Trial · NCT01543802
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Metabolic response rate | day 22-28 (time of post-treatment PET-CT) | Metabolic response rate is defined as the proportion of patients achieving a metabolic response, i.e. a 50% reduction of the mean standardized uptake value (SUVmean) in the post-treatment compared to the pre-treatment FDG-PET-CT |
| Secondary | Percentage of tumor tissue with regressive alterations upon resection ("Histopathological Response") | day 28-35 | |
| Secondary | Decrease in tumor size in MRI according to RECIST 1.1 criteria | baseline and day 22-28 | |
| Secondary | Change of FDG influx as well as of transport rates k1-k4 and distribution volume VB and fractal dimension in dynamic PET-CT ("Dynamic PET-CT Response") | baseline and day 22-28 | Absolute values of all parameters of FDG kinetics will be used for discriminant analysis evaluation. |
| Secondary | Number of days for which planned resection is delayed after treatment | day 28-35 | |
| Secondary | Number of patients in which adverse events occur during treatment | day 1-21 | Adverse events are graded according to NCI Common Terminology Criteria for Adverse Events v4.0 (NCI CTCAE v4) |
| Secondary | Disease-free survival | 3 years | |
| Secondary | Local recurrence-free survival | 3 years | |
| Secondary | Distant recurrence-free survival | 3 years | |
| Secondary | Overall survival | 3 years | |
| Secondary | Decrease in vascularisation in MRI according to adapted Choi Criteria | baseline and day 22-28 | Adapted Choi Criteria as defined ín Stacchiotti S, Collini P, Messina A, Morosi C, Barisella M, Bertulli R, et al. High-grade soft-tissue sarcomas: tumor response assessment--pilot study to assess the correlation between radiologic and pathologic response by using RECIST and Choi criteria. Radiology 2009;251(2):447-56. |
| Secondary | Decrease in MRI apparent diffusion coefficient (ADC) values | baseline and day 22-28 | ADC values as defined by Dudeck O, Zeile M, Pink D, Pech M, Tunn PU, Reichardt P, et al. Diffusion-weighted magnetic resonance imaging allows monitoring of anticancer treatment effects in patients with soft-tissue sarcomas. J Magn Reson Imaging 2008;27(5):1109-13. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01543802/registered