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Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva

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ClinicalTrials.gov Identifier: NCT01595061
Recruitment Status : Recruiting
First Posted : May 9, 2012
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Tracking Information
First Submitted Date  ICMJE May 8, 2012
First Posted Date  ICMJE May 9, 2012
Last Update Posted Date March 12, 2019
Actual Study Start Date  ICMJE July 2, 2012
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2014)
Complete pathologic response evaluated as the frequency of complete clinical and pathologic response after primary therapy [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
Complete pathologic response (pCR) evaluated as the frequency of complete clinical and pathologic response after primary therapy
Change History Complete list of historical versions of study NCT01595061 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
  • Complete clinical response, defined as no clinical/radiographic evidence of primary disease (vulvar or groin) following chemo-radiation therapy [ Time Frame: 6 weeks ]
  • Incidence and severity of adverse effects tabulated based on the Common Terminology Criterial for Adverse Events (CTCAE) v 4.0 [ Time Frame: Up to 5 years ]
    Maximum grade of treatment related adverse effects will be tabulated based CTCAE v 4.0 grading system.
  • Progression-free survival (PFS) [ Time Frame: From start of protocol therapy to date of reappearance of disease or date of last contact, assessed up to 5 years ]
    Product-limit estimates according to the method of Kaplan and Meier will be calculated to assess duration of PFS among the entire study cohort and by response status.
  • Site(s) of disease recurrence/relapse [ Time Frame: Up to 5 years ]
    Site(s) of first disease recurrence will be classified as: local (vagina or vulva), loco-regional (within the pelvic) or distant and tabulated by response status.
  • Overall survival (OS) [ Time Frame: From start of protocol therapy to death or, for living patients, the date of last contact, assessed up to 5 years ]
    Product-limit estimates according to the method of Kaplan and Meier will be calculated to assess duration of OS among the entire study cohort and by response status.
  • Treatment compliance, including treatment span, incidence and duration of treatment delay, reasons for delays, chemotherapy dose, radiation dose and reasons for dose level reductions [ Time Frame: Up to 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
  • Complete clinical response
  • Incidence and severity of adverse effects tabulated based on the Common Terminology Criterial for Adverse Events (CTCAE) v 4.0
  • Progression-free survival (PFS) estimated according to the method of Kaplan and Meier
  • Overall survival (OS) estimated according to the method of Kaplan and Meier
  • Site(s) of disease recurrence/relapse classified as local (vagina or vulva), loco-regional (within the pelvic), or distant tabulated by response status
  • Treatment compliance
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva
Official Title  ICMJE A Phase II Trial Evaluating Cisplatin (NSC #119875) and Gemcitabine (NSC #613327) Concurrent With Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva (NCT #01595061)
Brief Summary This phase II trial studies how well radiation therapy works when given with gemcitabine hydrochloride and cisplatin work in treating patients with squamous cell cancer of the vulva that has spread from where it started to nearby tissue or lymph nodes. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.
Detailed Description

PRIMARY OBJECTIVES:

I. To determine the efficacy of cisplatin, gemcitabine (gemcitabine hydrochloride), and intensity-modulated radiation therapy (IMRT) in achieving a complete pathologic response when used for the primary treatment of locally-advanced squamous cell carcinoma of the vulva.

SECONDARY OBJECTIVES:

I. To determine the efficacy of cisplatin, gemcitabine, and IMRT in achieving a complete clinical response when used for the primary treatment of locally-advanced squamous cell carcinoma of the vulva.

II. To determine the vulvar progression-free survival and groin progression-free survival in women treated with cisplatin, gemcitabine and IMRT for locally advanced vulvar carcinoma.

III. To determine the toxicity and surgical morbidity of the combined modality approach of cisplatin, gemcitabine and IMRT followed by reduced-scope surgery for the treatment of locally-advanced vulvar carcinoma.

