Hypofractionated Radiotherapy With Sequential Chemotherapy in Marginally Resectable Soft Tissue Sarcomas of Extremities or Trunk Wall

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maria Sklodowska-Curie Institute - Oncology Center
• Treatments: Antineoplastic Agents; Doxorubicin; Ifosfamide; Isophosphamide mustard; Liposomal doxorubicin

Criteria

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