Trial · NCT05905315
Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC
NCT05905315, Phase 2, Recruiting, The Netherlands Cancer Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC. Trials, record NCT05905315. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05905315
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC
- NCT number
- NCT05905315
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 98 participants, estimated
- Lead sponsor
- The Netherlands Cancer Institute
- Conditions
- Locally Advanced Vulvar Carcinoma, Squamous Cell Carcinoma of the Vulva
- Interventions
- Paclitaxel and Carboplatin, Chemoradiation
- First posted
- 2023-06-15
- Last updated
- 2024-04-15
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Loco-regional control after 24 months per completed treatment including salvage treatment | 24 months after completed treatment | Proportion of patients free from local-regional progression |
| Secondary | Disease-related treatment failure | 24 months after completed treatment | Patients without an event will be censored at their last date of contact. The Kaplan-Meier method will be used to estimate freedom from disease-related failure. Difference between the two main treatment arms, NACT vs. chemotherapy, will be tested using a log-rank test. Incidences of disease-related failure will be reported based on the Kaplan-Meier estimates, together with confidence intervals for the hazard ratio using both 90 and 95% confidence levels. |
| Secondary | Disease free survival | 24 months after completed treatment | |
| Secondary | Patterns of recurrence of disease | 24 months after completed treatment | Type of recurrence after treatment: local, regional or distant recurrence |
| Secondary | Overall survival | 24 months after completed treatment | |
| Secondary | Treatment related death | 24 months after completed treatment | |
| Secondary | Prevention of trimodal treatment | 24 months after completed treatment | Proportion of patients that don't need adjuvant surgery (arm 1) and number of patients that don't need adjuvant radiotherapy (arm 2) |
| Secondary | Functional organ preservation | 24 months after completed treatment | Proportion of patients for who an organ-sparing surgery is possible |
| Secondary | Short term and long term complications | 24 months after completed treatment | According to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38719277 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
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.
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/NCT05905315
GET https://conductscience.org/api/trials/v1/NCT05905315/registered