RecruitingPhase 2NCT06087614

Dose Escalation Using Hypoxia-adjusted Radiotherapy

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


Sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Enrollment

124 participants

Start Date

Apr 8, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adjusting the dose of radiation therapy based on how much oxygen is in a tumor (a technique called hypoxia-guided radiotherapy) can improve outcomes for people with head and neck squamous cell cancer. Tumors with low oxygen levels are often harder to treat with standard radiation. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with squamous cell carcinoma of the mouth, throat, voice box, or hypopharynx, confirmed by biopsy - You are in acceptable physical condition (ECOG 0–2) - Your blood counts and organ function are within acceptable limits - You have completed dental and nutritional assessments before starting **You may NOT be eligible if...** - Your tumor tests positive for HPV (p16-positive) - You have had prior surgery or radiation for head and neck cancer - You have early-stage voice box (glottis) cancer (T1/T2) - Your cancer has spread to distant organs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONDE-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.

RADIATIONStandard 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.

DRUGCisplatin injection

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

RADIATIONStandard fractionation (Radiation Oncology preference)

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


Locations(1)

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, India

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NCT06087614


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