Study of Electronic Brachytherapy for Cutaneous Basal Cell Carcinoma

NCT02939027 | Completed

• 1 other identifier: BCCBrachy
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Electronic brachytherapy (EBT) offers an isotope-free radiation therapy modality for the treatment of specific skin lesions, especially non-melanoma skin cancers (NMSC). Within the treatment of NMSC, surgical removal of the lesion is currently the treatment of choice for the majority of cases. However in an estimated 10-15% of NMSC patients, surgery might not be the best treatment option. Location of the tumour in cosmetically sensitive areas, patient comorbidities, old age, use of anti-coagulation etc. might all be reasons to select radiotherapy as first choice of treatment. The objective of ths study will be to determine histologically confirmed clinical efficacy, safety, and usability of Electronic Brachytherapy, an innovative treatment for Basal Cell Carcinoma (BCC).

Conditions

Carcinoma, Basal Cell

Outcome Measures

Primary Outcomes (6)

• Clinical Response of Electronic Brachytherapy

  Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).

  2 weeks after treatment

• Clinical Response of Electronic Brachytherapy

  Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).

  6 weeks after treatment

• Clinical Response of Electronic Brachytherapy

  Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).

  3 months after treatment

• Clinical Response of Electronic Brachytherapy

  Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).

  6 months after treatment

• Clinical Response of Electronic Brachytherapy

  Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).

  12 months after treatment

• Clinical Response of Electronic Brachytherapy

  Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).

  24 months after treatment

Secondary Outcomes (3)

• Patient quality of life

  Before treatment and at 3 months post treatment.

• Rate of grade ≥3-4 adverse events

  2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment.

• Caregiver experience (questionnaire)

  3 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

For the first 20 patients, a total dose of 36.6 Gy is planned over 6 fractions of 6.1 Gy, given 2 days week, 3 weeks or lees at least 2 days apart each fraction.

Device: Electronic Brachytherapy (6,1 Gy)

Group 2

EXPERIMENTAL

For the next 20 patients a total dose of 42 Gy is planned over 6 fractions of 7 Gy, given 2 days week 3 weeks or lees at least 2 days apart each fraction.

Device: Electronic Brachytherapy (7 Gy)

Interventions

Electronic Brachytherapy (6,1 Gy) DEVICE

A total dose of 36.6 Gy is planned over 6 fractions of 6.1 Gy, given 2 days/week, during 3 weeks or lees, at least 2 days apart each fraction.

Group 1

Electronic Brachytherapy (7 Gy) DEVICE

A total a dose of 42 Gy is planned over 6 fractions of 7 Gy, given 2 days/week during 3 weeks or lees, at least 2 days apart each fraction.

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women ≥18 years old.
• Estimated life expectancy of ≥5 years
• Histopathologic diagnosis of early and primary Basal Cell Carcinoma (BCC)
• Clinical stage of BCC: T1 or T2 (by AJCC 2010 criteria, see Table 1)
• Histological subtypes: Superficial BCC or nodular BCC
• Maximum diameter of lesion: 20 mm
• Maximum depth of invasion: 4 mm.
• Ability to provide informed consent
• Punch biopsy of primary tumor to depth of reticular dermis

You may not qualify if:

• Men or women \<18 years old.
• Estimated life expectancy \<5 years.
• BCC that was previously treated (ie, recurrent BCC)
• BCC in region adjacent to or overlapping with region of prior radiotherapy
• BCC on irregular surface (ie, target area not flat)
• BCC adjacent to or overlapping with burn or scar
• BCC in area prone to trauma
• BCC in area with compromised lymphatic drainage or vascular supply
• Inflammatory process in target area
• Pregnancy or lactation
• Collagen vascular disease (lupus, scleroderma, rheumatoid arthritis)
• Diabetes that is poorly controlled (Hg A1c \>7%)
• Genetic disorder predisposing patient to skin cancers or radiation sensitivity (basal cell nevus syndrome, xeroderma pigmentosum, ataxia telangiectasia mutans)
• Receipt of treatment with another investigational device or drug
• Receipt of drug that will affect biologic response to radiation (radiosensitizer or radioprotector)

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 19, 2016
• Study Start: July 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 19, 2016

Record last verified: 2016-10