Clinical Research Directory
Browse clinical research sites, groups, and studies.
Dose Escalation Using Hypoxia-adjusted Radiotherapy
Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
Summary
DE-HyART is a phase II clinical trial aimed at understanding the effects of escalating radiation doses to hypoxic sub-volumes inherent to squamous cell head and neck cancer. The study is aimed at assessing locoregional control, feasibility, and acceptable toxicity with such a strategy.
Official title: A Phase II Randomised Controlled Study Assessing the Role of Dose Escalation Using [18F] FMISO PET CT in Head and Neck Cancer: The DE-HyART (Dose Escalation Using Hypoxia-adjusted Radiotherapy) Protocol
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2024-04-08
Completion Date
2028-04
Last Updated
2025-01-17
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Cisplatin injection
Concurrent chemotherapy, weekly Inj Cisplatin 40mg/m2. This will be given if clinically indicated
Standard fractionation (Radiation Oncology preference)
Standard institutional practice is detailed before starting the patient. Doses 66-70 Gy over 6-7 weeks
Locations (1)
Rajiv Gandhi Cancer Institute and Research Centre
Delhi, India