Back to resultsElectrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer (Elechtra)
Primary Purpose
Vulvar Cancer
Status
Recruiting
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Carboplatin
Bleomycin
Sponsored by
About this trial
This is an interventional treatment trial for Vulvar Cancer
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- IRCCS- Azienda Ospedaliera-Universitaria di BolognaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
BLM
BLM+CBP
Arm Description
Outcomes
Primary Outcome Measures
Compare Local progression-free survival
Evaluate the oncology response to electroporation after administration of BLM + CBP to BLM alone in terms of local progression-free survival (LPFS) in women with relapsed vulvar cancer after multimodal treatments.
Secondary Outcome Measures
Compare Health-Related Quality of life (HR-QoL) in patients undergoing BLM + AUC2-CARBOPLATIN vs BLM alone assessed with questionnaires in patients undergoing BLM + CBP vs BLM alone assessed with questionnaires.
Paper or electronic questionnaires will be given to the patient at baseline (within 30 days prior to randomization) and then at every follow-up visit within the first year after randomization.The significance and relevance of the data need to be explained carefully to participating patients so that they are motivated to comply with data collection. The patient must complete the questionnaire him/herself without receiving help from relatives, friends or clinic staff to answer the questionnaire. However, if the patient is unable to read the questionnaire (e.g., is blind or illiterate) the questionnaire may be read out by trained clinic staff and responses recorded.
Compare Health-Related Quality of life (HR-QoL) in the two study arms assessed with the EQ-5D-5L (5-level EQ-5D version) questionnaire.
The EQ-5D-5L descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each of the five dimensions.
Compare Health-Related Quality of life (HR-QoL) in the two study arms assessed with the FACT-V (Functional Assessment of Cancer Therapy-Vulva) questionnaire.
The FACT-V is a supplemental module that contains questions specifically related to the quality of life of patients with VC. The survey assesses the impacts of cancer therapy in four domains: physical, social/family, emotional, and functional. The response scale is a 5-point Likert type scale. The FACT-V is also has additional questions regarding issues that may be affected by vulvar cancer.
Compare Health-Related Quality of life (HR-QoL) in the two study arms assessed with the FACIT-PAL ( Functional Assessment of Chronic Illness Therapy - Palliative Care) questionnaire.
The FACIT-PAL ( is a 19-item palliative care subscale with items that pertain to persons with life-limiting illness. This questionnaire has items that pertain to symptoms that can be seen in advanced illness (e.g., shortness of breath, constipation, xerostomia), family and friend relationships (e.g., feeling appreciated by family, being a burden to family, maintaining contact with friends), life closure issues (e.g., having "made peace" with others, feeling hopeful, making "each day count"), and decision-making and communication abilities. The response scale is a 5-point Likert type scale.
Compare Overall Survival
To compare Overall Survival in the two study arms.
Reporting of Adverse Events and Serious Adverse Events
Toxicity will be evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events) criteria based on AE (Adverse Events) related or possibly related to the procedure and the drugs utilized, and to SAE (Serious Adverse Event) and AESI (Adverse Events of Special Interest), whether or not the event is considered treatment related.
Full Information
NCT ID
NCT05395962
First Posted
May 11, 2022
Last Updated
May 25, 2022
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT05395962
Brief Title
Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer
Acronym
Elechtra
Official Title
Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer: the ElechtraPlatinum Study. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2022 (Actual)
Primary Completion Date
April 7, 2025 (Anticipated)
Study Completion Date
April 7, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 standard therapies.
The study aims to:
Evaluate the oncology response to electroporation after administration of Bleomycin (BLM) + carboplatinum (CBP )to BLM alone in terms of local progression-free survival (LPFS) in women with relapsed vulvar cancer after multimodal treatments.
Compare quality of life (HR-QoL) in the two groups of patients with questionnaires (FACT-V, FACT-PAL, E5-5L-D5).
To compare Overall Survival in the two study arms.
