Back to results

Rhenium-Skin Cancer Therapy (SCT) for the Treatment of Non-Melanoma Skin Cancer. (EPIC-Skin)

Primary Purpose

Non-melanoma Skin Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Rhenium-SCT

About this trial

This is an interventional treatment trial for Non-melanoma Skin Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Stage I or II BCC or SCC (SCC Well to Moderately Differentiated), and clinically node negative disease
Confirmed Histology, and with depth of lesion noted
Subjects with up to 3 lesions suitable to enter the study (subjects with more than 3 lesions are not excluded from the study, however 3 target lesions are determined for study evaluation only.)
Subjects able and willing to comply with the requirements of the study
Age >=18 years
Informed Consent signed by the subject consenting to undergo the study
Lesions up to 8cm2
Lesions with a depth up to 3mm confirmed on biopsy report AND deemed appropriate clinically by treating clinician
Subjects who are not deemed suitable for surgery, for example due to tumour location, performance status or other comorbidities as deemed relevant by the treating clinician
Patients who may have declined Surgery and/or fractionated Radiation Therapy

Exclusion Criteria:

Inability to personally provide written informed consent or to understand and collaborate throughout the study
Inability or unwillingness to comply with study requirements
Prior treatment with surgery or radiation therapy for their target lesion(s)
Depth of lesion greater than 3mm as defined by Biopsy and/or clinical assessment
Lupus and Scleroderma
Basal cell naevus syndrome, xeroderma, vitiligo and albinism
Prior laser at the tumour site
Malignant melanoma systemic therapy ongoing
Any ongoing treatment for malignancy, or in the last 4 weeks prior to study entry
A tumour affecting nerves or bony structures
Clinical concern of metastatic disease
Pregnancy and/or Lactation
Pathological exclusions: Perineural Invasion, Lymphovascular invasion
Anatomical exclusions: NMSC's of the Medial canthus, eyelid margin (upper and lower), Vermillion lip

Sites / Locations

Genesis Care Health Hub at RNSRecruiting
John Flynn HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment arm

Arm Description

Treatment with Rhenium-SCT, Single treatment.

Outcomes

Primary Outcome Measures

Complete Response (CR) with Modified Visual RECIST tool

To assess the proportion of lesions achieving complete response (CR) as per MODIFIED VISUAL RECIST criteria

Secondary Outcome Measures

SKINDEX-16 QoL Questionnaire

The QoL questionnaire will be scored according to the author's instructions. Change from baseline in score will be calculated. Descriptive statistics will be presented for actual score and change from baseline by timepoint, overall and by tumour type (BCC/SCC).

Comfort of Treatment short questionnaire

Comfort of treatment assessed using a short questionnaire completed by subjects post treatment with Rhenium-SCT. The frequency (and percentage) of subjects reporting each option for each question will be presented.

cosmetic outcomes by Visual Analogue Scale

Cosmetic outcome assessed by subject and Clinician, using Visual Analogue Scale. Descriptive statistics will be presented overall and by tumour type (BCC or SCC). A mixed model will be fitted with Visual Analogue Scale as the outcome variable. Tumour type and tumour stage will be included as factors. Other relevant prognostic factors assessed at Baseline will be included. From the model the adjusted mean score will be obtained and presented with 95% confidence limits. Adjusted mean score will be estimated overall and by tumour type.

Full Information

NCT ID

NCT05135052

First Posted

October 8, 2021

Last Updated

March 30, 2022

Sponsor

OncoBeta Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT05135052

Brief Title

Rhenium-Skin Cancer Therapy (SCT) for the Treatment of Non-Melanoma Skin Cancer.

