Adaptive Dose-Escalated Multi-modality Image-guided RadiothErapy

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Radiation: Adaptive dose-Escalated multi-modality image-guided radiotherapy

• Registration Number: NCT03376386
• Lead Sponsor: The Netherlands Cancer Institute

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.

Study Timeline

• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-18
• Study Start: 2017-12-21
• Primary Completion: 2019-04-25
• Study Completion: 2019-04-25
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-26
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HNSCC receiving (chemo)radiotherapy	Adaptive dose-Escalated multi-modality image-guided radiotherapy	Imaging

Primary Outcome Measures

Name	Time	Method
the feasibility of the adaptive radiotherapy scheme estimated by the acute toxicities and implementation of the adaptive treatment plans	1 year	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	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

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

Trial Locations

Locations (1)

Netherlands Cancer Institute; 🇳🇱 Amsterdam, Netherlands