NCT06087614RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 17 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 18 Sept 2023
- Start date
- 8 Apr 2024
- Primary completion date
- Apr 2028
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, India
- Diseases
- Head and neck cancer
- NCT number
- NCT06087614
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 124
- From 8 Apr 2024 to the primary completion date, Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior surgery and/or radiation therapy given for any HNC
- Medical co-morbidity hampering the administration of radiation and/or chemotherapy (cisplatin)
Other illness
- Metastatic disease or disease not amenable for definitive locoregional treatment.
Other
- HPV (p16) positive tumours
- T1/T2 Glottis
- Pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rajiv Gandhi Cancer Institute and Research Centre Coordinator of this site? Confirm its status | Delhi | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.