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Dose Escalation Using Hypoxia-adjusted Radiotherapy

ConditionHead and Neck Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRajiv Gandhi Cancer Institute & Research Center, India

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age: 18 - 70 years

Willingness to sign informed consent (written/video documentation)

Performance status: ECOG 0 - 2

Histology proved - squamous cell carcinoma

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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

Treatment groups

124 Participants
are divided into 3 treatment groups
Group A: Arm 3 - DE-HyARTExperimental treatment 2 interventions
Group B: Arm 2 - Hypoxic Comparator ArmActive comparator 2 interventions
Group C: Arm 1 - Non-hypoxic armPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Locoregional Control (LRC)

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

Secondary outcomes

1

Overall Survival (OS)

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
Death during following up or analysis cut-off point. The analysis cut off pint is 24 months
2

Locoregional Relapse Free Survival (LRFS)

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

Other outcomes

1

Acute toxicity

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

Time frame
Till 6 months of finishing radiotherapy
2

Late toxicity assessment

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

Time frame
At 1 year and 2 year follow-up
3

Patient-reported outcome questionnaire

EORTC QLQ-C30

Time frame
During treatment, at 3 month and 6 month interval of completion of radiotherapy
4

Patient-reported outcome QLQ-HN35 questionnaire

QLQ-H\&N35

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rajiv Gandhi Cancer Institute & Research Center, India

Lead sponsor

Varian, a Siemens Healthineers Company

Collaborator

Source ClinicalTrials.gov
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