Trial · NCT00068406

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

NCT00068406, Phase 2, Completed, Gynecologic Oncology Group; results first posted 2017-10-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva. Trials, record NCT00068406. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00068406

On this page

Trial

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

Title: Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva
NCT number: NCT00068406
Status: Completed
Phases: Phase 2
Enrollment: 61 participants, actual
Lead sponsor: Gynecologic Oncology Group
Conditions: Stage III Vulvar Cancer, Stage IVB Vulvar Cancer, Vulvar Squamous Cell Carcinoma
Interventions: 3-Dimensional Conformal Radiation Therapy, Cisplatin, Conventional Surgery
First posted: 2003-09-11
Last updated: 2017-11-20
Results first posted: 2017-10-17

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Complete Clinical and Pathologic Response	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.
Primary	Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period	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

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Complete Clinical and Pathologic Response	Seven weeks after initiating treatment for clinical response and up to fifteen weeks for assessment of pathologic response.	Eligible and treated patients	Percentage of Participants	NUMBER
PRIMARY	Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period	Assessed every cycle while on treatment, 30 days after the last cycle of treatment. Up to eleven weeks from the start of study treatment	Eligible and treated patients	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group18

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

Outcome	Group	Category	Value	Spread	Units
Complete Clinical and Pathologic Response	Cisplatin + Radiation, Then Surgery		50	90% Confidence Interval 39 to 61	Percentage of Participants
Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period	Cisplatin + Radiation, Then Surgery	Leukopenia	18		Participants
Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period	Cisplatin + Radiation, Then Surgery	Anemia	4		Participants
Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period	Cisplatin + Radiation, Then Surgery	Thrombocytopenia	3		Participants
Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period	Cisplatin + Radiation, Then Surgery	Neutropenia	11		Participants
Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period	Cisplatin + Radiation, Then Surgery	Other Hematologic	13		Participants
Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period	Cisplatin + Radiation, Then Surgery	Constitutional	5		Participants
Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period	Cisplatin + Radiation, Then Surgery	Cardiovascular	4		Participants
Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period	Cisplatin + Radiation, Then Surgery	Dermatologic	17		Participants
Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period	Cisplatin + Radiation, Then Surgery	Gastrointestinal	13		Participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Cisplatin + Radiation, Then Surgery	61
Overall Study	COMPLETED	Cisplatin + Radiation, Then Surgery	58
Overall Study	NOT COMPLETED	Cisplatin + Radiation, Then Surgery	3

Source ClinicalTrials.gov

Adverse events55

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	Leukopenia	Blood and lymphatic system disorders	Cisplatin + Radiation, Then Surgery	42	58
other	Anemia	Blood and lymphatic system disorders	Cisplatin + Radiation, Then Surgery	51	58
other	Thrombocytopenia	Blood and lymphatic system disorders	Cisplatin + Radiation, Then Surgery	30	58
other	Neutropenia	Blood and lymphatic system disorders	Cisplatin + Radiation, Then Surgery	28	58
other	Otherhematologic	Blood and lymphatic system disorders	Cisplatin + Radiation, Then Surgery	13	58
other	Lymphatics	Blood and lymphatic system disorders	Cisplatin + Radiation, Then Surgery	2	58
other	Cardiovascular	Cardiac disorders	Cisplatin + Radiation, Then Surgery	10	58
other	Hearing	Ear and labyrinth disorders	Cisplatin + Radiation, Then Surgery	3	58
other	Endocrine	Endocrine disorders	Cisplatin + Radiation, Then Surgery	8	58
other	Ocular	Eye disorders	Cisplatin + Radiation, Then Surgery	1	58

1 to 10 of 55Source ClinicalTrials.gov

See all 55 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cisplatin + Radiation, Then Surgery
Total, other adverse events	Cisplatin + Radiation, Then Surgery	58	58
Total, serious adverse events	Cisplatin + Radiation, Then Surgery	17	58

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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
U10CA027469	Gynecologic Oncology Group	DISAIA, PHILIP J.	GYNECOLOGIC ONCOLOGY GROUP	NATIONAL CANCER INSTITUTE	1985 to 2013

Source 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.

GET https://conductscience.org/api/trials/v1/NCT00068406

GET https://conductscience.org/api/trials/v1/NCT00068406/events?page=2

API reference For AI assistants