NCT Number: NCT06087614
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Phase 2
Delhi, 110085, India
Location status: Recruiting
Munish Gairola, MD, DNB Radiation Oncology
PRINCIPAL_INVESTIGATOR
Sarthak Tandon, DNB Radiation Oncology
CONTACT
(+91)11-47022009
Sarthak Tandon, DNB Radiation Oncology
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Concurrent chemotherapy, weekly Inj Cisplatin 40mg/m2. This will be given if clinically indicated
Standard institutional practice is detailed before starting the patient. Doses 66-70 Gy over 6-7 weeks
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
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.
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.
Time frame: Till 6 months of finishing radiotherapy
The acute toxicity will be measured by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
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)
Time frame: During treatment, at 3 month and 6 month interval of completion of radiotherapy
EORTC QLQ-C30
Time frame: During treatment, at 3 month and 6 month interval of completion of radiotherapy
QLQ-H&N35
Contact information is provided by the study sponsor or research team.
Rajiv Gandhi Cancer Institute & Research Center, India
Other
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
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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