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

NCT03651375 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-01-22

No results posted yet for this study

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.

Conditions

  • Sarcoma
  • Fibrosarcoma
  • Leiomyosarcoma
  • Liposarcoma
  • Myosarcoma
  • Histiocytic Sarcoma
  • Synovial Sarcoma
  • Lymphangiosarcoma
  • Malignant Peripheral Nerve Sheath Tumors
  • Myxofibrosarcoma
  • Myxoid Liposarcoma
  • Undifferentiated Sarcoma
  • Pleomorphic Liposarcoma
  • Undifferentiated Pleomorphic Sarcoma
  • Dedifferentiated Liposarcoma
  • Pleomorphic Rhabdomyosarcoma
  • Malignant Triton Tumor

Interventions

DRUG

Sequential chemotherapy - 3 courses of AI

Three courses of doxorubicin and ifosfamide (AI, doxorubicin 75 mg/sqm and ifosfamide 10 g/sqm with prophylactic mesna), one before radiotherapy and two within the gap between radiotherapy and surgery.

RADIATION

Hypofractionated radiotherapy

Preoperative hypofractionated 5x5 Gy radiotherapy (5 consecutive days) prescribed on planned target volume (tumor volume + elective margins + setup/error margin) with a daily image guidance with cone beam-CT-based position verification.

Sponsors & Collaborators

  • Maria Sklodowska-Curie National Research Institute of Oncology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-11
Primary Completion
2019-12-31
Completion
2022-03-31

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03651375 on ClinicalTrials.gov