Stage III Vulvar CancerPhase 2NCT00068406

Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva

A Phase 2 study testing 3-Dimensional Conformal Radiation Therapy, Cisplatin and Conventional Surgery in people with Stage III Vulvar Cancer and Stage IVB Vulvar Cancer, run by Gynecologic Oncology Group at 103 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Any age, women only
Conditions the study is for: Stage III Vulvar Cancer, Stage IVB Vulvar Cancer, Vulvar Squamous Cell Carcinoma
What is being tested?: 3-Dimensional Conformal Radiation Therapy, Cisplatin and Conventional Surgery
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 103 sitesUnited States
Study dates: Jan 2005to 20 Jan 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Diagnosis of locally advanced squamous cell carcinoma of the vulva
T3 or T4 (N0-3, M0)
Not amenable to surgical resection by standard radical vulvectomy
Previously untreated disease
No recurrent disease
No vulvar melanoma or sarcoma

Show all 24Show fewer

Performance status - GOG 0-3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Bilirubin no greater than 1.5 times normal
Alkaline phosphatase no greater than 3 times normal
SGOT no greater than 3 times normal
Creatinine no greater than 2.0 mg/dL
No gastrointestinal bleeding
No severe gastrointestinal symptoms
Capable of tolerating a radical course of chemoradiotherapy
No septicemia
No severe infection
No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
No circumstance that would preclude study completion or follow-up
No prior cytotoxic chemotherapy
No prior pelvic radiotherapy
No concurrent boost brachytherapy
No prior anticancer therapy that would contraindicate study therapy

Who cannot join

None listed.

Trial locations and contacts

103 sites in 1 country.

City, postcode or hospital

103 sites in 1 country

United States103 sites

Abington Memorial Hospital
Abington, Pennsylvania, 19001
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106
Colorado Gynecologic Oncology Group
Aurora, Colorado, 80010
Rush - Copley Medical Center
Aurora, Illinois, 60504
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237
Woman's Hospital
Baton Rouge, Louisiana, 70817
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
University of Illinois
Chicago, Illinois, 60612
University of Cincinnati
Cincinnati, Ohio, 45267
Case Western Reserve University
Cleveland, Ohio, 44106
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Riverside Methodist Hospital
Columbus, Ohio, 43214
Mount Carmel Health Center West
Columbus, Ohio, 43222
Beaumont Hospital-Dearborn
Dearborn, Michigan, 48124
Decatur Memorial Hospital
Decatur, Illinois, 62526
Saint John Hospital and Medical Center
Detroit, Michigan, 48236
Elkhart General Hospital
Elkhart, Indiana, 46515
Hurley Medical Center
Flint, Michigan, 48502
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532
University of Texas Medical Branch
Galveston, Texas, 77555-0565
Banner Thunderbird Medical Center
Glendale, Arizona, 85306
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
Spectrum Health-Blodgett Campus
Grand Rapids, Michigan, 49506
Gynecologic Oncology of West Michigan PLLC
Grand Rapids, Michigan, 49546
North Colorado Medical Center
Greeley, Colorado, 80631
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526
Saint Vincent Hospital
Green Bay, Wisconsin, 54301
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, 54303
Saint Mary's Hospital
Green Bay, Wisconsin, 54303
Hartford Hospital
Hartford, Connecticut, 06102
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Centerpoint Medical Center LLC
Independence, Missouri, 64057
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Gynecologic Oncology of Indiana
Indianapolis, Indiana, 46237
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Allegiance Health
Jackson, Michigan, 49201
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, 60435
Mercy Hospital-Joplin
Joplin, Missouri, 64804
Providence Medical Center
Kansas City, Kansas, 66112
Radiation Oncology Practice Corporation South
Kansas City, Missouri, 64114
Radiation Oncology Practice Corporation - North
Kansas City, Missouri, 64154
Knoxville Gynecologic Cancer Specialists PC
Knoxville, Tennessee, 37920
Community Howard Regional Health
Kokomo, Indiana, 46904
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
IU Health La Porte Hospital
La Porte, Indiana, 46350
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Sparrow Hospital
Lansing, Michigan, 48912
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Saint Mary Mercy Hospital
Livonia, Michigan, 48154
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
McKee Medical Center
Loveland, Colorado, 80539
Central Georgia Gynecologic Oncology
Macon, Georgia, 31201
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Lake University Ireland Cancer Center
Mentor, Ohio, 44060
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, 46360
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545
Cottonwood Hospital Medical Center
Murray, Utah, 84107
The Hospital of Central Connecticut
New Britain, Connecticut, 06050
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Yale University
New Haven, Connecticut, 06520
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 68198
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
UF Cancer Center at Orlando Health
Orlando, Florida, 32806
Radiation Oncology Practice Corporation Southwest
Overland Park, Kansas, 66210
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006
Western Regional CCOP
Phoenix, Arizona, 85006
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341
Saint Joseph Mercy Port Huron
Port Huron, Michigan, 48060
Women and Infants Hospital
Providence, Rhode Island, 02905
Black Hills Obstetrics and Gynecology
Rapid City, South Dakota, 57701
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, 24016
Mayo Clinic
Rochester, Minnesota, 55905
Saint Mary's of Michigan
Saginaw, Michigan, 48601
Lakeland Hospital
Saint Joseph, Michigan, 49085
Memorial University Medical Center
Savannah, Georgia, 31404
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
University of Washington Medical Center
Seattle, Washington, 98195
Memorial Hospital of South Bend
South Bend, Indiana, 46601
South Bend Clinic
South Bend, Indiana, 46617
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628
Memorial Medical Center
Springfield, Illinois, 62781
Baystate Medical Center
Springfield, Massachusetts, 01199
Washington University School of Medicine
St Louis, Missouri, 63110
Stony Brook University Medical Center
Stony Brook, New York, 11794
Northwest Medical Specialties PLLC
Tacoma, Washington, 98405
Cancer Care Associates-Midtown
Tulsa, Oklahoma, 74104
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146
Carle Clinic-Urbana Main
Urbana, Illinois, 61801
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093
Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Phase II Trial of Radiation Therapy and Weekly Cisplatin Chemotherapy for the Treatment of Locally-Advanced Squamous Cell Carcinoma of the Vulva

