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Dose Escalation Using Hypoxia-adjusted Radiotherapy

Recruiting
18 - 70 years of age
Both
Phase 2

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Overview

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.

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 treatment protocol will also include concurrent chemotherapy with cisplatin at standard uniform dosing.

Patients with HNSCC whose cancer is determined to originate from the oral cavity, oropharynx, larynx, and hypopharynx will be selected. The included patients will be subjected to [18F] FMISO scan, labeled as baseline FMISO. Depending upon the result of the baseline FMISO, the patient will be either hypoxic or anoxic. Patients exhibiting no hypoxia in their tumor will be labeled as Arm 1 and act as an external cohort. Patients with hypoxia will be randomized (1:1) into two arms - Arms 2 and 3. Both arms will be subjected to chemoradiation by IMRT and concurrent chemotherapy with cisplatin at 40mg/m2. In Arm 3, the trial arm will receive an additional 10 Gy @ 2 Gy per fraction in phase II (total 80 Gy) to the HSV + 5mm isotropic margin.

One twenty-four patients will recruited in a 1:1 fashion between Arm 3 and Arm 2. The primary endpoint will be locoregional control and its possible increase in control.

Eligibility

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

Study details

Head and Neck Squamous Cell Carcinoma

NCT06087614

Rajiv Gandhi Cancer Institute & Research Center, India

30 March 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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