Testing higher radiation doses to low-oxygen areas in head and neck cancer
Tests higher radiation doses to low-oxygen tumor areas in adults with head and neck cancer.
Plain-language title generated from the registry record
Registry title: Dose Escalation Using Hypoxia-adjusted Radiotherapy
Key facts
- Where
- Delhi, IndiaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06087614, who can take part
Where in India
- Rajiv Gandhi Cancer Institute and Research CentreDelhi, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Rajiv Gandhi Cancer Institute & Research Center, India
- Trial code
- NCT06087614
- Record updated
- 17 January 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Prior surgery and/or radiation therapy given for any HNC; Medical co-morbidity hampering the administration of radiation and/or chemotherapy (cisplatin); Metastatic disease or disease not amenable for definitive locoregional treatment; HPV (p16) positive tumours; T1/T2 Glottis; Pregnancy or lactation.