FLASH Radiotherapy for Skin Cancer - Clinical Trial for Basal Cell Carcinoma | NCT05724875

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

FLASH RT

Conventional RT

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring FLASH therapy, basal cell carcinoma, cutaneous squamous cell carcinoma, high dose rate radiotherapy

Eligibility Criteria

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

Inclusion Criteria: Signed study Informed Consent Form Karnofsky Performance Status (KPS) ≥ 60 Age ≥ 60 years Patients with histologically proven cSCC or BCC Patients requiring radiotherapy treatment according to the dermato-oncology tumor board: patients who cannot undergo surgical procedure or patients who decline surgical resection, and/or anatomical locations where surgery can compromise function or cosmesis. T1-T2 N0 lesions with a small (T1; lesion ≤ 2cm in diameter) or large (T2; 2cm < lesion ≤ 4 cm) volume (TNM Classification of Malignant Tumours (TNM) Union for International Cancer Control (UICC), 8th Edition) Lesions should be at least 4 cm apart if treated with 2 different modalities (including surgical treatment of lesions). Lesions should not be located on the face, except on the forehead, above a line situated 1 cm above the eyebrows. Lesions located on the scalp can be treated. Exclusion Criteria: Previous radiotherapy in the treated area Concomitant auto-immune disease with skin lesions Concomitant use of radio-sensitizer drug Cognitive disorders not compatible with the signature of informed consent or that may compromise compliance with the requirements of the study Current, recent (within 10 days prior to start of study treatment), or planned participation in an experimental drug study (before end of treatment (EOT) visit) Concomitant use of systemic oncological treatment for a cancer other than the skin cancer(s)

Sites / Locations

Centre Hospitalier Universitaire Vaudois (CHUV)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: FLASH RT

Arm B: Conventional RT

Arm Description

Outcomes

Primary Outcome Measures

Frequency of ≥ grade 3 skin toxicity adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

To evaluate the safety of FLASH radiotherapy measured by the collection of ≥ grade 3 skin toxicity AEs according to CTCAE version 5.0. The severity of a specific event is graded i.e. mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4), or death (grade 5) using the CTCAE Grading Table.

Hierarchically tested efficacy measured by local control rate

At day 1, 21, 28, 42, and months 3, 6, and 12 post-treatment, the investigator will measure (with a caliper) the largest diameter of selected lesions for irradiation. Tumor response of each irradiated lesion will be assessed by the investigator as follow: Complete Response: the irradiated lesion is no more visualized Partial Response: the irradiated largest lesion dimension decreased by 30% at least from baseline (day 1) Progressive Disease: the irradiated largest lesion dimension increased by 20% at least from baseline (day 1) Stable Disease: no Complete Response, no Partial Response, no Progressive Disease

Secondary Outcome Measures

Frequency of acute side effects observed "in radiation field"

Frequency of late side effects observed "in radiation field"

Evaluation of tumor response

Blinded Imaging Central Review (BICR) of photographs will evaluate tumor response by grading the size of the residual tumor in comparison to the size of the tumor on the day of irradiation (in percentage). 0% means no residual tumor and treatment success, 100% or more indicate a total lack of tumor response. A baseline photograph will be taken the day of the treatment (day 1) in a pre-therapeutic setting with skin delineation of the lesion. Then photos will be repeated at day 21 (+/-2d), day 28 (+/-2d), day 42 (+/-3d) after treatment, then at 3 (+/-7d), 6 (+/-14d), 12 (+/-14d) months after treatment, and at progression.

Evaluation of "in radiation field" normal tissues reaction around the treated tumors

Blinded Imaging Central Review (BICR) of photographs will evaluate "in radiation field" normal tissues reaction around the treated tumors by grading radiation induced skin reactions, grade 1-5, using the CTCAE scale. A baseline photograph will be taken the day of the treatment (day 1) in a pre-therapeutic setting with skin delineation of the lesion. Then photos will be repeated at day 21 (+/-2d), day 28 (+/-2d), day 42 (+/-3d) after treatment, then at 3 (+/-7d), 6 (+/-14d), 12 (+/-14d) months after treatment, and at progression.

Epidermis thickness measured by Optical coherence tomography (OCT)

Epidermis thickness in micrometer will be measured by OCT and compared between irradiated skin and normal non-irradiated skin

Epidermis roughness measured by OCT

Epidermis roughness in micrometer will be measured by OCT and compared between irradiated skin and normal non-irradiated skin

Plexus depth measured by OCT

Plexus depth in micrometer will be measured by OCT and compared between irradiated skin and normal non-irradiated skin

Vessel density measured by OCT

Vessel density, expressed as percent of the surface covered by the vessels in the examined area, will be measured by OCT and compared between irradiated skin and normal non-irradiated skin

Size of vessels measured by OCT

Mean size (in micrometer) of all vessels in the examined area will be measured by OCT and compared between irradiated skin and normal non-irradiated skin

Number of hairs counted by OCT

Number of hairs in the examined area will be counted by OCT and compared between irradiated skin and normal non-irradiated skin

