Dose Escalation Using Hypoxia-adjusted Radiotherapy
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
Rajiv Gandhi Cancer Institute & Research Center, India
124 participants
Apr 8, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria12
- Age: 18 - 70 years
- Willingness to sign informed consent (written/video documentation)
- Performance status: ECOG 0 - 2
- Histology proved - squamous cell carcinoma
- Any grade, gender
- Tumour sites: Oral Cavity, Oropharynx, Hypopharynx and Larynx
- Sufficient bone marrow reserve within the last 14 days.
- Hb: \> 10g/dl (corrected)
- TLC: \> 4,000 per cumm
- Platelet: \>1.5Lakh per cumm
- Liver functions and kidney functions within normal limits
- Nutritional and dental assessment before inclusion into the study
Exclusion Criteria6
- HPV (p16) positive tumours
- Prior surgery and/or radiation therapy given for any HNC
- T1/T2 Glottis
- Metastatic disease or disease not amenable for definitive locoregional treatment.
- Medical co-morbidity hampering the administration of radiation and/or chemotherapy (cisplatin)
- Pregnancy or lactation
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
Locations(1)
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NCT06087614