TriangleNCT01595061 · STUDY IN CONTEXT
Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell 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
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.
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.
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
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
Reported safety
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
- NCT01595061
- trial label
- Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell 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
- 4
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer
- nct id
- NCT01595061
- outcome key
- om-0000
- source section id
- NCT01595061-om-0000
- source outcome index
- 0
- endpoint
- Complete Pathologic Response
- endpoint definition
- 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.
- time origin
- 6 -8 weeks after completion of chemo-radiation
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and treated
- 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
- NCT01595061
- outcome key
- om-0001
- source section id
- NCT01595061-om-0001
- source outcome index
- 1
- endpoint
- Complete Clinical Response
- endpoint definition
- 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.
- time origin
- 6-8 weeks after completion of chemo-radiation
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and Treated
- 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
- NCT01595061
- outcome key
- om-0002
- source section id
- NCT01595061-om-0002
- source outcome index
- 2
- endpoint
- Adverse Events (Grade 3 or Higher) During Treatment Period
- endpoint definition
- Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
- time origin
- 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.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and Treated
- 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
- NCT01595061
- outcome key
- om-0003
- source section id
- NCT01595061-om-0003
- source outcome index
- 3
- endpoint
- Progression-free Survival (PFS)
- endpoint definition
- 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
- time origin
- 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
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and treated
- 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
- NCT01595061
- outcome key
- om-0000
- arm key
- OG000
- arm label
- GEM+CIS+IMRT
- regimen
- Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
- analyzed count
- 53
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01595061-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer
- nct id
- NCT01595061
- outcome key
- om-0001
- arm key
- OG000
- arm label
- GEM+CIS+IMRT
- regimen
- Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
- analyzed count
- 53
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01595061-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer
- nct id
- NCT01595061
- outcome key
- om-0002
- arm key
- OG000
- arm label
- GEM+CIS+IMRT
- regimen
- Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
- analyzed count
- 53
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01595061-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer
- nct id
- NCT01595061
- outcome key
- om-0003
- arm key
- OG000
- arm label
- GEM+CIS+IMRT
- regimen
- Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
- analyzed count
- 53
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01595061-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-vulvar-cancer
- nct id
- NCT01595061
- harm key
- EG000
- source section id
- NCT01595061-ae
- event group key
- EG000
- event group label
- GEM+CIS+IMRT
- serious affected
- 24
- serious at risk
- 53
- other affected
- 53
- other at risk
- 53
- frequency threshold
- 0
- collection 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.
- 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