This phase II trial is studying how well giving radiation therapy together with cisplatin followed by surgery works in treating patients with locally advanced cancer of the vulva. Drugs used in chemotherapy such as cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery.

Read the detailed description

OBJECTIVES:

Determine the efficacy of radiotherapy and cisplatin, in terms of achieving a complete clinical and pathological response, in patients with locally advanced squamous cell carcinoma of the vulva that is not amenable to standard radical vulvectomy.

II. Determine the toxicity of this regimen followed by surgery in these patients.

OUTLINE: This is a multicenter study.

Patients undergo radiotherapy daily on days 1-5 and receive concurrent cisplatin IV over 30 minutes on day 1. Treatment repeats weekly for approximately 6.5 weeks (a total of 32 fractions of radiotherapy) in the absence of unacceptable toxicity.

Six to eight weeks after the completion of chemoradiotherapy, patients with a complete clinical response may undergo incisional biopsy of the primary tumor and bilateral inguinal/femoral nodes (if the groin nodes were initially unresectable). Patients with microscopic or gross resectable residual disease may then undergo radical resection of the residual tumor. Patients with unresectable disease after the completion of chemoradiotherapy receive additional radiotherapy with 1-2 courses of concurrent cisplatin.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Conditions: Stage III Vulvar Cancer, Stage IVB Vulvar Cancer, Vulvar Squamous Cell Carcinoma
Being tested: 3-Dimensional Conformal Radiation Therapy, Cisplatin, Conventional Surgery
Medical subject headings: Vulvar Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3-Dimensional Conformal Radiation TherapyRadiation
Also called 3-dimensional radiation therapy, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D-CRT
CisplatinDrug
Also called Abiplatin, Blastolem, Briplatin, CDDP
Given IV
Conventional SurgeryProcedure or surgery

Study groups in NCT00068406
Study group	Role	What they receive
Treatment (conventional surgery, radiation therapy, cisplatin)	Experimental	Patients undergo radiotherapy daily on days 1-5 and receive concurrent cisplatin IV over 30 minutes on day 1. Treatment repeats weekly for approximately 6.5 weeks (a total of 32 fractions of radiotherapy) in the absence of unacceptable toxicity. Six to eight weeks after the completion of chemoradiotherapy, patients with a complete clinical response may undergo incisional biopsy of the primary tumor and bilateral inguinal/femoral nodes (if the groin nodes were initially unresectable). Patients with microscopic or gross resectable residual disease may then undergo radical resection of the residual tumor. Patients with unresectable disease after the completion of chemoradiotherapy receive additional radiotherapy with 1-2 courses of concurrent cisplatin. Receives: Radiation: 3-Dimensional Conformal Radiation Therapy; Drug: Cisplatin; Procedure: Conventional Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Complete Clinical and Pathologic Response
Complete clinical and pathologic response is defined as the disappearance of all gross tumor during chemoradiation with no residual tumor present in the surgical specimen.
Measured: Seven weeks after initiating treatment for clinical response and up to fifteen weeks for assessment of pathologic response.
Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period
Number of participants with a maximum grade of 3 or higher during the treatment period. Adverse events are graded and categorized using Common Terminology Criteria for Adverse Events Version 2.0
Measured: Assessed every cycle while on treatment, 30 days after the last cycle of treatment. Up to eleven weeks from the start of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 200520 Jan 2012

First posted11 Sep 2003 (estimated)
Study startJan 2005
Primary completionDec 2010
Study completion20 Jan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Stage III Vulvar CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00068406
Sponsor's protocol ID: GOG-0205
Other IDs: NCI-2009-00582, CDR0000322259, GOG-0205, GOG-0205, U10CA027469
Status last verified: Oct 2011
First submitted: 10 Sep 2003
Last updated: 20 Nov 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery
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Not yet recruitingPhase 3
A Phase III Randomised Clinical Trial of Ultrasound Groin Monitoring Versus Groin Lymph Node Dissection to De-Escalate the Extent of Surgery in Vulvar Cancer
Vulvar Cancer Stage I, Vulvar Cancer Stage II

