Trial · NCT01595061

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

NCT01595061, Phase 2, Unknown, Gynecologic Oncology Group; results first posted 2021-12-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva. Trials, record NCT01595061. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01595061

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva
NCT number: NCT01595061
Status: Unknown
Phases: Phase 2
Enrollment: 57 participants, actual
Lead sponsor: Gynecologic Oncology Group
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
Interventions: Cisplatin, Gemcitabine Hydrochloride, Intensity-Modulated Radiation Therapy, Therapeutic Conventional Surgery
First posted: 2012-05-09
Last updated: 2021-12-29
Results first posted: 2021-12-29

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Complete Pathologic Response	6 -8 weeks after completion of chemo-radiation	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.
Secondary	Complete Clinical Response	6-8 weeks after completion of chemo-radiation	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.
Secondary	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.	Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
Secondary	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	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

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Complete Pathologic Response	6 -8 weeks after completion of chemo-radiation	Eligible and treated	percentage of participants	NUMBER
SECONDARY	Complete Clinical Response	6-8 weeks after completion of chemo-radiation	Eligible and Treated	percentage of participants	NUMBER
SECONDARY	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.	Eligible and Treated	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	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	Eligible and treated	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Complete Pathologic Response	GEM+CIS+IMRT		73.6	90% Confidence Interval 64 to 100	percentage of participants
Complete Clinical Response	GEM+CIS+IMRT		71.7	90% Confidence Interval 60 to 82	percentage of participants
Adverse Events (Grade 3 or Higher) During Treatment Period	GEM+CIS+IMRT	Leukopenia	27		Participants
Adverse Events (Grade 3 or Higher) During Treatment Period	GEM+CIS+IMRT	Thrombocytopenia	20		Participants
Adverse Events (Grade 3 or Higher) During Treatment Period	GEM+CIS+IMRT	Neutropenia	20		Participants
Adverse Events (Grade 3 or Higher) During Treatment Period	GEM+CIS+IMRT	Anemia	20		Participants
Adverse Events (Grade 3 or Higher) During Treatment Period	GEM+CIS+IMRT	Other Investigations	7		Participants
Adverse Events (Grade 3 or Higher) During Treatment Period	GEM+CIS+IMRT	Other blood and lymphatic disorders	8		Participants
Adverse Events (Grade 3 or Higher) During Treatment Period	GEM+CIS+IMRT	Cardiac disorders	2		Participants
Adverse Events (Grade 3 or Higher) During Treatment Period	GEM+CIS+IMRT	Gastrointestinal disorders	10		Participants

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	GEM+CIS+IMRT	57
Overall Study	COMPLETED	GEM+CIS+IMRT	53
Overall Study	NOT COMPLETED	GEM+CIS+IMRT	4

Source ClinicalTrials.gov

Adverse events166

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Blood And Lymphatic System Disorders - Other	Blood and lymphatic system disorders	GEM+CIS+IMRT	9	53
other	Anemia	Blood and lymphatic system disorders	GEM+CIS+IMRT	42	53
other	Febrile Neutropenia	Blood and lymphatic system disorders	GEM+CIS+IMRT	3	53
other	Atrial Fibrillation	Cardiac disorders	GEM+CIS+IMRT	2	53
other	Mobitz Type I	Cardiac disorders	GEM+CIS+IMRT	1	53
other	Supraventricular Tachycardia	Cardiac disorders	GEM+CIS+IMRT	1	53
other	Sinus Bradycardia	Cardiac disorders	GEM+CIS+IMRT	2	53
other	Palpitations	Cardiac disorders	GEM+CIS+IMRT	3	53
other	Sinus Tachycardia	Cardiac disorders	GEM+CIS+IMRT	5	53
other	Chest Pain - Cardiac	Cardiac disorders	GEM+CIS+IMRT	1	53

1 to 10 of 166Source ClinicalTrials.gov

See all 166 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GEM+CIS+IMRT	1	53
Total, other adverse events	GEM+CIS+IMRT	53	53
Total, serious adverse events	GEM+CIS+IMRT	24	53

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38574312	DERIVED

Source PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180868	NRG Oncology Network Group Operations Center	WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S.	NRG ONCOLOGY FOUNDATION, INC.	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA027469	Gynecologic Oncology Group	DISAIA, PHILIP J.	GYNECOLOGIC ONCOLOGY GROUP	NATIONAL CANCER INSTITUTE	1985 to 2013	NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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