Acronym

EPIC-Skin

Official Title

Efficacy of Personalised Irradiation With Rhenium-Skin Cancer Therapy (SCT) for the Treatment of Non-Melanoma Skin Cancer: A Phase IV, Multi-Centre, International, Open-Label, Single Arm Study.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 17, 2022 (Actual)

Primary Completion Date

July 15, 2023 (Anticipated)

Study Completion Date

May 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

OncoBeta Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Efficacy of Personalised Irradiation with Rhenium-Skin Cancer Therapy (SCT) for the treatment of non-melanoma skin cancer; a phase IV multi-centre, international, open label, single arm study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-melanoma Skin Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment arm

Arm Type

Experimental

Arm Description

Treatment with Rhenium-SCT, Single treatment.

Intervention Type

Device

Intervention Name(s)

Rhenium-SCT

Intervention Description

Rhenium-SCT irradiation device

Primary Outcome Measure Information:

Title

Complete Response (CR) with Modified Visual RECIST tool

Description

To assess the proportion of lesions achieving complete response (CR) as per MODIFIED VISUAL RECIST criteria

Time Frame

12 months

Secondary Outcome Measure Information:

Title

SKINDEX-16 QoL Questionnaire

Description

Time Frame

6 months and 12 months

Title

Comfort of Treatment short questionnaire

Description

Time Frame

14 days

Title

cosmetic outcomes by Visual Analogue Scale

Description

Time Frame

12 months and 24 months

Other Pre-specified Outcome Measures:

Title

Safety as assessed by CTCAE v4.0

Description

Adverse events by severity and by relationship to Rhenium-SCT, including radiation dermatitis, dry skin, skin ulceration, alopecia, skin induration, hypo/hyperpigmentation, and telangiectasia. Adverse events will be coded using MedDRA and comprehensively summarised by System Organ Class (SOC) and Preferred Term (PT) overall, by severity and by relationship to Rhenium-SCT.

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Stage I or II BCC or SCC (SCC Well to Moderately Differentiated), and clinically node negative disease Confirmed Histology, and with depth of lesion noted Subjects with up to 3 lesions suitable to enter the study (subjects with more than 3 lesions are not excluded from the study, however 3 target lesions are determined for study evaluation only.) Subjects able and willing to comply with the requirements of the study Age >=18 years Informed Consent signed by the subject consenting to undergo the study Lesions up to 8cm2 Lesions with a depth up to 3mm confirmed on biopsy report AND deemed appropriate clinically by treating clinician Subjects who are not deemed suitable for surgery, for example due to tumour location, performance status or other comorbidities as deemed relevant by the treating clinician Patients who may have declined Surgery and/or fractionated Radiation Therapy Exclusion Criteria: Inability to personally provide written informed consent or to understand and collaborate throughout the study Inability or unwillingness to comply with study requirements Prior treatment with surgery or radiation therapy for their target lesion(s) Depth of lesion greater than 3mm as defined by Biopsy and/or clinical assessment Lupus and Scleroderma Basal cell naevus syndrome, xeroderma, vitiligo and albinism Prior laser at the tumour site Malignant melanoma systemic therapy ongoing Any ongoing treatment for malignancy, or in the last 4 weeks prior to study entry A tumour affecting nerves or bony structures Clinical concern of metastatic disease Pregnancy and/or Lactation Pathological exclusions: Perineural Invasion, Lymphovascular invasion Anatomical exclusions: NMSC's of the Medial canthus, eyelid margin (upper and lower), Vermillion lip

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gerhard Dr Dahlhoff, MD

Phone

08136808989

gerhard.dahlhoff@oncobeta.com

First Name & Middle Initial & Last Name or Official Title & Degree

Sam Dr Vohra, PhD

Phone

+61450556969

sam@avionmedical.com.au

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerhard Dr Dahlhoff, MD

Organizational Affiliation

Oncobeta GmbH

Official's Role

Study Director

Facility Information:

Facility Name

Genesis Care Health Hub at RNS

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Angela Prof Hong

Facility Name

John Flynn Hospital

City

Tugun

State/Province

Queensland

ZIP/Postal Code

4224

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sid Prof Baxi

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Rhenium-Skin Cancer Therapy (SCT) for the Treatment of Non-Melanoma Skin Cancer.

We'll reach out to this number within 24 hrs