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NCT Number: NCT06087614

Dose Escalation Using Hypoxia-adjusted Radiotherapy

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.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, 110085, India

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DE-HyART

Radiation

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.

Other names: Dose escalated radiotherapy, Hypoxic sub volume, FMISO

Standard Arm

Radiation

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.

Other names: Standard Sequential fractionation without dose escalation

Cisplatin injection

Drug

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

Standard fractionation (Radiation Oncology preference)

Radiation

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

Primary outcomes

  1. Locoregional Control (LRC)

    Time frame: Disease recurrence locally or analysis cut-off point. The analysis cut off pint is 24 months

    LRC is defined as the absence of tumor recurrence or progression within the primary tumor site and the regional lymph nodes, as determined by clinical evaluation, imaging studies, and/or biopsy confirmation. LRC will be assessed at predefined time points, with the primary time point being 2 years post-treatment

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Death during following up or analysis cut-off point. The analysis cut off pint is 24 months

    The duration of OS was defined from the date of surgery to death from any cause. Therefore, if there is no death (for any reason), the OS duration will be cut-off at the analysis.

  2. Locoregional Relapse Free Survival (LRFS)

    Time frame: Disease/Death during following up or analysis cut-off point. The analysis cut off pint is 24 months

    LRFS is defined as the time from the date of randomization to the first histopathologically confirmed relapse of locoregional disease. If there is no confirmed recurrence, the LRC duration will be censored at the time of analysis. Death from any cause will be considered as an event in LRFS.

Other outcomes

  1. Acute toxicity

    Time frame: Till 6 months of finishing radiotherapy

    The acute toxicity will be measured by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  2. Late toxicity assessment

    Time frame: At 1 year and 2 year follow-up

    Measuring scale: (RTOG/European Organisation for the Research and Treatment of Cancer late toxicity criteria)

  3. Patient-reported outcome questionnaire

    Time frame: During treatment, at 3 month and 6 month interval of completion of radiotherapy

    EORTC QLQ-C30

  4. Patient-reported outcome QLQ-HN35 questionnaire

    Time frame: During treatment, at 3 month and 6 month interval of completion of radiotherapy

    QLQ-H&N35

Interested in participating?

Recruiting

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Sponsors and collaborators

Lead sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Other

Collaborators

  • Varian, a Siemens Healthineers Company

Registry information

Official study title

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

Acronym: DE-HyART

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 18, 2023
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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