Trial · NCT02275286
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 | Tumor size | every 6 weeks for 24 months | Image tumor assessment: RECIST response for the combination of trabectedin plus radiation therapy in cohorts A and B. CHOI response for the combination of trabectedin plus radiation therapy in cohort C. |
| Primary | Relapse-free survival. | 5 years. | In cohort D to improve 5-year relapse-free survival (RFS), decreasing the 5-year relapse percentage from 30% to 10% in patients with well differentiated liposarcoma with cellular component and dedifferentiated G2 retroperitoneal resected liposarcoma (20% increase in RFS). |
| Secondary | Number and grade of adverse events | every 21 days until 30 days after last dose or during 25 months | CTCAE v4.03 adverse events registration to evaluate safety |
| Secondary | Number of months without progression | 24 months | Progression free survival (PFS) |
| Secondary | Number of months alive | 24 months | Overall survival (OS) |
| Secondary | Tumor size | every 6 weeks during 24 months (cohort A) or every 4months during 36 months (cohort B and C) | Image tumor assessment measured by Choi criteria. |
| Secondary | Questionnaire | every 3 months during 24 months | QLQ-C30 EORTC questionnaire to evaluate patient quality of life |
| Secondary | Overall response rate (ORR) | every 6 weeks during 24 months | Sum of complete responses, partial responses and stable diseases |
| Secondary | relapse free survival (RFS) at 3 years (cohorts C and D) | After 3 year since last patient treatment initiation | percentage of relapses from diagnosis at 3 years |
| Secondary | relapse at 5 years (cohorts C and D) | After 5 years since last patient treatment initiation | number of months without relapse from treatment initiation until 5 years. |
| Secondary | Tumor cells response to the treatment | Week 11, at surgery | Number of tumor necrotic cells |
| Secondary | Predictive and prognostic biomarker | Baseline and week 11 (at surgery) | percentage of protein and RNA expression of FAS, Ca2+ and NER pathways in tumor samples obtained at baseline and at surgery (approx week 11) |
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.
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