Study of drug combination therapy for patients with recurrent and primary refractory Ewing Sarcoma

4 1 1 1

What is this study about?

This clinical trial focuses on treating patients with Ewing Sarcoma that has either come back after treatment or did not respond to initial treatment. The study tests several chemotherapy medications including gemcitabine, docetaxel, irinotecan, temozolomide, topotecan, carboplatin, cyclophosphamide, ifosfamide, etoposide, and lenvatinib. The purpose is to determine which treatment combination works best in terms of effectiveness and side effects.

The treatment involves different combinations of these medications given either through an intravenous infusion into a vein or as oral capsules taken by mouth. Some medications are given daily while others are administered on specific days during treatment cycles that typically last several weeks. The total treatment duration may continue for up to 104 weeks depending on how well the treatment works.

Throughout the study, doctors will monitor the size of tumors using imaging scans to check if the treatment is working. They will also track any side effects and how long patients stay in the hospital. The study measures how long patients live without their disease getting worse and their overall survival time. Additionally, patients’ quality of life will be evaluated during the treatment period.

1 Initial assessment

Medical evaluation to confirm eligibility for the trial

Baseline imaging must be completed within 4 weeks before starting the treatment

For female patients who can become pregnant, a negative pregnancy test is required

2 Treatment assignment

Random assignment to one of the available treatment groups

Each group receives different combinations of anti-cancer medications

3 Treatment cycles

Treatment will be administered through oral medications (pills taken by mouth) or intravenous medications (given through a vein)

Imaging tests will be performed after 2 and 4 cycles of treatment to check response

Some treatment groups will have additional imaging after 6 cycles

A special imaging test called PET-CT will be done after 4 cycles

4 Regular monitoring

Regular checks of blood pressure

Monitoring of liver function

Assessment of kidney function

Heart function tests for specific treatment groups

Regular evaluation of side effects using standardized criteria

Quality of life assessments

5 Long-term follow-up

Continued monitoring of disease status

Recording of time without disease progression

Tracking of overall health status

Documentation of hospital stays

Patients who can become pregnant must use effective birth control during treatment and for 12 months after the last treatment

Who Can Join the Study?

  • Patient must have Ewing sarcoma or Ewing-like sarcoma confirmed by tissue examination (histology) either when first diagnosed or when disease progressed
  • Patient must be at least 2 years old
  • Patient must have evidence of disease progression during or after completing treatment
  • Patient must be medically fit to receive trial treatment
  • Patient must have adequate kidney function (with GFR of 60 ml/min/1.73m2 or higher)
  • Patient must agree to use effective birth control during treatment and for 12 months after last treatment
  • Female patients who can become pregnant must have a negative pregnancy test
  • Patient and/or parent/legal guardian must provide written informed consent
  • Imaging tests must be done within 4 weeks before starting the trial
  • For patients receiving specific treatment (IFOS/IFOS-L):
    • Liver function tests must be within certain limits
    • Heart function must show ejection fraction of 50% or higher
    • Blood pressure must be adequately controlled
    • Protein levels in urine must be within acceptable limits
  • Patient must be eligible for at least two treatment options in the study

Who Cannot Join the Study?

  • Patients who have not been diagnosed with Ewing Sarcoma (a type of bone or soft tissue cancer)
  • Patients younger than 6 years old or older than 65 years of age
  • Patients who have not experienced cancer recurrence (return of cancer) or have not shown resistance to initial treatment
  • Patients who cannot undergo systemic therapy (treatment that affects the entire body, such as chemotherapy)
  • Patients who are unable to complete imaging tests needed to monitor treatment response
  • Patients who are unable to provide informed consent or whose legal guardian cannot provide consent
  • Patients with severe medical conditions that would make participation unsafe
  • Patients currently participating in other clinical trials that could interfere with this study
  • Patients who are pregnant or breastfeeding
  • Patients with known allergies or sensitivities to the study medications
  • Patients who cannot comply with the study requirements or follow-up visits

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Institut Gustave Roussy Villejuif France
Oslo Universitetssykehus HF Oslo Norway
Hospital Universitario Y Politecnico La Fe Valencia Spain
Medical University Of Graz Graz Austria

