NCT01595061|UnknownPhase 2ResultsDMC

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

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)

Gynecologic Oncology Group ClinicalTrials.gov

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5 other identifiers

GOG-0279NCI-2012-01964CDR0000732793U10CA180868U10CA027469

Study Type

interventional

Target

Locations

1 country

Sites

193

Timeline

RegisteredMay 2012

StartedJul 2012

CompletionSep 2022

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Jul 2012

Longer than P75 for phase_2

Geographic Reach

1 country

193 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.2 years study duration

First Submitted

Initial submission to the registry

May 8, 2012

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 9, 2012

Completed

2 months until next milestone

Study Start

First participant enrolled

July 2, 2012

Completed

8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2020

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

December 29, 2021

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2022

Completed

Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

8.2 years

First QC Date

May 8, 2012

Results QC Date

November 2, 2021

Last Update Submit

December 1, 2021

Conditions

Stage III Vulvar Cancer AJCC v7 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

Outcome Measures

Primary Outcomes (1)

Complete Pathologic Response
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.
6 -8 weeks after completion of chemo-radiation

Secondary Outcomes (3)

Complete Clinical Response
6-8 weeks after completion of chemo-radiation
Adverse Events (Grade 3 or Higher) During Treatment Period
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.
Progression-free Survival (PFS)
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

Study Arms (1)

Treatment (IMRT, gemcitabine, cisplatin, surgery)

EXPERIMENTAL

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.

Drug: CisplatinDrug: Gemcitabine HydrochlorideRadiation: Intensity-Modulated Radiation TherapyProcedure: Therapeutic Conventional Surgery

Interventions

CisplatinDRUG

Given IV

Also known as: 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

Treatment (IMRT, gemcitabine, cisplatin, surgery)

Gemcitabine HydrochlorideDRUG

Given IV

Also known as: dFdCyd, Difluorodeoxycytidine Hydrochloride, FF 10832, FF-10832, FF10832, Gemcitabine HCI, Gemzar, LY-188011, LY188011

Treatment (IMRT, gemcitabine, cisplatin, surgery)

Intensity-Modulated Radiation TherapyRADIATION

Undergo IMRT

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

Treatment (IMRT, gemcitabine, cisplatin, surgery)

Therapeutic Conventional SurgeryPROCEDURE

Undergo local core biopsy or surgical excision

Treatment (IMRT, gemcitabine, cisplatin, surgery)

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Gynecologic Oncology Grouplead
National Cancer Institute (NCI)collaborator

Study Sites (193)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC