Adaptive Dose-Escalated Multi-modality Image-guided RadiothErapy

Head and Neck Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376386
• Other study ID #: N17ADM
• Status: Completed
• Phase: N/A
• Start date: December 21, 2017
• Est. completion date: April 25, 2019

Study information

• Verified date: June 2019
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 25, 2019
• Est. primary completion date: April 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

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