NCT01595061 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: UNKNOWN
Registry last update: 2021-12-29

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Complete Pathologic Response

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outcome · POSTED

Complete Clinical Response

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outcome · POSTED

Adverse Events (Grade 3 or Higher) During Treatment Period

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outcome · POSTED

Progression-free Survival (PFS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Drug: Cisplatin
Drug: Gemcitabine Hydrochloride
Radiation: Intensity-Modulated Radiation Therapy
Procedure: Therapeutic Conventional Surgery
label
Treatment (IMRT, gemcitabine, cisplatin, surgery)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (IMRT, gemcitabine, cisplatin, surgery)
description
Given IV
name
Cisplatin
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
type
DRUG
arm Group Labels
Treatment (IMRT, gemcitabine, cisplatin, surgery)
description
Given IV
name
Gemcitabine Hydrochloride
other Names
dFdCyd
Difluorodeoxycytidine Hydrochloride
FF 10832
FF-10832
FF10832
Gemcitabine HCI
Gemzar
LY-188011
LY188011
type
DRUG
arm Group Labels
Treatment (IMRT, gemcitabine, cisplatin, surgery)
description
Undergo IMRT
name
Intensity-Modulated Radiation Therapy
other Names
IMRT
Intensity Modulated RT
Intensity-Modulated Radiotherapy
Radiation, Intensity-Modulated Radiotherapy
type
RADIATION
arm Group Labels
Treatment (IMRT, gemcitabine, cisplatin, surgery)
description
Undergo local core biopsy or surgical excision
name
Therapeutic Conventional Surgery
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 57
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Percentage of participants with complete pathologic response. Complete pathologic response is defined as negative local core biopsy or FNA specimens following primary chemo-radiation therapy.
measure
Complete Pathologic Response
time Frame
6 -8 weeks after completion of chemo-radiation

secondary Outcomes

description
Percentage of participants with complete clinical response. Complete clinical response is defined as no clinical/radiographic evidence of primary disease (vulva or groin) following primary chemo-radiation therapy.
measure
Complete Clinical Response
time Frame
6-8 weeks after completion of chemo-radiation
description
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
measure
Adverse Events (Grade 3 or Higher) During Treatment Period
time Frame
During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
description
Estimate for probability of progression free survival by Kaplan-Meier method, where progression-free survival is defined as the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. PFS is censored in patients who are alive and have not progressed. Progression is assessed by RECIST 1.1
measure
Progression-free Survival (PFS)
time Frame
From study entry to disease progression, death or date of last contact, whichever occurs first. The median for observed PFS was 26.2 month with a range from 1.5 months to 82.4 months

Full study description

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.

Source references

references

citation
Horowitz NS, Deng W, Peterson I, Mannel RS, Thompson S, Lokich E, Myers T, Hanjani P, O'Malley DM, Chung KY, Miller DS, Ueland FR, Dizon DS, Miller A, Mayadev JS, Leath CA 3rd, Monk BJ. Phase II Trial of Cisplatin, Gemcitabine, and Intensity-Modulated Radiation Therapy for Locally Advanced Vulvar Squamous Cell Carcinoma: NRG Oncology/GOG Study 279. J Clin Oncol. 2024 Jun 1;42(16):1914-1921. doi: 10.1200/JCO.23.02235. Epub 2024 Apr 4.
pmid
38574312
type
DERIVED

Source notices and limitations

Discovery and provenance

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edge id
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requested nct id
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primary nct id
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source kind
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https://clinicaltrials.gov/api/v2/studies?query.cond=Vulvar+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
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nct id
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occurrences
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exact text
NCT01595061
start
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offset unit
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query cond
Vulvar Cancer
query disease state id
ds-vulvar-cancer
source file
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source kind
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Vulvar+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice