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Stereotactic Post-operative Radiotherapy for Intraparotid Metastatic Cutaneous Squamous Cell Carcinoma

ConditionsCutaneousHead and Neck Cancer Squamous Cell Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid Palma

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • SBRT

    Radiation

    Patients 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

  • Standard Radiation

    Radiation

    Patients 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

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Arm 1: ControlActive comparator 1 intervention
Group B: Arm 2: SBRT armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Tumor control

Tumor control within the irradiated field at 2 years following adjuvant radiation completion defined as absence of clinical, radiographic or biopsy-proven recurrence within the irradiated field

Time frame
2 years

Secondary outcomes

1

Regional recurrence

calculated as time from randomization to evidence of disease recurrence anywhere in the ipsilateral parotid gland or neck

Time frame
2 years
2

Disease-free survival (DFS)

calculated as time from randomization to evidence of recurrence at any site, death from any cause, or last follow-up, whichever occurs first. New primary cutaneous SCC of the head or neck will not be counted towards DFS events.

Time frame
2 years
3

Overall survival

calculated as time from randomization to death from any cause, or last follow-up, whichever occurs first.

Time frame
2 years
4

Rate of salvage surgery

calculated as time from randomization to salvage surgery in the ipsilateral treated neck. Freedom from unsalvageable parotid/neck recurrence will be documented as time from randomization to evidence of recurrence in the ipsilateral parotid gland or neck that cannot be salvaged (either surgery or radiation), or last follow-up, whichever occurs first.

Time frame
2 years

Other outcomes

Sponsors and contacts

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

David Palma

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor institution

Source ClinicalTrials.gov
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