Clinical trial · Interventional
Hypofractionated Radiotherapy With Sequential Chemotherapy in Marginally Resectable Soft Tissue Sarcomas of Extremities or Trunk Wall
Hypofractionated 5x5 Gy Radiotherapy With Sequential Doxorubicin and Ifosfamide-based Chemotherapy in Marginally Resectable Soft Tissue Sarcomas of Extremities or Trunk Wall
NCT03651375CI-TRIAL-00049554UN-RESARCunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
After a screening, which consists of biopsy, physical examination, initial diffusion-weighted magnetic resonance imaging (DWI-MRI), body computed tomography (CT) scan, blood tests and case analysis on Multidisciplinary Team (MDT) meeting, a patient will receive the first course of chemotherapy - doxorubicin 75 mg/sqm and ifosfamide 10 g/sqm (AI regimen) with prophylactic mesna. Then a patient will be irradiated 5x5 Gy and after radiotherapy he or she will receive two courses of AI within 4-6 weeks, depending on the tolerance. Then the response analysis in DWI-MRI and toxicity assessment and will be performed. On the second MDT meeting, a final decision about resectability of the tumor will be made. In case of resectability, a patient will be referred to surgery.
Conditions
Conditions (17)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dedifferentiated Liposarcoma | Dedifferentiated Liposarcoma | ONTOLOGY_EXACT | 0.98 |
| Fibrosarcoma | Fibrosarcoma | ONTOLOGY_EXACT | 0.90 |
| Histiocytic Sarcoma | Histiocytic Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Leiomyosarcoma | Leiomyosarcoma | ONTOLOGY_EXACT | 0.90 |
| Liposarcoma | Liposarcoma | ONTOLOGY_EXACT | 0.90 |
| Lymphangiosarcoma | Lymphangiosarcoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Peripheral Nerve Sheath Tumors | Malignant Peripheral Nerve Sheath Tumor | ONTOLOGY_EXACT | 0.90 |
| Malignant Triton Tumor |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
| Sequential chemotherapy - 3 courses of AI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sequential chemoradiotherapy
- description
- 1xAI (doxorubicin 75 mg/sqm and ifosfamide 10 g/sqm) + 5x5 Gy radiotherapy + 2xAI + surgery
- interventionNames
- Drug: Sequential chemotherapy - 3 courses of AI
- Radiation: Hypofractionated radiotherapy
Primary outcomes (1)
- measure
- The ratio of en limb-sparing/conservative R0 resections.
- timeFrame
- 24 months
Secondary outcomes (5)
- measure
- Radiological response in diffusion-weighted MRI
- timeFrame
- 24 months
- description
- Radiological assessment of tumor change, especially diffusion parameters in DWI-MRI 6 weeks after the end of irradiation, according to the EORTC criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Able to provide informed consent * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 * Age ≥18 years old * Histologic diagnosis of soft tissue sarcoma * Primary or recurrent tumor localized on extremities or trunk * Grade 2 or grade 3 tumor * Marginally resectable tumor as assessed by a multidisciplinary team * Adequate renal function (serum creatinine ≤ 1.5 ULN) * Adequate liver function (total bilirubin, AST, ALT 3x \< ULN) Exclusion Criteria: * Radiation-induced sarcoma * Second active malignancy, not including localized basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast; patients with a history of other malignancies are eligible if they have been continuously disease-free for \> 10 years prior to the time of registration. * History of radiation to the affected volume * Histologic diagnosis of rhabdomyosarcoma (except pleomorphic subtype), angiosarcoma, epithelioid sarcoma, clear cell sarcoma, extraskeletal chondrosarcoma, alveolar soft part sarcoma, osteogenic sarcoma, Ewing's sarcoma/PPNET, aggressive fibromatosis, dermatofibrosarcoma protuberans * Contraindications to radiotherapy, chemotherapy or surgery * Metastatic disease except primary resectable isolated lung metastases
References
Publications (15)
- BACKGROUNDBarker HE, Paget JT, Khan AA, Harrington KJ. The tumour microenvironment after radiotherapy: mechanisms of resistance and recurrence. Nat Rev Cancer. 2015 Jul;15(7):409-25. doi: 10.1038/nrc3958. PMID 26105538
- BACKGROUNDDumars C, Ngyuen JM, Gaultier A, Lanel R, Corradini N, Gouin F, Heymann D, Heymann MF. Dysregulation of macrophage polarization is associated with the metastatic process in osteosarcoma. Oncotarget. 2016 Nov 29;7(48):78343-78354. doi: 10.18632/oncotarget.13055. PMID 27823976
- BACKGROUNDEllingsen C, Andersen LM, Galappathi K, Rofstad EK. Hypoxia biomarkers in squamous cell carcinoma of the uterine cervix. BMC Cancer. 2015 Oct 26;15:805. doi: 10.1186/s12885-015-1828-2. PMID 26502718
- BACKGROUNDFujiwara T, Fukushi J, Yamamoto S, Matsumoto Y, Setsu N, Oda Y, Yamada H, Okada S, Watari K, Ono M, Kuwano M, Kamura S, Iida K, Okada Y, Koga M, Iwamoto Y. Macrophage infiltration predicts a poor prognosis for human ewing sarcoma. Am J Pathol. 2011 Sep;179(3):1157-70. doi: 10.1016/j.ajpath.2011.05.034. Epub 2011 Jul 21. PMID 21771572
- BACKGROUNDGanjoo KN, Witten D, Patel M, Espinosa I, La T, Tibshirani R, van de Rijn M, Jacobs C, West RB. The prognostic value of tumor-associated macrophages in leiomyosarcoma: a single institution study. Am J Clin Oncol. 2011 Feb;34(1):82-6. doi: 10.1097/coc.0b013e3181d26d5e. PMID 23781555
- BACKGROUNDGronchi A, Ferrari S, Quagliuolo, Broto M, J, Lopez-Pousa A, Grignani G, et al. Full-dose neoadjuvant anthracycline + ifosfamide chemotherapy is associated with a relapse free survival (RFS) and overall survival (OS) benefit in localized high-risk adult soft tissue sarcomas (STS) of the extremities and trunk wall: Interim analysis of a prospective randomized trial. Annals of Oncology, Volume 27, Issue suppl_6, 1 October 2016 https://academic.oup.com/annonc/article/27/suppl_6/LBA6_PR/2800561
- BACKGROUNDJiang S, Yang Y, Fang M, Li X, Yuan X, Yuan J. Co-evolution of tumor-associated macrophages and tumor neo-vessels during cervical cancer invasion. Oncol Lett. 2016 Oct;12(4):2625-2631. doi: 10.3892/ol.2016.5014. Epub 2016 Aug 16.