Groin Sentinel Node Biopsy and 18FDG-PET/CT in cN0 Vulvar Cancer Patients Candidate to Standard Lymphadenectomy

Learn more about:
Related Clinical Trial
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

Groin Sentinel Node Biopsy and 18FDG-PET/CT in cN0 Vulvar Cancer Patients Candidate to Standard Lymphadenectomy

Official Title

Study on the Prediction of Groin Lymphonodal Status Through 18FDG-PET/CT Combined With Sentinel Lymph Node Biopsy in Bulky a/o Multifocal a/o Pretreated Vulvar Cancer, N0 at Conventional Imaging (GRO-SNaPET Study)

Brief Summary

      The study aim is to verify the accuracy of SNB combined with 18F-FDG PET/CT in cN0 invasive
      vulvar cancer (IVC) patients currently not candidate to SNB according to standard guidelines.
    

Detailed Description

      Vulvar carcinoma (VC) is a rare disease (4% of gynecological cancers) and the treatment is
      not yet universally defined. No official guidelines are currently available to define imaging
      techniques useful for staging. In the pre-operative evaluation of the pateints, imaging
      should assess nodal status; the available exams are:

        -  CT or MRI with contrast (abdominal and pelvic with caudal scans for inguinal regions)

        -  Inguinal ultrasound with US-guided biopsy/fine needle aspiration for suspicious lymph
           nodes.

      The incidence of inguinal and pelvic lymph node metastasis not diagnosed at the pre-operative
      imaging is 10-35% as assessed after lymphadenectomy at pathology report.

      Until 2009, the standard surgical treatment of vulvar cancer was represented by mono or
      bilateral systematic lymphadenectomy (at least 70% of N0 women underwent a radical surgery
      with the risk of severe morbidity related to the surgical procedure with no survival
      benefit).

      Inguinal lymphadenectomy shows a high rate of local and systemic complications resulting in a
      longer hospitalization or recovery, as well as possible delays in adjuvant therapies.

      Moreover, severe complications can lead to a further surgery.

      Possibile complications described in literature are:

        -  Lymphedema (up to 70%)

        -  Infection and postoperative cellulitis (50%)

        -  Inguinal suture dehiscence (between 22 and 52%)

        -  Linfocysts (between 7 and 28%)

        -  Deep vein thrombosis (between 5 and 8%)

        -  Sepsis (1 -2%)

      Since 2009, with the introduction and the validation of sentinel node biopsy (SNB), for some
      VC it is now possible to obtain a nodal staging with minimally invasive surgery and lower
      morbidity. However, the SNB technique is indicated if the tumor fits the following selection
      criteria:

        -  Infiltrating tumors with a diameter < 40 mm;

        -  Monofocal tumors;

        -  Tumors distant more than 1 cm from the midline

        -  Tumors near the midline with bilateral lymphatic drainage and intraoperative detection
           of at least one sentinel node for each groin.

      Consequently in many tumors diagnosed as N0 at preoperative imaging, SNB technique is not
      indicated; these tumors still require systematic lymphadenectomy.

      In this subset of patients it is important to identify new methods for preoperative
      evaluation of nodal status or to define a sub-category of patients for which the SNB could be
      applied.

      Objective of the study is to verify, in patients actually off-label for SNB, the accuracy of
      18FDG-PET/CT in predicting nodal status, as an indipendent method or associated with the
      standard pre-operative imaging and the mini-invasive surgical staging.

      All patients are submitted to:

        -  Gynecologic visit

        -  Vulvar biopsy and possible pelvic examination under anesthesia with the definition of
           clinical extent of disease

        -  Evaluation of serum tumor markers: SCC and Ca125

        -  Inguinal ultrasound and possible US guided FNAC or FNAB on suspicious lymph nodes

        -  CT scan (abdomen and pelvis) with contrast

        -  18FDG-PET/CT

        -  Lymphangioscintigraphy of inguinofemoral axis

      Vulvar surgery may include:

        -  Wide resection of vulvar disease

        -  Emivulvectomy (anterior, posterior or lateral)

        -  Simple vulvectomy

        -  Radical or ultra-radical vulvectomy (with possible plastic reconstruction)

      During inguinal surgery all patients will undergo:

      - Sentinel node biopsy mono or bilateral followed by radical bilateral inguinal
      lymphadenectomy

      Statistical analysis will help determine the accuracy and negative predictive value of
      FDG-PET/CT and sentinel node biopsy in predicting nodal status.
    


Study Type

Interventional


Primary Outcome

Accuracy and Negative Predictive Value of sentinel node biopsy in cN0 vulvar cancer patients that do not fit for the current indications

Secondary Outcome

 Accuracy and Negative Predictive Value of preoperative 18F FDG-PET/CT for the selection of cN0 patients.

Condition

Vulvar Cancer

Intervention

18FDG-PET/TC

Study Arms / Comparison Groups

 Vulvar cancer patients cN0 unfit for sentinel node biopsy
Description:  All invasive vulvar cancer patients with cN0 status:
T > 4 cm;
multicentric tumors (mono or bilateral);
primary lesion completely excised during prior diagnostic surgery
patients candidate to bilateral lymphadenectomy because of unilateral groin lymph node involvement, contralateral cN0
previous radiotherapy a/o chemotherapy (sequential or concurrent). These patients are submitted to 18FDG PET/TC and sentinel node biopsy associated with standard preoperative imaging and radical groin lymphadenectomy

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

Procedure

Estimated Enrollment

50

Start Date

July 2013

Completion Date

July 2017

Primary Completion Date

July 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Age> 18 years

          -  ECOG ≤ 2

          -  Adequate respiratory, hepatic, cardiac, bone marrow and renal function (creatinine
             clearance> 60 mL/min according to the Cockroft formula)

          -  Patient psychologically able to follow the study procedures

          -  Signature of informed consent

        In addition, both major criteria and at least one of the minor criteria must be present:

        MAJOR CRITERIA

          -  Vulvar carcinoma (stromal infiltration > 1 mm); Histotypes different from squamous are
             included

          -  Negative lymphnodes at preoperative imaging

        MINOR CRITERIA

          -  Vulvar lesion greater than 4 cm

          -  Multifocal or bilateral lesions

          -  Previous complete excisional biopsy of the vulvar lesion, with absent residual disease

          -  Previous neoadjuvant treatment (radiotherapy a/o sequential/concomitant chemotherapy)

          -  Previous treatment with radiotherapy a/o chemotherapy (sequential a/o concomitant) for
             previous vulvar cancer a/o other diseases

          -  Previous vulvar or inguinal surgery

          -  Infiltrating vulvar carcinoma with monolateral groin lymphnode involvement (N1) and
             contralateral N0

        Exclusion Criteria:

          -  Allergy to egg proteins and albumin

          -  Pregnancy and breastfeeding

          -  Patients with impaired respiratory, hepatic, cardiac, bone marrow and renal function
             (creatinine clearance> 60 mL / min according to the Cockroft formula)

          -  Patients with major depressive disorder
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT02969278

Organization ID

GroSNaPET


Responsible Party

Principal Investigator

Study Sponsor

Catholic University of the Sacred Heart


Study Sponsor

, , 


Verification Date

November 2016