A Safety and Efficacy Study of Intra-tumoural Diffusing Alpha Radiation Emitters for the Treatment of Vulva Cancer

Learn more about:
Related Clinical Trial
Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study Education, Immigration and HPV Vaccination: an Informational Randomized Trial Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years Serial MRI Scans During Radiation Therapy A Safety and Efficacy Study of Intra-tumoural Diffusing Alpha Radiation Emitters for the Treatment of Vulva Cancer Indocyanine Green Fluorescence Imaging, Sentinel Lymph Node Mapping in Patients With Vulvar Cancer Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Cisplatin+Pembrolizumab+RT in Vulvar Cancer Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations Developing a Stepped Approach to Improving Sexual Function aFteR Treatment fOr gyNaecological Cancer Integrating a Health Information Technology System for Primary and Secondary Cervical Cancer Prevention Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery MR-HIFU for Recurrent Gynaecological Cancer Pelvic Floor Disorders in Survivors of Gynecologic Malignancies Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life Paclitaxel Therapeutic Drug Monitoring in Cancer Patients Validation of a Nutrition Screening Tool A Survivorship Care Plan for Gynaecological Cancer Patients Self-Advocacy Serious Game in Advanced Cancer Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED) Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001) Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002) Chemoradiation-Induced Nausea and Emesis: Quality of Life A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021) A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002) Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy Phase I Study of Intravenous Triapine (IND # 68338) in Combination With Pelvic Radiation Therapy With or Without Weekly Intravenous Cisplatin Chemotherapy for Locally Advanced Cervical, Vaginal, or Pelvic Gynecologic Malignancies ChemoFx® PRO – A Post-Market Data Collection Study Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Colposcopy and High Resolution Anoscopy in Screening For Anal Dysplasia in Patients With Cervical, Vaginal, or Vulvar Dysplasia or Cancer Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life The Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology Study Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer Image-Guided Gynecologic Brachytherapy Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cancer, or Endometrial Cancer Topical Imiquimod in Treating Patients With Recurrent Paget’s Disease of the Vulva Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox. The Impact of the “WOMAN-PRO II Program” on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence CaptHPV : Validation of the Method “CaptHPV” for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers Effectiveness of an Individualized Symptom Education Program (ISEP) A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006) Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection Study to Evaluate the Role of PlasmaJet in Patients Undergoing Groin Node Dissection for Vulval Cancer Bioimpedance Spectroscopy in Detecting Lower-Extremity Lymphedema in Patients With Stage I, Stage II, Stage III, or Stage IV Vulvar Cancer Undergoing Surgery and Lymphadenectomy Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva Added-value of SPECT/CT in Patients Undergoing LM/SL for Gynecological Cancers Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer OCT-AF Imaging of Pre-cancers of Vulva and Cervix Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva Groin Sentinel Node Biopsy and 18FDG-PET/CT in cN0 Vulvar Cancer Patients Candidate to Standard Lymphadenectomy Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients. Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer Sentinel Node Extended in Squamous Cell Vulvar Cancer Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer. Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva

Brief Title

A Safety and Efficacy Study of Intra-tumoural Diffusing Alpha Radiation Emitters for the Treatment of Vulva Cancer

Official Title

A Safety and Efficacy Study of Intra-tumoural Diffusing Alpha Radiation Emitters (DaRT) for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva

Brief Summary

      An investigation to investigate the use of diffusing alpha-emitters radiation therapy (DaRT)
      for the treatment of new and recurrent squamous cell carcinoma of the vulva.
    

Detailed Description

      Squamous cell carcinoma of the vulva is a rare cancer accounting for less than 1% of female
      cancers. The disease predominantly affects women over the age of 65 although the incidence in
      younger women is rising, a finding that has been attributed to the effect of increasing human
      papillomavirus (HPV) infection .

      The standard treatment for the primary tumour is surgical excision with the aim of achieving
      a 1 cm clear margin on histopathology. This requires the surgeon to remove 1.5-2 cm of
      surrounding normal tissue to allow for shrinkage after tissue fixation. Depending on the size
      and location of the tumour, the surgical procedure could vary from a wide local excision to a
      radical vulvectomy, including excision of adjacent structures such as the clitoris, lower
      urethra or anus, and/or reconstructive surgery. Wound infection and breakdown are common
      short-term complications of radical vulva surgery. Long term consequences include functional,
      cosmetic, psychological and psychosexual sequelae, which can have a significant negative
      impact on quality of life.

