Clinical trial · Interventional
Neoadjuvant and Adjuvant Chemotherapy in High-risk Soft Tissue Sarcoma
A Phase II Study Evaluating Neo-/Adjuvant EIA Chemotherapy, Surgical Resection and Radiotherapy in High-risk Soft Tissue Sarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Neo- and adjuvant chemotherapy is used in high-risk soft tissue sarcoma to improve systemic control. Patients in this trial are treated with 4 cycles of chemotherapy (EIA, etoposide, ifosfamide, adriamycin) preoperatively, followed by local surgery and radiotherapy. An additional 4 cycles of adjuvant chemotherapy is administered. Treatment response is assessed by MRI and CT scans and FDG-PET in a subgroup of patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EIA chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- All patients receive 4 cycles of EIA chemotherapy pre- and postoperatively. There is no further observation arm. The study is non-randomized.
- interventionNames
- Drug: EIA chemotherapy
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 2 years after study completion
- description
- Disease-free survival will be calculated from the time of definite surgery to radiologically proven local or distant failure or patient´s death due to sarcoma related cause.
Secondary outcomes (8)
- measure
- Overall Survival
- timeFrame
- 2 years after study completion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Soft tissue sarcoma histology * Tumor size \>= 5 cm * Deep/extracompartimental localization * Grade 2/3 (FNCLCC) * Patients with inadequate previous therapy * Age 18-65 years * normal bone marrow function * normal liver function * normal renal function * Karnofsky index \>=80% Exclusion Criteria: * Chordoma * Chondrosarcoma * Kaposi´ sarcoma * Neuroblastoma * Mesothelioma * Osteosarcoma/Ewings´sarcoma
References
Publications (2)
- DERIVEDRoeder F, Lehner B, Schmitt T, Kasper B, Egerer G, Sedlaczek O, Grullich C, Mechtersheimer G, Wuchter P, Hensley FW, Huber PE, Debus J, Bischof M. Excellent local control with IOERT and postoperative EBRT in high grade extremity sarcoma: results from a subgroup analysis of a prospective trial. BMC Cancer. 2014 May 20;14:350. doi: 10.1186/1471-2407-14-350. PMID 24885755
- DERIVEDSchmitt T, Lehner B, Kasper B, Bischof M, Roeder F, Dietrich S, Dimitrakopoulou-Strauss A, Strauss LG, Mechtersheimer G, Wuchter P, Ho AD, Egerer G. A phase II study evaluating neo-/adjuvant EIA chemotherapy, surgical resection and radiotherapy in high-risk soft tissue sarcoma. BMC Cancer. 2011 Dec 7;11:510. doi: 10.1186/1471-2407-11-510. PMID 22152120