Adaptive Radiotherapy for Head and Neck Cancer

(DEHART Trial)

Overseen By Medical College of Wisconsin Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Medical College of Wisconsin

Must not be taking: Immunosuppressants, Immunostimulatory agents

Disqualifiers: Prior malignancy, Autoimmune disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 3 weeks

18 Participants Needed

Trial Summary

What is the purpose of this trial?

Locoregional failure remains the principal mode of mortality in head and neck squamous cell carcinoma (HNSCC) treated with conventional chemoradiation therapy. Magnetic resonance-guided radiation therapy (MRgRT) allows for adaptive radiation dose escalation based on tumor response and may improve therapeutic outcomes while limiting toxicities. This protocol evaluates a novel framework for radiation delivery with concurrent atezolizumab in patients with advanced HNSCC. Dose-Escalated Hypofractionated Adaptive Radiotherapy (DEHART) modifies radiation dose using MRgRT by escalating radiation dose to residual tumor while deescalating radiation dose to areas of tumor regression.

Research Team

Musaddiq J. Awan

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

Adults aged 18+ with advanced head and neck squamous cell carcinoma, not suitable for standard chemotherapy due to age or health issues. Participants must have a specific level of organ function, no severe allergies to atezolizumab, and agree to use contraception if applicable. Excluded are those with certain recent illnesses, transplants, infections like HIV/HBV/HCV unless controlled, severe lung disease requiring oxygen therapy, or who are pregnant/breastfeeding.

Inclusion Criteria

You have experienced severe side effects from cancer treatment, as measured by the CARG toxicity score.

You have multiple chronic illnesses and your CIRS-G score is 4 or higher.

You have other medical conditions besides the one being studied, which have been evaluated using a specific tool called ACE-27, and your score is 1 or higher.

Exclusion Criteria

I have cancer spread that might cause pain or disability but hasn't yet.

I have not had major surgery in the last 28 days.

I haven't had major heart issues or strokes in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Dose-Escalated Hypofractionated Adaptive Radiotherapy (DEHART) with concurrent atezolizumab, with radiation doses of 50 Gy, 55 Gy, or 60 Gy administered in 15 fractions over 3 weeks

3 weeks

15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of dose-limiting toxicities and overall survival

12 months

Treatment Details

Interventions

• 50 Gy Radiation Therapy
• 55 Gy Radiation Therapy
• 60 Gy Radiation Therapy
• Atezolizumab

Trial Overview The trial tests adaptive radiotherapy doses alongside the drug atezolizumab in patients with head and neck cancer. The radiation dose is adjusted based on tumor response using MRgRT technology—increasing where the tumor persists and decreasing where it regresses—to improve outcomes while minimizing side effects.

Participant Groups

Group I: 60 Gray (Gy) Radiation Therapy Experimental Treatment 2 Interventions

60 Gy of ionizing radiation therapy will be administered in 15 fractions.

Group II: 55 Gray (Gy) Radiation Therapy Experimental Treatment 2 Interventions

55 Gy of ionizing radiation therapy will be administered in 15 fractions.

Group III: 50 Gray (Gy) Radiation Therapy Experimental Treatment 2 Interventions

50 Gy of ionizing radiation therapy will be administered in 15 fractions.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+