Sarcoma Clinical Trial
— UN-RESARCOfficial title:
Hypofractionated 5x5 Gy Radiotherapy With Sequential Doxorubicin and Ifosfamide-based Chemotherapy in Marginally Resectable Soft Tissue Sarcomas of Extremities or Trunk Wall
Verified date | December 2020 |
Source | Maria Sklodowska-Curie Institute - Oncology Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 46 |
Est. completion date | March 2022 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Maria Sklodowska-Curie Institute - Oncology Center | Warsaw | Mazovian |
Lead Sponsor | Collaborator |
---|---|
Maria Sklodowska-Curie Institute - Oncology Center |
Poland,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Assessment of biomarkers in biopsy and post-operative material | HIF-1 (hypoxia-inducible factor 1) - marker of hypoxia, predicting tumor response on radiotherapy; CD105/CD31/VEGF-A - tumor microvessel density; CD14, CD163, CD68KP i CD68 PG-M1 - tumor associated macrophages. | 24 months | |
Primary | The ratio of en limb-sparing/conservative R0 resections. | 24 months | ||
Secondary | Radiological response in diffusion-weighted MRI | Radiological assessment of tumor change, especially diffusion parameters in DWI-MRI 6 weeks after the end of irradiation, according to the EORTC criteria. | 24 months | |
Secondary | Pathological response in resected tumors according to EORTC Soft Tissue and Bone Sarcoma Group criteria | 24 months | ||
Secondary | Toxicity of planned schedule of therapy according to CTCAE v.4.0. | The study will be stopped prematurely if the rate of non-hematological toxicity grade 3 >30% | 24 months after treatment completion | |
Secondary | 2-years overall survival | 24 months after treatment completion | ||
Secondary | 2-years local control rate | 24 months after treatment completion |
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