All Stage III Vulvar Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Trial of Radiation Therapy and Weekly Cisplatin Chemotherapy for the Treatment of Locally-Advanced Squamous Cell Carcinoma of the Vulva
ClinicalTrials.gov ID: NCT00068406
Acronym / sponsor ID: GOG-0205
Conditions: Stage III Vulvar Cancer, Stage IVB Vulvar Cancer, Vulvar Squamous Cell Carcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Gynecologic Oncology GroupResearch network
Collaborators: National Cancer Institute (NCI)
Study start: Jan 2005
Primary completion: Dec 2010 (actual)
Study completion: 20 Jan 2012 (actual)
First posted: 11 Sep 2003 (estimated)
Results: Posted 17 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OBJECTIVES:

Determine the efficacy of radiotherapy and cisplatin, in terms of achieving a complete clinical and pathological response, in patients with locally advanced squamous cell carcinoma of the vulva that is not amenable to standard radical vulvectomy.

II. Determine the toxicity of this regimen followed by surgery in these patients.

OUTLINE: This is a multicenter study.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (conventional surgery, radiation therapy, cisplatin)	Experimental	Radiation: 3-Dimensional Conformal Radiation Therapy, Drug: Cisplatin, Procedure: Conventional SurgeryPatients undergo radiotherapy daily on days 1-5 and receive concurrent cisplatin IV over 30 minutes on day 1. Treatment repeats weekly for approximately 6.5 weeks (a total of 32 fractions of radiotherapy) in the absence of unacceptable toxicity. Six to eight weeks after the completion of chemoradiotherapy, patients with a complete clinical response may undergo incisional biopsy of the primary tumor and bilateral inguinal/femoral nodes (if the groin nodes were initially unresectable). Patients with microscopic or gross resectable residual disease may then undergo radical resection of the residual tumor. Patients with unresectable disease after the completion of chemoradiotherapy receive additional radiotherapy with 1-2 courses of concurrent cisplatin.

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (24 listed)

Diagnosis of locally advanced squamous cell carcinoma of the vulva
Not amenable to surgical resection by standard radical vulvectomy
Previously untreated disease
No recurrent disease
No vulvar melanoma or sarcoma

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
3-Dimensional Conformal Radiation TherapyAlso: 3-dimensional radiation therapy, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D-CRT	Radiation	Treatment (conventional surgery, radiation therapy, cisplatin)
CisplatinAlso: Abiplatin, Blastolem, Briplatin, CDDPGiven IV	Drug	Treatment (conventional surgery, radiation therapy, cisplatin)
Conventional Surgery	Procedure or surgery	Treatment (conventional surgery, radiation therapy, cisplatin)

Primary outcome

Complete Clinical and Pathologic Response
Time frame: Seven weeks after initiating treatment for clinical response and up to fifteen weeks for assessment of pathologic response.
Complete clinical and pathologic response is defined as the disappearance of all gross tumor during chemoradiation with no residual tumor present in the surgical specimen.
Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period
Time frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment. Up to eleven weeks from the start of study treatment
Number of participants with a maximum grade of 3 or higher during the treatment period. Adverse events are graded and categorized using Common Terminology Criteria for Adverse Events Version 2.0

Results and safety

Results posted to the registry on 17 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cisplatin + Radiation, Then Surgery	61	58

Primary outcome: Complete Clinical and Pathologic Response

Time frame: Seven weeks after initiating treatment for clinical response and up to fifteen weeks for assessment of pathologic response.. Number (90% Confidence Interval). Unit: Percentage of Participants

Measure	Cisplatin + Radiation, Then Surgery n = 58
Value	50 (39 to 61)

Population analysed: Eligible and treated patients

Primary outcome: Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period

Time frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment. Up to eleven weeks from the start of study treatment. Count of participants. Unit: Participants

Measure	Cisplatin + Radiation, Then Surgery n = 58
Leukopenia	18
Anemia	4
Thrombocytopenia	3
Neutropenia	11
Other Hematologic	13
Constitutional	5
Cardiovascular	4
Dermatologic	17

Population analysed: Eligible and treated patients

Adverse events

Time frame: SAE (Serious Adverse Events): All adverse events occurring during study chemo radiation treatment period and up to 30 days after stopping the study treatment are reported without regard to attribution. Up to eleven weeks from the start of study treatment. OAE(Other Adverse Events): All treatment-related adverse events occurring during study chemo radiation treatment period and up to 30 days after stopping the study treatment are reported. Up to eleven weeks from the start of study treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cisplatin + Radiation, Then Surgery	17 of 58 (29.3%)	58 of 58 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Stage III Vulvar Cancer

Active, not recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Moore principal investigator

Gynecologic Oncology Group

103 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Clinical and Pathologic Response (time frame: Seven weeks after initiating treatment for clinical response and up to fifteen weeks for assessment of pathologic response.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00068406.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.