To compare local and systemic toxicity, morbidity and mortality, intraoperative and post-operative complications among the two study arms.
To compare costs and cost-effectiveness between the two study arms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BLM
Arm Type
Active Comparator
Arm Title
BLM+CBP
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
treatment with bleomycin and carboplatin in association with electroporation
Intervention Type
Drug
Intervention Name(s)
Bleomycin
Intervention Description
treatment with bleomycin in association with electroporation
Primary Outcome Measure Information:
Title
Compare Local progression-free survival
Description
Evaluate the oncology response to electroporation after administration of BLM + CBP to BLM alone in terms of local progression-free survival (LPFS) in women with relapsed vulvar cancer after multimodal treatments.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Compare Health-Related Quality of life (HR-QoL) in patients undergoing BLM + AUC2-CARBOPLATIN vs BLM alone assessed with questionnaires in patients undergoing BLM + CBP vs BLM alone assessed with questionnaires.
Description
Paper or electronic questionnaires will be given to the patient at baseline (within 30 days prior to randomization) and then at every follow-up visit within the first year after randomization.The significance and relevance of the data need to be explained carefully to participating patients so that they are motivated to comply with data collection. The patient must complete the questionnaire him/herself without receiving help from relatives, friends or clinic staff to answer the questionnaire. However, if the patient is unable to read the questionnaire (e.g., is blind or illiterate) the questionnaire may be read out by trained clinic staff and responses recorded.
Time Frame
5 years
Title
Compare Health-Related Quality of life (HR-QoL) in the two study arms assessed with the EQ-5D-5L (5-level EQ-5D version) questionnaire.
Description
The EQ-5D-5L descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each of the five dimensions.
Time Frame
5 years
Title
Compare Health-Related Quality of life (HR-QoL) in the two study arms assessed with the FACT-V (Functional Assessment of Cancer Therapy-Vulva) questionnaire.
Description
The FACT-V is a supplemental module that contains questions specifically related to the quality of life of patients with VC. The survey assesses the impacts of cancer therapy in four domains: physical, social/family, emotional, and functional. The response scale is a 5-point Likert type scale. The FACT-V is also has additional questions regarding issues that may be affected by vulvar cancer.
Time Frame
5 years
Title
Compare Health-Related Quality of life (HR-QoL) in the two study arms assessed with the FACIT-PAL ( Functional Assessment of Chronic Illness Therapy - Palliative Care) questionnaire.
Description
The FACIT-PAL ( is a 19-item palliative care subscale with items that pertain to persons with life-limiting illness. This questionnaire has items that pertain to symptoms that can be seen in advanced illness (e.g., shortness of breath, constipation, xerostomia), family and friend relationships (e.g., feeling appreciated by family, being a burden to family, maintaining contact with friends), life closure issues (e.g., having "made peace" with others, feeling hopeful, making "each day count"), and decision-making and communication abilities. The response scale is a 5-point Likert type scale.
Time Frame
5 years
Title
Compare Overall Survival
Description
To compare Overall Survival in the two study arms.
Time Frame
5 years
Title
Reporting of Adverse Events and Serious Adverse Events
Description
Toxicity will be evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events) criteria based on AE (Adverse Events) related or possibly related to the procedure and the drugs utilized, and to SAE (Serious Adverse Event) and AESI (Adverse Events of Special Interest), whether or not the event is considered treatment related.
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Myriam Perrone, MD
Phone
+393498359048
Email
myriam.perrone@aosp.bo.it
Facility Information:
Facility Name
IRCCS- Azienda Ospedaliera-Universitaria di Bologna
City
Bologna
State/Province
Bo
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Myriam Perrone, MD
Phone
+39 051 2144392
Email
myriam.perrone@unibo.it
First Name & Middle Initial & Last Name & Degree
Anna Myriam Perrone
First Name & Middle Initial & Last Name & Degree
Pierandrea De IAco
First Name & Middle Initial & Last Name & Degree
Giulia Dondi
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer
We'll reach out to this number within 24 hrs