OUTLINE:

Patients undergo IMRT 5 days a week for 6 weeks. Patients also receive gemcitabine hydrochloride intravenously (IV) over 30 minutes and cisplatin IV over 60 minutes weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after completion of chemoradiation patients undergo local core biopsy to confirm response or surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stage IIIA Vulvar Cancer AJCC v7
  • Stage IIIB Vulvar Cancer AJCC v7
  • Stage IIIC Vulvar Cancer AJCC v7
  • Stage IVA Vulvar Cancer AJCC v7
  • Vulvar Squamous Cell Carcinoma
Intervention  ICMJE
  • Drug: Cisplatin
    Given IV
    Other Names:
    • Abiplatin
    • Blastolem
    • Briplatin
    • CDDP
    • Cis-diammine-dichloroplatinum
    • Cis-diamminedichloridoplatinum
    • Cis-diamminedichloro Platinum (II)
    • Cis-diamminedichloroplatinum
    • Cis-dichloroammine Platinum (II)
    • Cis-platinous Diamine Dichloride
    • Cis-platinum
    • Cis-platinum II
    • Cis-platinum II Diamine Dichloride
    • Cismaplat
    • Cisplatina
    • Cisplatinum
    • Cisplatyl
    • Citoplatino
    • Citosin
    • Cysplatyna
    • DDP
    • Lederplatin
    • Metaplatin
    • Neoplatin
    • Peyrone's Chloride
    • Peyrone's Salt
    • Placis
    • Plastistil
    • Platamine
    • Platiblastin
    • Platiblastin-S
    • Platinex
    • Platinol
    • Platinol- AQ
    • Platinol-AQ
    • Platinol-AQ VHA Plus
    • Platinoxan
    • Platinum
    • Platinum Diamminodichloride
    • Platiran
    • Platistin
    • Platosin
  • Drug: Gemcitabine Hydrochloride
    Given IV
    Other Names:
    • dFdCyd
    • Difluorodeoxycytidine Hydrochloride
    • Gemzar
    • LY-188011
    • LY188011
  • Radiation: Intensity-Modulated Radiation Therapy
    Undergo IMRT
    Other Names:
    • IMRT
    • Intensity Modulated RT
    • Intensity-Modulated Radiotherapy
  • Procedure: Therapeutic Conventional Surgery
    Undergo local core biopsy or surgical excision
Study Arms  ICMJE Experimental: Treatment (IMRT, gemcitabine, cisplatin, surgery)
Patients undergo IMRT 5 days a week for 6 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 60 minutes weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after completion of chemoradiation patients undergo local core biopsy to confirm response or surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes.
Interventions:
  • Drug: Cisplatin
  • Drug: Gemcitabine Hydrochloride
  • Radiation: Intensity-Modulated Radiation Therapy
  • Procedure: Therapeutic Conventional Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 8, 2012)
52
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with locally advanced, previously untreated squamous cell carcinoma of the vulva
  • Patients with T2 or T3 primary tumors (N0-3, M0) not amenable to surgical resection by standard radical vulvectomy
  • Absolute neutrophil count (ANC) >= 1,500/mcl
  • Platelets >= 100,000/mcl
  • Creatinine =< 1.5 times institutional upper limit of normal (ULN) OR calculated creatinine clearance >= 60 mL/min
  • Bilirubin =< 1.5 x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN
  • Alkaline phosphatase =< 3 x ULN
  • Patients judged capable of tolerating a radical course of chemoradiation therapy
  • Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III protocol or Rare Tumor protocol for the same patient population
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients with a GOG performance status of 0, 1, or 2

Exclusion Criteria:

  • Patients with recurrent carcinoma of the vulva regardless of previous treatment
  • Patients who have received prior pelvic radiation or cytotoxic chemotherapy
  • Patients with vulvar melanomas or sarcomas
  • Patients with circumstances that will not permit completion of the study or the required follow-up
  • Patients with evidence of active septicemia, severe infection, gastrointestinal bleeding or severe gastrointestinal symptoms requiring medical or surgical therapy
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01595061
Other Study ID Numbers  ICMJE GOG-0279
NCI-2012-01964 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000732793
GOG-0279 ( Other Identifier: NRG Oncology )
GOG-0279 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gynecologic Oncology Group
Study Sponsor  ICMJE Gynecologic Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Neil S Horowitz NRG Oncology
PRS Account Gynecologic Oncology Group
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP