- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05395962
Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer (Elechtra)
May 25, 2022 updated by: Anna Myriam Perrone, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer: the ElechtraPlatinum Study. A Randomized Controlled Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
92
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anna Myriam Perrone, MD
- Phone Number: +393498359048
- Email: myriam.perrone@aosp.bo.it
Study Locations
-
-
Bo
-
Bologna, Bo, Italy, 40138
- Recruiting
- IRCCS- Azienda Ospedaliera-Universitaria di Bologna
-
Principal Investigator:
- Giulia Dondi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: BLM
|
treatment with bleomycin in association with electroporation
|
EXPERIMENTAL: BLM+CBP
|
treatment with bleomycin in association with electroporation
treatment with bleomycin and carboplatin in association with electroporation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare Local progression-free survival
Time Frame: 5 years
|
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.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 5 years
|
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.
|
5 years
|
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.
Time Frame: 5 years
|
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.
|
5 years
|
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.
Time Frame: 5 years
|
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.
|
5 years
|
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.
Time Frame: 5 years
|
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.
|
5 years
|
Compare Overall Survival
Time Frame: 5 years
|
To compare Overall Survival in the two study arms.
|
5 years
|
Reporting of Adverse Events and Serious Adverse Events
Time Frame: 5 years
|
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.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 8, 2022
Primary Completion (ANTICIPATED)
April 7, 2025
Study Completion (ANTICIPATED)
April 7, 2027
Study Registration Dates
First Submitted
May 11, 2022
First Submitted That Met QC Criteria
May 25, 2022
First Posted (ACTUAL)
May 27, 2022
Study Record Updates
Last Update Posted (ACTUAL)
May 27, 2022
Last Update Submitted That Met QC Criteria
May 25, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 41/2022/Farm/AOUBo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vulvar Cancer
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Gynecologic Oncology GroupNational Cancer Institute (NCI)Active, not recruitingStage III Vulvar Cancer | Vulvar Squamous Cell Carcinoma | Stage I Vulvar Cancer | Stage II Vulvar CancerUnited States, Canada
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedLymphedema | Perioperative/Postoperative Complications | Stage II Vulvar Cancer AJCC v7 | Stage IIIA Vulvar Cancer AJCC v7 | Stage IIIB Vulvar Cancer AJCC v7 | Stage IIIC Vulvar Cancer AJCC v7 | Stage IVA Vulvar Cancer AJCC v7 | Stage IA Vulvar Cancer AJCC v7 | Stage IB Vulvar Cancer AJCC v7 | Stage IVB...United States
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