Stereotactic Radiotherapy for Skin Cancer

(SPRINT Trial)

Overseen By Palma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: David Palma

Disqualifiers: Metastatic disease, Pregnant, Significant health conditions, others

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

Compensation: Varies

Number of Visits: 7

Duration: 4 to 6.5 weeks for conventional, 1-2 weeks for stereotactic

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to compare the effectiveness and side effects of stereotactic radiotherapy (5 sessions) against conventional (standard) radiotherapy (20-30 sessions) for the treatment of skin cancer involving the head and neck after surgical resection.

Stereotactic radiotherapy works in the same way that conventional (standard) radiotherapy does to kill cancer cells by damaging their genetic material and stopping the cancer cells from making copies of themselves.

This study will help the study doctors find out if this different approach is the same, better, or worse than the standard of care for your cancer.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain stages of skin cancer in the head and neck area, who have had surgery to remove it. They must be able to understand English, give informed consent, and have a performance status that allows them to carry out daily activities with some limitations.

Inclusion Criteria

My cancer is at a stage where it has grown into surrounding tissues.

I am 18 years old or older.

I can understand and agree to the study's procedures and risks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either conventional fractionation radiation over 4 to 6.5 weeks or ultra-hypofractionated stereotactic radiation over 5 treatments

4 to 6.5 weeks for conventional, 1-2 weeks for stereotactic

5 to 33 visits (in-person)

Follow-up

Participants are monitored for tumor control, regional recurrence, disease-free survival, overall survival, and radiation-associated toxicity

2 years

Regular visits at 2 weeks, 4 weeks, 3, 12, 18, 24 months post-treatment, and yearly from years 2-5

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiotherapy (SBRT)

Trial Overview

The study compares stereotactic radiotherapy (5 sessions) versus conventional radiotherapy (20-30 sessions) after surgical removal of skin cancer in the head and neck. It aims to determine if this new approach is as effective or better than standard treatment.

How Is the Trial Designed?

Group I: Arm 2: SBRT arm Experimental Treatment 1 Intervention

Patients in Arm 2 will receive ultra-hypofractionated stereotactic radiation over 5 treatments delivered every other weekday or twice weekly as follows: * 40 to 42.5 Gy in 5 fractions: any areas of gross residual disease, or gross PNI on imaging * 32.5 to 35 Gy in 5 fractions: microscopic areas at risk including positive margin and/or ENE * 30 Gy in 5 fractions: entire operative bed including areas of primary tumor and involved nodes and dissected cervical nodal levels * 27.5 to 30 Gy 5 fractions: at risk undissected cervical nodal levels adjacent to pathologically involved nodal levels, based on the discretion of the treating oncologist

Group II: Arm 1: Control Active Control 1 Intervention

Patients in Arm 1 will receive daily conventional fractionation radiation over 4 or 6-6.5 weeks based on the treating oncologist's discretion. The below dose levels are recommended in the following clinical scenarios but may be modified per institutional standards: 20-fraction regimen or 30 to 33-fraction regimen

Who Is Running the Clinical Trial?

David Palma

Lead Sponsor

Trials

4

Recruited

530+