Other Sites

Site Name City Country Status
Universitetssykehuset Nord-Norge HF Tromsø Norway
Hopital Des Enfants Toulouse France
Istituto Ortopedico Rizzoli Bologna Italy
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
St. Anna Kinderspital GmbH Vienna Austria
Hospital General Universitario Gregorio Maranon Madrid Spain
St. Olavs Hospital HF Trondheim Norway
Azienda Ospedaliera Santobono Pausilipon Naples Italy
Azienda Ospedaliera di Padova Padua Italy
Virgen del Rocío University Hospital Sevilla Spain
Stichting Radboud University Medical Center Nijmegen The Netherlands
Hospital Universitario De Cruces Barakaldo Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Universita’ Di Pisa Pisa Italy
Prinses Maxima Centrum voor Kinderoncologie B.V. Utrecht The Netherlands
Region Midtjylland Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Pirkanmaan hyvinvointialue Tampere Finland
Hospital Universitario De Canarias La Laguna Spain
Hopital Beaujon Clichy France
Servei De Salut De Les Illes Balears Palma Spain
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hospital Universitario Virgen De La Victoria Malaga Spain
Uniklinikum Salzburg Salzburg Austria
Cdiyixvaa Uydjbzonyaaqwv Sfmpzzung Woluwe-Saint-Lambert Belgium
Vqlaoxylajrtewwv hnfxkhfmbkrsbun Turku Finland
Cwltza Lzht Bhvsjh Lyon France
Irbpwv Imislxrk Fuawrwbtsogao Oqpgbtbisin Rome Italy
Iihttgds Clqixz Dkbvdodeuanfsxjzm L'hospitalet De Llobregat Spain
Uofurrxbyf Oe Ohqv Oulu Finland
Fjhngjzn nwzcsyxob Msseo a Hegrgqd Prague Czechia
Hfrvsp Hsmxlnhm Herlev Denmark
Atvgeouqof Pmzfosgd Havzrfar Df Mtoswligl Marseille France
Hsyeh Bpmxch Hh Bergen Norway
Bepeofsp Ugpuhyebna Hlgfdmzp Cnbqcb Besançon France
Hnvpmats Uqpqpvrnmr Ceywhbl Hulhlmst Helsinki Finland
Aaqoxcp Oirvbmsmrrx Ulfdqyynrkvbp Cqlwsattfvha Dnvna Sttgjq E Dlnbo Sfbgzxi Dx Taeapv Turin Italy
Hnhjxila Dr Lc Sxehe Czak I Ssrx Pmm Barcelona Spain
Fibovryvs Pbol Lx Izhjvluokbkka Bxtrtwmun Ddj Hxhjeapf Ukvlaaokjslvb Lk Pcb Madrid Spain
Jtddudtw Kytsaw Uyzncpjkpu Linz Austria
Hmgqoajo Vcuq dvlpqson Barcelona Spain
Hysedknx Ulmkbyclpeuqwe Swxhslyahx &nelidu Hvuzula dm Hpkechfldnn STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
06.07.2015
Belgium Belgium
Recruiting
06.07.2015
Czechia Czechia
Recruiting
06.07.2015
Denmark Denmark
Recruiting
06.07.2015
Finland Finland
Recruiting
06.07.2015
France France
Recruiting
06.07.2015
Italy Italy
Recruiting
06.07.2015
Norway Norway
Recruiting
06.07.2015
Spain Spain
Recruiting
06.07.2015
The Netherlands The Netherlands
Recruiting
06.07.2015

Trial locations

Based on the provided data, this appears to be a clinical trial comparing different chemotherapy regimens for Ewing Sarcoma. However, the specific medications are not listed in the provided source data. Without explicit information about which medications or therapies are being compared in the trial, I cannot provide detailed descriptions of individual treatments. The trial title and objective only indicate that it compares different chemotherapy regimens for treating recurrent and primary refractory Ewing Sarcoma, but does not specify which ones.

If you would like me to describe the medications involved in this trial, please provide additional data containing the specific treatments being studied.

Ewing Sarcoma – A rare type of cancer that forms in bone or soft tissue, typically affecting children and young adults. The disease usually develops in the bones, particularly the pelvis, chest wall, legs, or arms. It can spread to other parts of the body, especially to the lungs and other bones. Ewing sarcoma causes pain and swelling in the affected area, and may also lead to general symptoms such as fever and fatigue. The condition tends to be aggressive in its growth pattern and can recur after initial treatment.

Trial ID:
2024-516078-31-00
Protocol code:
RG_13-277
Trial Phase:
Therapeutic use (Phase IV)

Other Trials to Consider

  • Long-term safety study of GD2IL18CART treatment in patients with neuroblastoma, osteosarcoma, Ewing sarcoma, or advanced breast cancer

    Recruiting

    1 1 1
    Investigated drugs:
    Germany
  • Study of Regorafenib and Maintenance Chemotherapy for Newly Diagnosed Ewing Sarcoma Patients with Metastatic Disease

    Recruiting

    3 1 1 1
    Investigated diseases:
    Denmark France The Netherlands Norway Spain