NCT00068406 · STUDY IN CONTEXT

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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Eligible and treated patients

→

primary · POSTED

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

Eligible and treated patients

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-vulvar-cancer
nct id: NCT00068406
trial label: Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 2
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-vulvar-cancer
nct id
NCT00068406
outcome key
om-0000
source section id
NCT00068406-om-0000
source outcome index
0
endpoint
Complete Clinical and Pathologic Response
endpoint definition
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.
time origin
Seven weeks after initiating treatment for clinical response and up to fifteen weeks for assessment of pathologic response.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and treated patients
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-vulvar-cancer
nct id
NCT00068406
outcome key
om-0001
source section id
NCT00068406-om-0001
source outcome index
1
endpoint
Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period
endpoint definition
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
time origin
Assessed every cycle while on treatment, 30 days after the last cycle of treatment. Up to eleven weeks from the start of study treatment
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and treated patients
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-vulvar-cancer
nct id
NCT00068406
outcome key
om-0000
arm key
OG000
arm label
Cisplatin + Radiation, Then Surgery
regimen
Radiation therapy to the vulva, inguinal-femoral, and lower pelvic lymph nodes by AP-PA fields (180 cGy/daily fraction X 5 days, repeated weekly to a total of 32 fractions- total dose 5760 Gy). Concurrent cisplatin (40 mg/m2) chemotherapy administered weekly throughout radiation therapy. Six to eight weeks following the completion of chemoradiation - surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes (if the inguinal-femoral nodes were considered unresectable prior to chemoradiation).
analyzed count
58
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00068406-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-vulvar-cancer
nct id
NCT00068406
outcome key
om-0001
arm key
OG000
arm label
Cisplatin + Radiation, Then Surgery
regimen
Radiation therapy to the vulva, inguinal-femoral, and lower pelvic lymph nodes by AP-PA fields (180 cGy/daily fraction X 5 days, repeated weekly to a total of 32 fractions- total dose 5760 Gy). Concurrent cisplatin (40 mg/m2) chemotherapy administered weekly throughout radiation therapy. Six to eight weeks following the completion of chemoradiation - surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes (if the inguinal-femoral nodes were considered unresectable prior to chemoradiation).
analyzed count
58
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00068406-om-0001#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-vulvar-cancer
nct id
NCT00068406
harm key
EG000
source section id
NCT00068406-ae
event group key
EG000
event group label
Cisplatin + Radiation, Then Surgery
serious affected
17
serious at risk
58
other affected
58
other at risk
58
frequency threshold
0
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice