a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-04

Study Completion Date

2033-03-04

Brief Summary

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There is an unmet need to personalise treatment for patients with head and neck squamous cell carcinoma (HNSCC) and to improve treatment results for patients with advanced disease. In this phase III study, HNSCC patients with prognostic factors indicating increased risk of treatment failure that are aimed for curative treatment with radiotherapy (RT) will be randomised between standard treatment (conventionally fractionated RT with final RT dose 68.0 Gy) and hyperfractionated RT (HFX-RT) with final RT dose 83.0 Gy.

In order to find better prognostic and predictive tools the study also includes exploratory and translational analyses including evaluation of grade of hypoxia with Magnetic Resonance Imaging (MRI) and gene profiling by RNA-sequencing, tumour immune profiling, comparisons of global gene expression, gene aberrations and protein expression, and texture analyses of CT, FDG-PET and MRI images used during RT preparation and during patient follow-up. Patients with tumours with lower risk of recurrence, not eligible for randomisation in the study, can still participate in the translational parts of the study not investigating response to altered fractionation.

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Detailed Description

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Conditions

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Head and Neck Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventionally fractioned (standard) group

This groups is treated with standard radiotherapy treatment: RT 2.0 Gy daily to final radiation dose 68.0 Gy or

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type RADIATION

68.0 Gy in 34 fractions, 2.00 Gy per fraction per day, five or six days per week to tumour volumes and 54.4 Gy in 34 fractions, 1.60 Gy per fraction to elective neck nodes.

HFX-RT group

Treated with Hyperfractionated radiotherapy (HFX-RT): Gy twice daily (10 fractions/week) with final dose 83.0 Gy

Group Type EXPERIMENTAL

Hyperfractionated radiotherpy

Intervention Type RADIATION

83.0 Gy in 68 fractions, 1.22 Gy per fraction, two daily fractions, five days per week to the primary tumour volume (GTVT\_83.0). To the primary tumour with an added margin (PTVT\_74.8) and to neck node metastases (PTVN\_74.8) the prescribed dose will be 74.8 Gy in 68 fractions, 1.10 Gy per fraction twice daily. To elective neck nodes (PTV 54.4) the prescribed dose will be 54.4 Gy in 68 fractions, 0.80 Gy per fraction twice daily.

Interventions

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Hyperfractionated radiotherpy

83.0 Gy in 68 fractions, 1.22 Gy per fraction, two daily fractions, five days per week to the primary tumour volume (GTVT\_83.0). To the primary tumour with an added margin (PTVT\_74.8) and to neck node metastases (PTVN\_74.8) the prescribed dose will be 74.8 Gy in 68 fractions, 1.10 Gy per fraction twice daily. To elective neck nodes (PTV 54.4) the prescribed dose will be 54.4 Gy in 68 fractions, 0.80 Gy per fraction twice daily.

Intervention Type RADIATION

Control group

68.0 Gy in 34 fractions, 2.00 Gy per fraction per day, five or six days per week to tumour volumes and 54.4 Gy in 34 fractions, 1.60 Gy per fraction to elective neck nodes.

Intervention Type RADIATION

Other Intervention Names

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HFX-RT standard treatment

Eligibility Criteria

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Inclusion Criteria

1. The patient must be at least 18 years old.
2. Histologically or cytologically confirmed, previously untreated, HNSCC of the oropharynx, hypopharynx, larynx or oral cavity without distant metastases and aimed for treatment with radiotherapy (with or without concomitant chemotherapy) with curative intent.
3. The primary tumour must fulfil the following high-risk criteria:

1. For p16+ oropharyngeal cancer: Radiographic measurement of threeorthogonal diameters must render a tumour estimate of ≥30 cc.
2. For all other subsites and for p16- oropharyngeal cancer: Radiographic measurement of three orthogonal diameters must render a tumour estimate of ≥20 cc.
4. The treatment may be followed but not preceded by surgery, either as a salvage procedure or a neck dissection. An excision of a lymph node or tonsillectomy for diagnostic purposes, does not exclude the patient from participation.
5. WHO/ECOG performance status 0-2
6. The patient must be able to understand the information about the treatment and give a written informed consent to participate in the trial.

Exclusion Criteria

1. Previous radiotherapy in the head and neck region.
2. Concomitant or previous malignancies, except uncomplicated basal cell carcinoma, early (T1-2 N0) squamous cell carcinoma of the skin with follow-up time of at least one year for squamous cell carcinomas, and except other cancer with a disease-free follow-up of at least three years
3. Two or more synchronous primary HNSCC at time of diagnosis
4. Nasopharyngeal cancer
5. Sinonasal cancer
6. Co-existing disease prejudicing survival (expected survival \< three years).
7. Pregnancy or lactation
8. Psychiatric or addictive disorders or other medical conditions which in the view of the investigator might impair patient compliance

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No