| Eligibility |
Inclusion Criteria:
1. Histologically confirmed newly diagnosed or recurrent (local) vulva SCC with or
without distant metastases within 12 months
2. Tumor size = 7 centimeters in the longest diameter.
3. Targeted lesion must be technically amenable for complete coverage (including margins)
by the Alpha DaRT sources.
4. Measurable target according to RECIST v1.1
5. Interstitial implant indication validated by multidisciplinary team.
6. ECOG Performance Status =3.
7. Life expectancy =6 months.
8. Women Age =18
9. Willing and have the ability to provide signed Informed Consent.
10. Willing to use an acceptable contraceptive method to prevent pregnancy for 3 months
after RT.
11. Blood tests values:
- Leucocytes =3000mm3,
- Absolute neutrophil count =1500mm3,
- Platelets =100,000 mm3,
- Total bilirubin = 1.5xULN,
- AST, SGOT, SGPT =2.5xULN, If Alkaline Phosphatase = 4xULN, then transaminases are
normal.
- Creatinine = 2.0xULN.
- INR or Prothrombin time =1.5xULN.
Exclusion Criteria:
1. Concomitant chemotherapy or immunotherapy within the past 4 weeks
2. Fit for surgical exploration unless the patient refuses surgery
3. Known hypersensitivity to any of the components of the treatment.
4. Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief
use of systemic corticosteroids.
5. Longest tumor diameter >7 cm.
6. Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart
Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy,
uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial
infarction in the last 12 months.
7. Patients with uncontrolled intercurrent illnesses including, but not limited to an
active infection requiring systemic therapy (not including cholangitis) or a known
psychiatric or substance abuse disorder(s) that would interfere with cooperation with
the requirements of the trial or interfere with the study endpoints.
8. Has a known additional malignancy that is progressing or requires active treatment.
Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the
skin that has undergone potentially curative therapy or in situ cervical cancer.
9. Patient requires treatment not specified in this protocol which may conflict with the
endpoints of this study including evaluation of response or toxicity of Alpha DaRT.
10. Volunteers participating in another interventional study in the past 30 days which
might conflict with the endpoints of this study or the evaluation of response or
toxicity of Alpha DaRT.
11. High probability of protocol non-compliance (in opinion of investigator).
12. Breastfeeding women or women of childbearing potential unwilling or unable to use an
acceptable contraceptive method to prevent pregnancy for 3 months after RT.
13. Subjects not willing to sign an informed consent
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