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NCT04780464: Tolerance
A 3 Arm Randomized Study on Health-related QoL of Elderly Patients With Advanced Soft Tissue Sarcoma
Phase 3 trial testing Doxorubicin in Advanced Soft-tissue Sarcoma in 14 participants. Terminated before completion.
22 September 2023
Quick facts
| Lead sponsor | European Organisation for Research and Treatment of Cancer - EORTC |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 11 April 2022 |
| Primary completion | 22 September 2023 |
| Estimated completion | 11 November 2023 |
| Sites | 2 locations across Jordan, Cyprus |
Drugs / interventions tested
- Doxorubicin (doxorubicin) — full drug profile →
- Doxorubicin (doxorubicin) — full drug profile →
- Cyclophosphamide Oral Product
- Prednisolone — full drug profile →
- Prednisone (prednisone) — full drug profile →
Conditions studied
- Advanced Soft-tissue Sarcoma — all drugs for Advanced Soft-tissue Sarcoma →
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC — full company profile →
Who can join
65 and older, any sex, with Advanced Soft-tissue Sarcoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multi-centre, open label, randomized phase 3 selection study (1:2:2 randomization). After confirmation of the eligibility criteria, 185 patients will be randomized 1:2:2 to either the control arm (doxorubicin 60-75 mg/m² IV every 3 weeks) or experimental arm 1 (doxorubicin 12 mg/m2 IV every week) or experimental arm 2 (cyclophosphamide 100 mg orally BD plus prednisolone 10-20 mg orally on day 1 to day 7 of each 14 day cycle). HRQoL assessment will be performed every 3 weeks during the first 12 weeks and every 12 weeks thereafter until month 12 after start of treatment. Disease evaluation will be performed every 12 weeks until progression. The primary endpoint of the study is difference among the study arms in physical and role functioning at 12 weeks.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Management and Outcomes of Older Patients (Age ≥ 70 Years) with Advanced Soft Tissue Sarcoma and Role of Geriatric Assessment and Oncological Multidimensional Prognostic Index (Onco-MPI) in a Real-World Setting.
Chiusole B, Tortorelli I, Galiano A, Murtas F, et al · · 2023 · cited 5× · PMID 36831386 · DOI 10.3390/cancers15041043
Verify or expand the search:
- PubMed search for NCT04780464
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
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Other recruiting trials for Advanced Soft-tissue Sarcoma
Currently open trials in the same condition.
- NCT06367075 — A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma · Phase 2 · recruiting
- NCT05876715 — LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma · Phase 1, PHASE2 · recruiting
- NCT05809830 — Phase I/II of LB-100 Plus Doxorubicin vs. Doxorubicin Alone in First Line of Advanced Soft Tissue Sarcomas · Phase 1, PHASE2 · active not recruiting
- NCT05620693 — Study of NY-ESO-1 TCR-T in Advanced Soft Tissue Sarcoma · NA · recruiting
- NCT05146440 — Multicohort Trial of Different Schemes of PM14 in Monotherapy and in Combination with Radiotherapy in Soft Tissue Sarcom · Phase 1, PHASE2 · recruiting
Other European Organisation for Research and Treatment of Cancer - EORTC trials
Trials by the same sponsor.
- NCT07425808 — FLT3-ITD Targeted Therapy in Fit AML Patients · Phase 2, PHASE3 · not yet recruiting
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- NCT06809322 — Vorasidenib Maintenance for IDH Mutant Astrocytoma · Phase 3 · recruiting
- NCT06990061 — Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer: an Open-label, Single-arm, · NA · not yet recruiting
- NCT06783348 — Radiopharmaceutical Treatment of Advanced Kidney Cancer · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04780464 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by European Organisation for Research and Treatment of Cancer - EORTC
- Last refreshed: 22 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04780464.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing