Clinical trial · Observational
GISEL:Registry of Breast Cancer Patients Treated With ECT
GISEL (Italian Senologic Group for Electrochemotherapy): Prospective Multicenter Registry of Breast Cancer Patients With Skin Metastases Treated by Electrochemotherapy
NCT06683404CI-TRIAL-00082449GISELcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Electrochemotherapy (ECT) is a safe skin-directed treatment for cancer which combines drug treatment with short electric pulses to the tumor. The procedure lasts 20-40 minutes and is generally performed under sedation. It generally allows for a fast recovery with low discomfort. The aims of this study are to find out how well ECT works in patients with breast cancer that has spread to the skin (cutaneous metastases), and to find out which patients have the best response to the treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Metastatic | — | UNRESOLVED | — |
| Breast Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bleomycin | Drug | Bleomycin | ALIAS |
| Electrochemotherapy (ECT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast Cancer patients with cutaneous and/or subcutaneous histologically confirmed metastases
- description
- Breast Cancer patients with cutaneous and/or subcutaneous histologically confirmed metastases, regardless of the presence of other metastases, which underwent Electrochemotherapy for the local treatment of their cutaneous and/or subcutaneous metastases.
- interventionNames
- Device: Electrochemotherapy (ECT)
- Drug: Bleomycin
Primary outcomes (2)
- measure
- Local response
- timeFrame
- 4 and 8 weeks
- description
- Local response to the treatment, assessed using clinical examination and graded according to the Response Evaluation Criteria In Solid Tumors (RECIST).
- measure
- Treatment toxicity
- timeFrame
- 1 and 2 weeks and 1, 2, 3, 6 and 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Cutaneous metastases from breast cancer 2. No indication to surgical resection 3. No indication to treatment with radiotherapy 4. Ineligibility or unresponsiveness to systemic cancer treatment 5. Maximum tumor depth (from the skin layer): 3 cm 6. Patient's life expectancy greater than 4 months 7. Normal hematology, hepatic and renal function 8. Performance status (ECOG) ≤2 9. At least 18 years old Exclusion Criteria: 1. History of allergic reaction to bleomycin 2. Exceeding the maximum cumulative dose of bleomycin (250,000 IU / m2) 3. Severe impairment of lung, liver or kidney function 4. History of epilepsy 5. Presence of a cardiac pacemaker 6. Serious cardiac arrhythmias 7. Pregnancy or lactation 8. Unwillingness to attend the clinic for follow-up visits 9. Impaired respiratory function or presence of pulmonary fibrosis -
References
Publications (18)
- BACKGROUNDWong CY, Helm MA, Kalb RE, Helm TN, Zeitouni NC. The presentation, pathology, and current management strategies of cutaneous metastasis. N Am J Med Sci. 2013 Sep;5(9):499-504. doi: 10.4103/1947-2714.118918. PMID 24251266
- BACKGROUNDZagar TM, Higgins KA, Miles EF, Vujaskovic Z, Dewhirst MW, Clough RW, Prosnitz LR, Jones EL. Durable palliation of breast cancer chest wall recurrence with radiation therapy, hyperthermia, and chemotherapy. Radiother Oncol. 2010 Dec;97(3):535-40. doi: 10.1016/j.radonc.2010.10.020. Epub 2010 Nov 11. PMID 21074876
- BACKGROUNDOldenborg S, Van Os RM, Van rij CM, Crezee J, Van de Kamer JB, Rutgers EJ, Geijsen ED, Zum vorde sive vording PJ, Koning CC, Van tienhoven G. Elective re-irradiation and hyperthermia following resection of persistent locoregional recurrent breast cancer: A retrospective study. Int J Hyperthermia. 2010;26(2):136-44. doi: 10.3109/02656730903341340. PMID 20146568
- BACKGROUNDMatthiessen LW, Johannesen HH, Hendel HW, Moss T, Kamby C, Gehl J. Electrochemotherapy for large cutaneous recurrence of breast cancer: a phase II clinical trial. Acta Oncol. 2012 Jul;51(6):713-21. doi: 10.3109/0284186X.2012.685524. Epub 2012 Jun 26. PMID 22731832
- BACKGROUNDBelehradek M, Domenge C, Luboinski B, Orlowski S, Belehradek J Jr, Mir LM. Electrochemotherapy, a new antitumor treatment. First clinical phase I-II trial. Cancer. 1993 Dec 15;72(12):3694-700. doi: 10.1002/1097-0142(19931215)72:123.0.co;2-2. PMID 7504576
- BACKGROUNDHeller R, Jaroszeski MJ, Reintgen DS, Puleo CA, DeConti RC, Gilbert RA, Glass LF. Treatment of cutaneous and subcutaneous tumors with electrochemotherapy using intralesional bleomycin. Cancer. 1998 Jul 1;83(1):148-57. doi: 10.1002/(sici)1097-0142(19980701)83:13.0.co;2-w. PMID 9655305
- BACKGROUNDRodriguez-Cuevas S, Barroso-Bravo S, Almanza-Estrada J, Cristobal-Martinez L, Gonzalez-Rodriguez E. Electrochemotherapy in primary and metastatic skin tumors: phase II trial using intralesional bleomycin. Arch Med Res. 2001 Jul-Aug;32(4):273-6. doi: 10.1016/s0188-4409(01)00278-8.