Cutaneous study: SBRT vs Standard Radiation
Official title Stereotactic Post-operative Radiotherapy for Intraparotid Metastatic Cutaneous Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT07337161
What this study is testing
- What it's testing
- The study compares how well stereotactic radiation works and its side effects against conventional radiation after the tumor has been surgically removed.
- Who it's for
- People who have had surgery for cutaneous squamous cell carcinoma of the head or neck.
- What's involved
- Participants will receive either stereotactic radiation (5 treatments) or standard radiation (20‑30 treatments) and will have scheduled visits and tests to monitor safety and outcomes.
- Time commitment
- Treatment lasts 5 or up to 30 sessions over several weeks, with follow‑up visits during and after the radiation course.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Patient able to provide informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patient is a candidate for curative intent treatment
- Patient is able to comprehend English adequately to complete patient reported outcome questionnaires
You likely can't join if
- Definite metastatic disease at diagnosis
- Pregnant or breastfeeding women
- Significant health conditions or contraindications to receiving surgery and radiation
- History of previous head and neck cancer within 5 years, except for localized skin cancers (i.e. no nodal or distant spread)
- Prior head and neck radiation involving the ipsilateral parotid or neck.
- Indications for contralateral neck radiation (i.e. contralateral or bilateral lymph nodes)
See the full eligibility criteria
- Age ≥ 18 years
- Patient able to provide informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patient is a candidate for curative intent treatment
- Patient is able to comprehend English adequately to complete patient reported outcome questionnaires
- Biopsy-confirmed cutaneous SCC
- Definitive resection of a primary cutaneous tumor within the head and neck
- Tumor stage T1-T4 (AJCC 8th edition); or tumor stage unknown (T0/Tx) with a positive intraparotid, peri-parotid or cervical node that is assumed to be from a head and neck cutaneous SCC by the treating oncologist
- Nodal stage N1-N3 (AJCC 8th edition)
- T3 or T4 tumor stage
- Lymphovascular invasion (LVI)
- Perineural invasion (PNI)
- Positive or close (≤ 3 mm) margin
- ≥ 1 positive intraparotid, peri-parotid or cervical lymph node
- Multiple local recurrences or multi-focal disease
- Neoadjuvant or adjuvant immunotherapy is allowed
- Definite metastatic disease at diagnosis
- Pregnant or breastfeeding women
- Significant health conditions or contraindications to receiving surgery and radiation
- History of previous head and neck cancer within 5 years, except for localized skin cancers (i.e. no nodal or distant spread)
- Prior head and neck radiation involving the ipsilateral parotid or neck. However, prior radiation to the index skin cancer that has led to the parotid nodal disease being treated on this trial is allowed, as long as...
- Indications for contralateral neck radiation (i.e. contralateral or bilateral lymph nodes)
- Previous invasive malignancy within 5 years, unless controlled with no evidence of disease
The study team makes the final eligibility decision.
Where it is enrolling
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at London, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.