At a glance
ClinicalIndex Comparison Record- ✓Age 18-70 years
- ✓Willingness to sign informed consent
- ✓ECOG performance status 0-2
- ✓Histology-proven squamous cell carcinoma
- ✕HPV (p16) positive tumors
- ✕Prior surgery and/or radiation therapy for HNC
- ✕T1/T2 glottis
- ✕Metastatic disease or disease not amenable for definitive locoregional treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating DE-HyART, Standard Arm, and 2 other interventions for Head and Neck Squamous Cell Carcinoma. Currently recruiting, targeting 124 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.
Concurrent chemotherapy, weekly Inj Cisplatin 40mg/m2. This will be given if clinically indicated
Standard institutional practice is detailed before starting the patient. Doses 66-70 Gy over 6-7 weeks