Clinical trial NCT06087614: Dose Escalation Using Hypoxia-adjusted Radiotherapy
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
Conditions: Head and Neck Squamous Cell Carcinoma
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.
Interventions:
description: 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.
name: DE-HyART
other_name: Dose escalated radiotherapy
FMISO
Hypoxic sub volume
type: Radiation
description: 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.
name: Standard Arm
other_name: Standard Sequential fractionation without dose escalation
type: Radiation
description: Concurrent chemotherapy, weekly Inj Cisplatin 40mg/m2. This will be given if clinically indicated
name: Cisplatin injection
type: Drug
description: Standard institutional practice is detailed before starting the patient. Doses 66-70 Gy over 6-7 weeks
name: Standard fractionation (Radiation Oncology preference)
type: Radiation
Study arms:
design_group_description: The radiation dose will be similar to 'arm 2'. In addition, the HSV identified on baseline FMISO scans will be contoured, and an isotropic margin of 5 mm will be given. This volume will be boosted in phase II to a total dose of 80 Gy. (Addition of 30 Gy in 3 Gy daily fraction added in phase II as a simultaneous integrated boost - SIB).
design_group_title: Arm 3 - DE-HyART
design_group_type: Experimental
design_group_description: 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.
design_group_title: Arm 2 - Hypoxic Comparator Arm
design_group_type: Active Comparator
design_group_description: The patients will be treated with a standard of care where the treatment will not be controlled, and these patients will act as external control representing clinical practice. However, these patients will be discussed in the head and neck multispeciality clinic and follow the institutional approach. They will be subjected to treatment similar to 'arm 2' but are allowed protocol deviation as per treating radiation oncology discretion.
design_group_title: Arm 1 - Non-hypoxic arm
design_group_type: Placebo Comparator
Sponsor: Rajiv Gandhi Cancer Institute & Research Center
Collaborators: Varian Ltd.
Drug name mappings:
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP