Neoplasms

All Conditions

Nervous System Diseases

Blood and Lymph Conditions

Skin and Connective Tissue Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Sarcoma

Liposarcoma

Histiocytoma, Malignant Fibrous

Fibrosarcoma

Leiomyosarcoma

Rhabdomyosarcoma

Sarcoma, Synovial

Nerve Sheath Neoplasms

Neurofibrosarcoma

Liposarcoma, Myxoid

Histiocytic Sarcoma

Lymphangiosarcoma

Myosarcoma

Histiocytoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Adipose Tissue

Neoplasms, Connective Tissue

Neoplasms, Nerve Tissue

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neoplasms, Fibrous Tissue

Neurofibromatoses

Neurofibroma

Histiocytic Disorders, Malignant

Histiocytosis

Lymphatic Diseases

Soft Tissue Sarcoma

Undifferentiated Pleomorphic Sarcoma

Synovial Sarcoma

Malignant Peripheral Nerve Sheath Tumor

Embryonal Sarcoma

Myxoid Liposarcoma

Neurofibromatosis

Antineoplastic Agents

All Drugs and Chemicals

Doxorubicin

Liposomal doxorubicin

Ifosfamide

Isophosphamide mustard

Mesna

1xAI (doxorubicin 75 mg/sqm and ifosfamide 10 g/sqm) + 5x5 Gy radiotherapy + 2xAI + surgery

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.

Sequential chemotherapy - 3 courses of AI

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.

Hypofractionated radiotherapy

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.

There is lack of standard treatment of marginally resectable sarcomas. Results of commonly used approaches are unsatisfactory. The addition of neoadjuvant/induction chemotherapy before the irradiation and in the prolonged gap between the end of hypofractionated 5x5 Gy radiotherapy and surgery may allow to obtain the R0 resection rate, high pathological response rate and/or a higher rate of limb-sparing/conservative surgery as well as to increase patients' survival.

Hypofractionation represents a variation of radiotherapy fractionation in which the total dose is divided into fewer fractions with an increased fraction dose. Such treatment may lead to additional biological effects when compared to conventionally fractionated radiotherapy (eg. vascular damage, increased immunogenicity, and antigenicity). The main advantages of hypofractionation are those related to the decreased overall treatment time what is more convenient for both patients and physicians, increased compliance and makes the treatment more cost-effective. Intriguing, such an approach may provide an additional benefit when treating non-radiosensitive tumors with a low alpha/beta ratio (eg. sarcomas).

The basis of the study was a trial conducted by Kosela et al. in our center, which showed that preoperative short 5x5 Gy radiotherapy with immediate surgery is an effective and well-tolerated treatment of resectable sarcomas of extremities or trunk wall.

The rationale of chemotherapy comes from the interim analysis of a multicenter, international EORTC study comparing neoadjuvant systemic approaches in high-risk sarcomas. It was proven that AI regimen, which consists of ifosfamide and anthracyclines allowed to obtain 20% benefit in relapse-free survival and overall survival as compared to pathologically-tailored chemotherapy.

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

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.

Radiological assessment of tumor change, especially diffusion parameters in DWI-MRI 6 weeks after the end of irradiation, according to the EORTC criteria.

The study will be stopped prematurely if the rate of non-hematological toxicity grade 3 \>30%

Maria Sklodowska-Curie National Research Institute of Oncology

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Digestive System Diseases

Gland and Hormone Related Diseases

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Prostatic Neoplasms

Breast Neoplasms

Syndrome

Esophageal Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Thyroid Neoplasms

Thyroid Diseases

Carcinoma, Renal Cell

Facies

Head and Neck Neoplasms

Solitary Pulmonary Nodule

Mesothelioma

Mesothelioma, Malignant

Osteosarcoma

Mouth Neoplasms

Carcinosarcoma

Mixed Tumor, Mullerian

Chondrosarcoma

Carcinoma, Bronchogenic

Hemangiosarcoma

Kidney Neoplasms

Carcinoma, Small Cell

Phyllodes Tumor

Hemangioma

Adenoma, Pleomorphic

Parathyroid Neoplasms

Otorhinolaryngologic Neoplasms

Pancoast Syndrome

Adenosarcoma

Mixed Tumor, Mesodermal

Tracheal Neoplasms

Facial Neoplasms

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Renal Cell Carcinoma

Malignant Mesothelioma

Oral Cancer

Malignant Mixed Mullerian Tumor

Androgens

Fluorouracil

Belinostat

Parathyroid Hormone

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Histone Deacetylase Inhibitors

Enzyme Inhibitors

300, 600, or 1000 mg/m2 belinostat IV for 5 days every 21 days starting with cycle 1

belinostat

250, 500, 750, or 1000 mg/m2/d of 5-FU starting with cycle 2 onwards in combination with belinostat. Starting on day 2, 5-FU is administered as a continuous 96 hour infusion.

5-Fluorouracil (5-FU)

Topotarget A/S

This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).

Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors

A Phase I Safety, Pharmacodynamic, Anti-Tumor Activity, and Pharmacokinetic Study of PXD101 Alone and in Combination With 5-Fluorouracil in Patients With Advanced Solid Tumors

Valerio Therapeutics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hypofractionated Radiotherapy With Sequential Chemotherapy in Marginally Resectable Soft Tissue Sarcomas of Extremities or Trunk Wall	NCT03651375	Sarcoma Fibrosarcoma Leiomyosarcoma Liposarcoma Myosarcoma Histiocytic Sar... Synovial Sarcom... Lymphangiosarco... Malignant Perip... Myxofibrosarcom... Myxoid Liposarc... Undifferentiate... Pleomorphic Lip... Undifferentiate... Dedifferentiate... Pleomorphic Rha... Malignant Trito...	Sequential chem... Hypofractionate...	18 Years - 100 Years	Maria Sklodowska-Curie National Research Institute of Oncology
Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors	NCT00413322	Tumor	belinostat 5-Fluorouracil ...	18 Years -	Valerio Therapeutics
Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors	NCT00413322	Tumor	belinostat 5-Fluorouracil ...	18 Years -	Valerio Therapeutics
Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors	NCT00413322	Tumor	belinostat 5-Fluorouracil ...	18 Years -	Valerio Therapeutics
Hypofractionated Radiotherapy With Sequential Chemotherapy in Marginally Resectable Soft Tissue Sarcomas of Extremities or Trunk Wall	NCT03651375	Sarcoma Fibrosarcoma Leiomyosarcoma Liposarcoma Myosarcoma Histiocytic Sar... Synovial Sarcom... Lymphangiosarco... Malignant Perip... Myxofibrosarcom... Myxoid Liposarc... Undifferentiate... Pleomorphic Lip... Undifferentiate... Dedifferentiate... Pleomorphic Rha... Malignant Trito...	Sequential chem... Hypofractionate...	18 Years - 100 Years	Maria Sklodowska-Curie National Research Institute of Oncology

Spots Global Cancer Trial Database for lymphangiosarcoma