Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT06087614

Dose Escalation Using Hypoxia-adjusted Radiotherapy

Led by Rajiv Gandhi Cancer Institute & Research Center, India · Updated on 2025-01-17

124

Participants Needed

1

Research Sites

207 weeks

Total Duration

On this page

Sponsors

R

Rajiv Gandhi Cancer Institute & Research Center, India

Lead Sponsor

V

Varian, a Siemens Healthineers Company

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Dose Escalation Using Hypoxia-adjusted Radiotherapy

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years
  • Willingness to sign informed consent (written or video documentation)
  • ECOG performance status of 0 to 2
  • Histologically confirmed squamous cell carcinoma
  • Tumor located in oral cavity, oropharynx, hypopharynx, or larynx
  • Any tumor grade and gender
  • Adequate bone marrow function within last 14 days: hemoglobin >10 g/dl (corrected), total leukocyte count >4,000 per cumm, platelet count >150,000 per cumm
  • Normal liver and kidney function
  • Nutritional and dental assessment before enrollment
Not Eligible

You will not qualify if you...

  • HPV (p16) positive tumors
  • Prior surgery or radiation therapy for any head and neck cancer
  • T1 or T2 glottis tumors
  • Metastatic disease or disease unfit for definitive locoregional treatment
  • Medical conditions preventing radiation or cisplatin chemotherapy
  • Pregnancy or lactation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, India, 110085

Actively Recruiting

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Research Team

S

Sarthak Tandon, DNB

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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