Trial · NCT02275286
Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients
NCT02275286, Phase 1, Phase 2, Recruiting, Grupo Espanol de Investigacion en Sarcomas
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients. Trials, record NCT02275286. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02275286
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients
- NCT number
- NCT02275286
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 199 participants, estimated
- Lead sponsor
- Grupo Espanol de Investigacion en Sarcomas
- Conditions
- Liposarcoma, Myxoid, Sarcoma, Soft Tissue, Leiomyosarcoma, Liposarcoma, Pleomorphic Liposarcoma
- Interventions
- Trabectedin, Radiotherapy
- First posted
- 2014-10-27
- Last updated
- 2023-05-31
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
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.
Papers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT02275286
GET https://conductscience.org/api/trials/v1/NCT02275286/registered