Status:
RECRUITING
Dose Escalation Using Hypoxia-adjusted Radiotherapy
Lead Sponsor:
Rajiv Gandhi Cancer Institute & Research Center, India
Collaborating Sponsors:
Varian, a Siemens Healthineers Company
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 asse...
Detailed Description
DE-HyART is a randomized, non-blinded study that assesses the effects of combining IMRT (using SIB-Sequential planning) with dose-escalation to hypoxic sub-volume delineated using \[18-F\] FMISO. The ...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
April 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT06087614
Start Date
April 8 2024
End Date
April 1 2028
Last Update
January 17 2025
Active Locations (1)
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1
Rajiv Gandhi Cancer Institute and Research Centre
Delhi, India, 110085