NCT03376386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

December 21, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2019

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

September 26, 2017

Last Update Submit

June 26, 2019

Conditions

Head and Neck Cancer

Keywords

AdaptiveImage-guidedRadiotherapyHead and Neck cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • the toxicity of the adaptive RT scheme

    1 year

  • the locoregional tumor control

    1 year

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

    1 year

Study Arms (1)

HNSCC receiving (chemo)radiotherapy

OTHER

Imaging

Radiation: Adaptive dose-Escalated multi-modality image-guided radiotherapy

Interventions

Adaptive dose-Escalated multi-modality image-guided radiotherapyRADIATION

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.

HNSCC receiving (chemo)radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, 1066CX, Netherlands

Location

Related Publications (2)

  • Al-Mamgani A, Kessels R, Gouw ZAR, Navran A, Mohan V, van de Kamer JB, Sonke JJ, Vogel WV. Adaptive FDG-PET/CT guided dose escalation in head and neck squamous cell carcinoma: Late toxicity and oncologic outcomes (The ADMIRE study). Clin Transl Radiat Oncol. 2023 Sep 17;43:100676. doi: 10.1016/j.ctro.2023.100676. eCollection 2023 Nov.

    PMID: 37753461DERIVED

  • 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.

    PMID: 32361007DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Abrahim Al-Mamgani, MD, PhD

    The Netherlands Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Feasibility study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2017

First Posted

December 18, 2017

Study Start

December 21, 2017

Primary Completion

April 25, 2019

Study Completion

April 25, 2019

Last Updated

June 27, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)