Dose Escalation Using Hypoxia-adjusted Radiotherapy

PHASE2RecruitingINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

April 8, 2024

Primary Completion Date

April 30, 2028

Study Completion Date

April 30, 2028

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
RADIATION

DE-HyART

The HSV delineation will be done for patients in arm 3 using baseline FMISO. The HSV will be contoured and adjusted according to the second FMISO scan done between the 4th - the 5th week of radiation treatment. A planning CT will also be repeated at the time for adjusting the HSV to account for temporal changes. The Biological Target Volume thus generated after adequate margins will be prescribed 30 Gy in 10 fractions over and above the standard fractination.

RADIATION

Standard Arm

The prescribed radiotherapy dose will be 70 Gy in 2 Gy per fraction daily. The elective volume will be treated with 50 Gy in 2 Gy per fraction daily till the first 5 weeks. The entire treatment will be delivered in a phased mannered using sequential planning.

DRUG

Cisplatin injection

Concurrent chemotherapy, weekly Inj Cisplatin 40mg/m2. This will be given if clinically indicated

RADIATION

Standard fractionation (Radiation Oncology preference)

Standard institutional practice is detailed before starting the patient. Doses 66-70 Gy over 6-7 weeks

Trial Locations (1)

110085

RECRUITING

Rajiv Gandhi Cancer Institute and Research Centre, Delhi

All Listed Sponsors
collaborator

Varian, a Siemens Healthineers Company

INDUSTRY

lead

Rajiv Gandhi Cancer Institute & Research Center, India

OTHER

NCT06087614 - Dose Escalation Using Hypoxia-adjusted Radiotherapy | Biotech Hunter | Biotech Hunter