RCM/OCT-Guided Radiation Therapy for Basal Cell Carcinoma

Recruiting at 6 trial locations

Overseen By Anthony Rossi, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Radiation hypersensitivity, Prior cancer radiotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

38 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new way to use radiation therapy for treating basal cell carcinoma. The treatment uses an advanced imaging device to help doctors target the cancer more accurately. Researchers will also check for side effects and see how the treatment affects patients' quality of life. Electronic brachytherapy (EBT) is an emerging treatment technique for basal cell carcinoma (BCC).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of this treatment for basal cell carcinoma?

Research shows that radiation therapy is effective for treating basal cell carcinoma, especially in areas where preserving appearance and function is important, like the face. It is often preferred over surgery for certain skin cancers due to its ability to preserve normal tissue and achieve good cosmetic results. ^{1 2 3 4 5}

Is RCM/OCT-guided radiation therapy generally safe for humans?

Image-guided radiation therapy (IGRT) is considered safe and is widely used in clinical practice, as it allows for precise targeting of tumors while minimizing damage to surrounding healthy tissues. Studies have shown that advanced techniques like IGRT and intensity-modulated radiation therapy (IMRT) can reduce side effects and treatment-related toxicity compared to older methods. ^{6 7 8 9 10}

How is RCM/OCT-guided radiation therapy different from other treatments for basal cell carcinoma?

RCM/OCT-guided radiation therapy is unique because it uses advanced imaging techniques, reflectance confocal microscopy (RCM) and optical coherence tomography (OCT), to precisely target and treat basal cell carcinoma, potentially improving accuracy and outcomes compared to traditional methods. ^{1 11 12 13 14}

Research Team

Christopher Barker, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I can complete health surveys in English or Spanish.

My skin cancer has not grown deep into my skin.

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

Exclusion Criteria

I am willing to follow all treatment and follow-up procedures.

I've had radiotherapy that now makes further radiation unsafe, according to my doctor.

Medical contraindication to radiation therapy in the opinion of the investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pretreatment Imaging

Participants undergo pretreatment RCM/OCT imaging

1 week

Radiation Therapy

Participants receive radiation therapy guided by RCM/OCT

6 weeks

Post-treatment Assessment

Participants undergo post-treatment assessment with RCM/OCT and biopsy

1 week

Follow-up

Participants are monitored for clinical evidence of recurrence

up to 3 years

Treatment Details

Interventions

• Radiation Therapy
• Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided

Trial Overview 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.

Participant Groups

Group I: Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation Therapy Experimental Treatment 2 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.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in United States as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Physical Sciences Inc.

Collaborator

Trials

2

Recruited

50+

Findings from Research

Image-guided radiation therapy (IGRT) has evolved significantly and is now widely used in routine clinical practice, emphasizing the importance of quality and patient safety in its application across various treatment techniques and anatomical sites.

The American Society for Radiation Oncology recommends a comprehensive quality-assurance program and an interdisciplinary team approach to ensure IGRT is performed safely and effectively, highlighting the need for ongoing updates to practice guidelines as technology advances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. Qi, XS., Albuquerque, K., Bailey, S., et al.[2023]

In a study of 658 patients with high-risk endometrial cancer, intensity-modulated radiation therapy (IMRT) was associated with significantly fewer grade ≥2 adverse events, such as diarrhea and hematologic issues, compared to 3-dimensional conformal radiation therapy (3DCRT) during follow-up.

IMRT also showed a trend towards fewer patient-reported symptoms like bowel urgency and abdominal cramps during treatment, indicating it may provide a better quality of life for patients undergoing radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation Therapy Techniques and Treatment-Related Toxicity in the PORTEC-3 Trial: Comparison of 3-Dimensional Conformal Radiation Therapy Versus Intensity-Modulated Radiation Therapy. Wortman, BG., Post, CCB., Powell, ME., et al.[2022]

In a study of 22 patients with locally advanced rectal cancer, image-guided radiotherapy (IGRT) led to complete surgical resection in all cases, with 32% of patients showing no residual tumor after treatment.

The treatment was associated with minimal toxicity, although one patient experienced severe side effects likely due to an overdose of capecitabine, suggesting that IGRT is a promising approach for reducing complications in rectal cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of image-guided radiotherapy for locally advanced rectal cancer. Nguyen, NP., Ceizyk, M., Almeida, F., et al.[2011]

Intensity-modulated radiation therapy (IMRT) resulted in significantly lower rates of acute and late genitourinary (GU) and gastrointestinal (GI) toxicity compared to (125)I seed implants, with 3-year rates of 3.5% GU and 2.4% GI toxicity for IMRT versus 19.2% GU and 7.7% GI for (125)I.

Both treatments showed similar biochemical failure rates, with IMRT having a 4-year freedom from failure rate of 99.5% compared to 93.5% for (125)I, indicating that while both are effective, IMRT may be safer with fewer side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of acute and chronic toxicity for men with low-risk prostate cancer treated with intensity-modulated radiation therapy or (125)I permanent implant. Eade, TN., Horwitz, EM., Ruth, K., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Definitive and Postoperative Radiation Therapy for Basal and Squamous Cell Cancers of the Skin: Executive Summary of an American Society for Radiation Oncology Clinical Practice Guideline. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Proposed guidelines for appropriate utilization of superficial radiation therapy in management of skin cancers. Zemtsov-Cognetta criteria. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Selective use of radiation therapy for neoplasms of the skin. [2004]

4. United States pubmed.ncbi.nlm.nih.gov

Radiation Therapy for Cutaneous Malignancies of the Head and Neck. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Skin CanceR Brachytherapy vs External beam radiation therapy (SCRiBE) meta-analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Radiation Therapy Techniques and Treatment-Related Toxicity in the PORTEC-3 Trial: Comparison of 3-Dimensional Conformal Radiation Therapy Versus Intensity-Modulated Radiation Therapy. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Image guidance in radiation therapy for better cure of cancer. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of image-guided radiotherapy for locally advanced rectal cancer. [2011]

10. United States pubmed.ncbi.nlm.nih.gov

A comparison of acute and chronic toxicity for men with low-risk prostate cancer treated with intensity-modulated radiation therapy or (125)I permanent implant. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

In vivo optical coherence tomography of basal cell carcinoma. [2007]

12. England pubmed.ncbi.nlm.nih.gov

2021 international consensus statement on optical coherence tomography for basal cell carcinoma: image characteristics, terminology and educational needs. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Role of radiation therapy for facial skin cancers. [2019]

14. Germany pubmed.ncbi.nlm.nih.gov

Management of complex head-and-neck basal cell carcinomas using a combined reflectance confocal microscopy/optical coherence tomography: a descriptive study. [2022]