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Dose Escalation Using Hypoxia-adjusted Radiotherapy

NCT06087614 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2025-01-17

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

DE-HyART

The HSV delineation will be done for patients in arm 3 using baseline FMISO. The HSV will be contoured and adjusted according to the second FMISO scan done between the 4th - the 5th week of radiation treatment. A planning CT will also be repeated at the time for adjusting the HSV to account for temporal changes. The Biological Target Volume thus generated after adequate margins will be prescribed 30 Gy in 10 fractions over and above the standard fractination.

RADIATION

Standard Arm

The prescribed radiotherapy dose will be 70 Gy in 2 Gy per fraction daily. The elective volume will be treated with 50 Gy in 2 Gy per fraction daily till the first 5 weeks. The entire treatment will be delivered in a phased mannered using sequential planning.

DRUG

Cisplatin injection

Concurrent chemotherapy, weekly Inj Cisplatin 40mg/m2. This will be given if clinically indicated

RADIATION

Standard fractionation (Radiation Oncology preference)

Standard institutional practice is detailed before starting the patient. Doses 66-70 Gy over 6-7 weeks

Sponsors & Collaborators

  • Varian, a Siemens Healthineers Company

    collaborator INDUSTRY

  • Rajiv Gandhi Cancer Institute & Research Center, India

    lead OTHER

Principal Investigators

  • Munish Gairola, MD,DNB Radiation Oncology · Rajiv Gandhi Cancer Institute and Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-08
Primary Completion
2028-04-30
Completion
2028-04-30

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06087614 on ClinicalTrials.gov