Status:
RECRUITING
Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Vulvar Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Patients with vulvar cancer who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy), or patients not eligible for stan...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Recurrent VC confirmed by histological examination
- Patient who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy).
- Patient not eligible for standard therapies (surgery, radiation therapy and systemic chemotherapy in case of metastatic disease) due to the performance status (ECOG Performance Status ≥ 3 )
- Life expectancy more than three months
- Measurable disease according to RECIST 1.1
- Adequate bone marrow, liver, and kidney function (creatinine \<1.5 mg/dl), and coagulation parameters as follows:
- Bone marrow (Hemoglobin ≥ 8.0 g/dL with or without transfusion support, Platelet count ≥ 75 × 109/L?) o INR \>1.5;
- Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvate transaminase (SGPT) ≤3.0 × upper limit of normal (ULN)
- Total bilirubin ≤2.0 × ULN or ≤3 × ULN except for subjects with Gilbert's syndrome
- Serum creatinine \<1.5 mg/dl and creatinine clearance \> 30 ml/min All blood assessments must be performed within 15 days from ECT treatment.
- For females of childbearing potential, a negative serum pregnancy human chorionic gonadotropin (hCG) pregnancy test within 72 hours of study Day 1.
- Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply the study requirements.
Exclusion
- History of other malignancies in the previous five years, except basal cell carcinoma of the skin.
- History of psychological, familial, sociological, or geographical condition potentially preventing compliance with the study protocol and follow-up schedule.
- Allergic reactions to the two chemotherapy drugs (BLM and AUC2-CARBOPLATIN) and/or their excipients.
- Evidence of pulmonary fibrosis.
Key Trial Info
Start Date :
April 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 7 2027
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT05395962
Start Date
April 8 2022
End Date
April 7 2027
Last Update
May 27 2022
Active Locations (1)
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1
IRCCS- Azienda Ospedaliera-Universitaria di Bologna
Bologna, Bo, Italy, 40138