adaptive dose-Escalated multi-modality image-guided radiotherapy
FDG-PET/CT 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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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

  4. relative response will be calculated for the increase of the ADC-value [ Time Frame: 1 year ]
    the prognostic value of the DWI-MRI

  5. relative response will be calculated for the decrease of the Ktrans-value [ Time Frame: 1 year ]
    the prognostic value of the DCE-MRI


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376386


Contacts
Contact: Abrahim Al-Mamgani, MD, PhD 003120 ‐ 512 9111 a.almamgani@nki.nl
Contact: Zeno AR Gouw, MD 003120 ‐ 512 9111 z.gouw@nki.nl

Locations
Netherlands
Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands, 1066CX
Contact: Abrahim Al-Mamgani, MD, PhD    +31 20 512 9111    a.almamgani@nki.nl   
Contact: Zeno Gouw, MD    +31 20 512 9111    z.gouw@nki.nl   
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
Principal Investigator: Abrahim Al-Mamgani, MD, PhD The Netherlands Cancer Institute
More Information

Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT03376386     History of Changes
Other Study ID Numbers: N17ADM
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Netherlands Cancer Institute:
Adaptive
Image-guided
Radiotherapy
Head and Neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms