Escalating radiation doses for head and neck cancer treatment
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
This study is testing whether giving higher doses of radiation to certain areas of head and neck cancer can help patients with hypoxic tumors do better than with standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Rajiv Gandhi Cancer Institute & Research Center, India Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Delhi) |
| Trial ID | NCT06087614 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial, DE-HyART, investigates the effects of increasing radiation doses specifically targeting hypoxic areas in head and neck squamous cell carcinoma (HNSCC). The study employs intensity-modulated radiation therapy (IMRT) combined with concurrent chemotherapy using cisplatin. Patients will undergo a baseline scan to determine hypoxia levels, and those with hypoxic tumors will be randomized into two treatment arms, one receiving standard treatment and the other receiving an escalated radiation dose. The primary goal is to assess locoregional control and the feasibility of this approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with histologically confirmed squamous cell carcinoma originating from the oral cavity, oropharynx, larynx, or hypopharynx.
Not a fit: Patients with HPV-positive tumors or those who have received prior treatment for head and neck cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve locoregional control rates in patients with hypoxic head and neck tumors.
How similar studies have performed: While similar approaches have been explored, this specific dose escalation strategy targeting hypoxic sub-volumes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Delhi
- Rajiv Gandhi Cancer Institute and Research Centre — Delhi, India (Recruiting)
Study contacts
- Principal investigator: Munish Gairola, MD,DNB Radiation Oncology — Rajiv Gandhi Cancer Institute and Research Centre
- Study coordinator: Sarthak Tandon, DNB
- Email: tandon.sarthak@rgcirc.org
- Phone: +911147022009
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.