What side effects are associated with this type of intervention?

Radiation therapy (RT) for Basal Cell Carcinoma (BCC) can cause side effects such as skin irritation, redness, and blistering at the treatment site. Long-term effects may include changes in skin color and texture. Other common treatments for BCC include surgical excision, which can lead to scarring and infection, and topical treatments like imiquimod or 5-fluorouracil, which may cause local skin reactions such as redness, swelling, and peeling. Photodynamic therapy (PDT) can result in photosensitivity, leading to redness and swelling in treated areas. The use of RCM/OCT-guided RT aims to improve precision and minimize these side effects by targeting the cancer more accurately.

What prior FDA approvals exist?

FDA-approved treatments for Basal Cell Carcinoma (BCC) include surgical excision, Mohs micrographic surgery, and topical therapies such as imiquimod and 5-fluorouracil. Additionally, vismodegib and sonidegib, which are hedgehog pathway inhibitors, have been approved for advanced BCC. While specific FDA approvals for radiation therapy guided by imaging technologies like RCM/OCT are not detailed, traditional radiation therapy remains a standard treatment option for BCC, particularly for patients who are not candidates for surgery.

What other types of research exist?

Promising novel alternatives to Radiation Therapy guided by RCM/OCT for Basal Cell Carcinoma patients include: 1) Vismodegib, a hedgehog pathway inhibitor, which has shown efficacy in advanced BCC cases. 2) Immunotherapy, particularly checkpoint inhibitors, which are being explored for their potential in treating BCC. 3) Photodynamic therapy (PDT), which uses light-activated drugs to target cancer cells with precision. These alternatives offer targeted treatment options that aim to improve outcomes and reduce side effects.

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RCM/OCT-Guided Radiation Therapy for Basal Cell Carcinoma

Phase 2

Recruiting

Led By Christopher Barker, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No deep invasion (beyond subcutaneous fat or >6 mm from granular layer of dermis to deepest point of carcinoma)

Biopsy proven basal cell carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Awards & highlights

Study Summary

This trial will test a new cancer treatment device to see if it is effective against basal cell carcinoma, as well as look at any potential side effects. The device uses radiation therapy, and researchers will also study quality of life before and after treatment.

Who is the study for?

This trial is for adults with biopsy-proven basal cell carcinoma (BCC) that's not deeply invasive or larger than 40mm. Up to three tumors can be treated, and they mustn't have bone erosion or significant nerve invasion. Participants need to understand English/Spanish for questionnaires and be considered suitable for RCM/OCT imaging and radiation therapy by the investigator.Check my eligibility

What is being tested?

The study tests if guiding radiation therapy with a new device combining reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) is effective in treating BCC. It also examines side effects of this guided RT and assesses patients' quality of life before and after treatment through questionnaires.See study design

What are the potential side effects?

While specific side effects are not listed, typical ones from radiation therapy may include skin irritation, redness, peeling at the treatment site, fatigue, mild swelling, or changes in skin coloration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My skin cancer has not grown deep into my skin.

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I have been diagnosed with basal cell carcinoma through a biopsy.

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My cancer has not spread to my nerves.

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My cancer is in an early stage (T1 or T2).

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My cancer lesion is 40 mm or smaller.

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My cancer has not damaged my bones.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

histologic tumor response rate

Secondary outcome measures

frequency and severity of adverse events

Trial Design

1Treatment groups

Experimental Treatment

Group I: Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation TherapyExperimental Treatment2 Interventions

If eligible, patients will undergo pretreatment RCM/OCT imaging, followed by RT. Six weeks after the completion of RT, patients will undergo post-treatment assessment with RCM/OCT and biopsy. If residual carcinoma is detected on the biopsy, surgical excision of the BCC will be performed. If no residual carcinoma is detected on the biopsy, the patient will be monitored for clinical evidence of recurrence for up to 3 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Basal Cell Carcinoma (BCC) include surgical excision, topical therapies, photodynamic therapy, and radiation therapy. Surgical excision involves physically removing the tumor, ensuring clear margins to prevent recurrence. Topical therapies, such as imiquimod and 5-fluorouracil, work by stimulating the immune system or inhibiting DNA synthesis in cancer cells, respectively. Photodynamic therapy uses a photosensitizing agent activated by light to destroy cancer cells. Radiation therapy, particularly when guided by imaging technologies like Reflectance Confocal Microscopy (RCM) and Optical Coherence Tomography (OCT), delivers targeted radiation to the tumor site. This precision minimizes damage to surrounding healthy tissue and reduces side effects, making it a valuable option for patients with BCC, especially those with tumors in challenging locations or those who are not candidates for surgery.

Carbon ion radiotherapy for basal cell adenocarcinoma of the head and neck: preliminary report of six cases and review of the literature.Stereotactic body radiotherapy treatment of extracranial metastases.A survey on staging and treatment in uterine cervical carcinoma in the Radiotherapy Cooperative Group of the European Organization for Research and Treatment of Cancer.