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Dose Escalation Using Hypoxia-adjusted Radiotherapy

RECRUITINGPhase 2Sponsored by Rajiv Gandhi Cancer Institute & Research Center, India
Actively Recruiting
PhasePhase 2
SponsorRajiv Gandhi Cancer Institute & Research Center, India
Started2024-04-08
Est. completion2028-04
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06087614

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.

Eligibility

Age: 18 Years – 70 YearsHealthy volunteers accepted
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

Conditions2

CancerHead and Neck Squamous Cell Carcinoma

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