      Recurrence rates for vulva squamous cell carcinomas range from 15% to 33%. Local recurrence
      in the vulva is the most common site of relapse (70%) with the groin nodes affected in 24%,
      pelvic nodes in 16% and distant metastases in 19%. The treatment of choice for local
      recurrence is surgical excision and 5-year survival rates of up to 45% have been reported.
      However, patients can develop multiple recurrences over a period of time and the feasibility
      of surgery becomes increasingly more limited as more and more tissue is removed.

      Brachytherapy is a form of radiotherapy where radiation sources are placed directly in
      contact with or into (interstitial) cancerous tissue. The radiation emitted has a short range
      in tissue and the brachytherapy dose distribution conforms tightly to the location of the
      sources with minimal dose to the surrounding healthy tissues.

      Alpha Tau Medical Ltd. proposes a novel treatment for malignant tumours using intra-tumoural
      alpha radiation, which is delivered using the Alpha DaRT Device (Alpha DaRT applicator +
      Alpha DaRT seeds). The technique, known as Diffusing Alpha-emitters Radiation Therapy (DaRT),
      combines the advantages of conventional interstitial brachytherapy with the destructive power
      of alpha particles.
    


Study Type

Interventional


Primary Outcome

Assess the feasibility of DaRT by the safety of DaRT for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva

Secondary Outcome

 Assess the efficacy of DaRT for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva

Condition

Vulva Cancer, Recurrent

Intervention

DaRT Diffusing Alpha-emitters Radiation Therapy

Study Arms / Comparison Groups

 DaRT Diffusing Alpha-emitters Radiation Therapy
Description:  DaRT Diffusing Alpha-emitters Radiation Therapy using the DaRT applicator and seeds, inserted for 14 days prior to removal.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Radiation

Estimated Enrollment

10

Start Date

May 1, 2021

Completion Date

May 1, 2023

Primary Completion Date

November 1, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Newly diagnosed or recurrent (local) vulva cancer with or without distant metastases

          -  Histopathological confirmation of squamous cell carcinoma

          -  Macroscopic tumour in situ (i.e. tumour not excised)

          -  Age 18 years and over

          -  ECOG performance status 0-2

          -  Life expectancy more than 6 months

          -  Willing and able to give written informed consent to participate

          -  Measurable target according to RECIST v1.1

          -  Tumour size ≤ 7 centimetres in the longest diameter

          -  Target is technically amenable for full coverage by the DaRT seeds

        Exclusion Criteria:

          -  Non-squamous histology

          -  Concomitant illnesses which may increase risk of radiation toxicity e.g. autoimmune
             diseases, vasculitis, etc.

          -  Concomitant immunosuppressive and/or long-term corticosteroid treatment

          -  Involvement in other studies that may affect evaluation of response or toxicity of
             DaRT in the past 30 days or 5 half-lives of the investigational product, whichever is
             longer

          -  Pregnancy or breastfeeding

          -  Women of child-bearing potential unwilling to use adequate contraception for the
             duration of the study and 6 months after completion (further details in CIP section
             13)

          -  Nodal recurrence without local recurrence

          -  Previous diagnosis of other malignancy < 3 years of enrolment (excluding
             non-melanomatous skin cancer)

          -  No concurrent chemotherapy

          -  Patients who have received prior chemotherapy or targeted therapy require a 1-month
             washout before DaRT insertion

          -  Requirement to start chemotherapy within 6 weeks of DaRT insertion
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Li Tee Tan, 01223216083, [email protected]



Administrative Informations


NCT ID

NCT04761146

Organization ID

DaRT-V


Responsible Party

Sponsor-Investigator

Study Sponsor

CCTU- Cancer Theme

Collaborators

 Alpha Tau Medical LTD.

Study Sponsor

Li Tee Tan, Principal Investigator, Cambridge University Hospitals NHS Foundation Trust


Verification Date

February 2021