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

PHASE3RecruitingINTERVENTIONAL
Enrollment

308

Participants

Timeline

Start Date

March 4, 2024

Primary Completion Date

March 4, 2028

Study Completion Date

March 4, 2033

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
RADIATION

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.

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.

Trial Locations (11)

SE-803 24

NOT_YET_RECRUITING

Gävle Hospital, Gävle

SE-413 46

NOT_YET_RECRUITING

Sahlgrenska University Hospital, Gothenburg

SE-553 05

NOT_YET_RECRUITING

Jönköping Hospital, Jönköping

Unknown

NOT_YET_RECRUITING

Karlstad Hospital, Karlstad

NOT_YET_RECRUITING

Linköping University hospital, Linköping

RECRUITING

Västmanlands Hospital Västerås, Västerås

SE-221 85

RECRUITING

Lund University Hospital, Lund

SE-703 82

NOT_YET_RECRUITING

Örebro University Hospital, Örebro

SE-171 64

NOT_YET_RECRUITING

Karolinska University Hospital, Stockholm

SE-907 37

RECRUITING

University Hospital, Umeå

SE-753 09

NOT_YET_RECRUITING

Uppsala Accademical Hospital, Uppsala

All Listed Sponsors
lead

Lund University Hospital

OTHER