Dose Escalation Using Hypoxia-adjusted Radiotherapy

Last updated: January 16, 2025
Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
Overall Status: Active - Recruiting

Phase

2

Condition

Head And Neck Cancer

Squamous Cell Carcinoma

Treatment

Standard fractionation (Radiation Oncology preference)

Cisplatin injection

Standard Arm

Clinical Study ID

NCT06087614
Res/SCM/58/2023/33
  • Ages 18-70
  • All Genders

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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 124
Treatment Group(s): 4
Primary Treatment: Standard fractionation (Radiation Oncology preference)
Phase: 2
Study Start date:
April 08, 2024
Estimated Completion Date:
April 30, 2028

Study 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.

Connect with a study center

  • Rajiv Gandhi Cancer Institute and Research Centre

    Delhi, 110085
    India

    Active - Recruiting

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