Dose Escalation Using Hypoxia-adjusted Radiotherapy

• Status: Recruiting
• Trial end date: 2028-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
• Collaborator: Varian, a Siemens Healthineers Company
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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