Size of hairs measured by OCT

Mean size (in micrometer) of all hairs in the examined area will be measured by OCT and compared between irradiated skin and normal non-irradiated skin

Full Information

NCT ID

NCT05724875

First Posted

January 17, 2023

Last Updated

June 23, 2023

Sponsor

Centre Hospitalier Universitaire Vaudois

1. Study Identification

Unique Protocol Identification Number

NCT05724875

Brief Title

FLASH Radiotherapy for Skin Cancer

Acronym

LANCE

Official Title

Randomized Phase II Selection Trial of FLASH Versus Conventional Radiotherapy for Patients With Localized Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 22, 2023 (Actual)

Primary Completion Date

September 2026 (Anticipated)

Study Completion Date

September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre Hospitalier Universitaire Vaudois

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a single center randomized selected Phase II study of FLASH radiotherapy (RT) versus standard of care (SOC) radiotherapy in patients with localized Cutaneous Squamous Cell Carcinoma (cSCC) or Basal Cell Carcinoma (BCC). In summary, the aims of the study are to describe and compare the toxicity and efficacy of high dose rate radiotherapy (FLASH therapy) to SOC conventional radiotherapy (according to the standard guidelines per lesion size) through a randomized Phase II selection study in patients presenting localized cSCC or BCC requiring a radiotherapy treatment.

6. Conditions and Keywords

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

Basal Cell Carcinoma, Cutaneous Squamous Cell Carcinoma

Keywords

FLASH therapy, basal cell carcinoma, cutaneous squamous cell carcinoma, high dose rate radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A: FLASH RT

Arm Type

Experimental

Arm Title

Arm B: Conventional RT

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

FLASH RT

Other Intervention Name(s)

High dose rate radiotherapy

Intervention Description

For T1 (small) lesions: 22 Gy single dose FLASH RT; For T2 (large) lesions: 5 x 6 Gy fractionated dose FLASH RT

Intervention Type

Device

Intervention Name(s)

Conventional RT

Intervention Description

For T1 (small) lesions: 22 Gy single dose conventional RT; For T2 (large) lesions: 5 x 6 Gy fractionated dose conventional RT

Primary Outcome Measure Information:

Title

Frequency of ≥ grade 3 skin toxicity adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Description

To evaluate the safety of FLASH radiotherapy measured by the collection of ≥ grade 3 skin toxicity AEs according to CTCAE version 5.0. The severity of a specific event is graded i.e. mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4), or death (grade 5) using the CTCAE Grading Table.

Time Frame

up to 6 weeks after radiotherapy

Title

Hierarchically tested efficacy measured by local control rate

Description

At day 1, 21, 28, 42, and months 3, 6, and 12 post-treatment, the investigator will measure (with a caliper) the largest diameter of selected lesions for irradiation. Tumor response of each irradiated lesion will be assessed by the investigator as follow: Complete Response: the irradiated lesion is no more visualized Partial Response: the irradiated largest lesion dimension decreased by 30% at least from baseline (day 1) Progressive Disease: the irradiated largest lesion dimension increased by 20% at least from baseline (day 1) Stable Disease: no Complete Response, no Partial Response, no Progressive Disease

Time Frame

From Day 1 up to 12 months post-treatment

Secondary Outcome Measure Information:

Title

Frequency of acute side effects observed "in radiation field"

Time Frame

up to 3 months after radiotherapy

Title

Frequency of late side effects observed "in radiation field"

Time Frame

from ≥ 3 months after radiotherapy until 12 months post-treatment start

Title

Evaluation of tumor response

Description

Blinded Imaging Central Review (BICR) of photographs will evaluate tumor response by grading the size of the residual tumor in comparison to the size of the tumor on the day of irradiation (in percentage). 0% means no residual tumor and treatment success, 100% or more indicate a total lack of tumor response. A baseline photograph will be taken the day of the treatment (day 1) in a pre-therapeutic setting with skin delineation of the lesion. Then photos will be repeated at day 21 (+/-2d), day 28 (+/-2d), day 42 (+/-3d) after treatment, then at 3 (+/-7d), 6 (+/-14d), 12 (+/-14d) months after treatment, and at progression.

Time Frame

From Day 1 up to 12 months post-treatment

Title

Evaluation of "in radiation field" normal tissues reaction around the treated tumors

Description

Blinded Imaging Central Review (BICR) of photographs will evaluate "in radiation field" normal tissues reaction around the treated tumors by grading radiation induced skin reactions, grade 1-5, using the CTCAE scale. A baseline photograph will be taken the day of the treatment (day 1) in a pre-therapeutic setting with skin delineation of the lesion. Then photos will be repeated at day 21 (+/-2d), day 28 (+/-2d), day 42 (+/-3d) after treatment, then at 3 (+/-7d), 6 (+/-14d), 12 (+/-14d) months after treatment, and at progression.

Time Frame

From Day 1 up to 12 months post-treatment

Title

Epidermis thickness measured by Optical coherence tomography (OCT)

Description

Epidermis thickness in micrometer will be measured by OCT and compared between irradiated skin and normal non-irradiated skin

Time Frame