Dose Escalation Using Hypoxia-adjusted Radiotherapy

Recruiting now · Phase 2

Conditions studied: Head and Neck Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT06087614

Run by

Rajiv Gandhi Cancer Institute & Research Center, India

People needed

124

Starts

2024-04-08

Expected to finish

2028-04-01

Last updated by the study team

2025-01-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rajiv Gandhi Cancer Institute and Research Centre — Delhi, India (enrolling)

Full record on ClinicalTrials.gov

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