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Alkylating agents

Ifosfamide for Osteosarcoma (EURAMOS-1 Trial)

Phase 3

Waitlist Available

Led By Neyssa Marina

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up adverse events are assessed for up to 10 years per participant.

Awards & highlights

EURAMOS-1 Trial Summary

This trial is studying different ways to treat osteosarcoma.

Eligible Conditions

Localized Osteosarcoma
Bone Sarcoma

EURAMOS-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ adverse events are assessed for up to 10 years per participant.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~adverse events are assessed for up to 10 years per participant.

This trial's timeline: 3 weeks for screening, Varies for treatment, and adverse events are assessed for up to 10 years per participant. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event-free Survival (EFS)

Secondary outcome measures

Percentage of Patients With Overall Survival

Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0

EURAMOS-1 Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Maintenance therapy group 2 arm IIExperimental Treatment8 Interventions

Patients receive doxorubicin IV continuously over 48 hours on days 1-2 in weeks 12, 20, 28, and 36 and cisplatin IV over 4 hours on days 1 and 2 in weeks 12 and 28. Patients also receive high-dose MTX IV over 4 hours on day 1 in weeks 15, 19, 23, 27, 31, 35, 39, and 40. Patients receive ifosfamide IV over 4 hours on days 1-5 in weeks 16, 24, and 32 and on days 1-3 in weeks 20 and 36 and etoposide IV over 1 hour on days 1-5 in weeks 16, 24, and 32.

Group II: Maintenance therapy group 1 arm IIExperimental Treatment7 Interventions

Patients receive doxorubicin, cisplatin, and high-dose MTX as in arm I. Patients than receive PEG-interferon alfa-2b subcutaneously once daily on day 1 in weeks 30-104.

Group III: Maintenance therapy group 1 arm IActive Control6 Interventions

Patients receive doxorubicin IV continuously over 48 hours on days 1-2 in weeks 12, 17, 22, and 26 and cisplatin IV over 4 hours on days 1 and 2 in weeks 12 and 17. Patients also receive high-dose MTX IV over 4 hours on day 1 in weeks 15, 16, 20, 21, 24, 25, 28, and 29.

Group IV: Maintenance therapy group 2 arm IActive Control6 Interventions

Patients receive doxorubicin, cisplatin, and high-dose MTX as in group 1 arm I.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Platinum

Not yet FDA approved

Ifosfamide

FDA approved

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850

Doxorubicin

FDA approved

Etoposide

FDA approved

Methotrexate

FDA approved

Interferon alfa-2b

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University College London HospitalsOTHER

188 Previous Clinical Trials

1,166,719 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,931,819 Total Patients Enrolled

103 Trials studying Osteosarcoma

15,284 Patients Enrolled for Osteosarcoma

University College, LondonOTHER

833 Previous Clinical Trials

38,909,055 Total Patients Enrolled

2 Trials studying Osteosarcoma

194 Patients Enrolled for Osteosarcoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please tell us the risks associated with Ifosfamide?

"Ifosfamide has been studied enough to warrant a Phase 3 trial, which is the last stage before FDA approval. We feel confident in its safety and rate it as a 3."

Answered by AI

What other similar research exists for this topic?

"Currently, there are 1,942 ongoing Ifosfamide studies taking place in 3,781 cities and 87 countries. The first ever trial was sponsored by Alfacell Corporation and took place back in 1997. That study saw 300 participants reach the drug's Phase 3 approval stage. In total, 3429 trials have been completed since that time."

Answered by AI

What is the standard protocol for Ifosfamide?

"kaposi's sarcoma aids related is frequently treated with Ifosfamide. However, this medication can also target other conditions such as merkel cell cancer, leukemia, and prostate cancer."

Answered by AI

Are there Ifosfamide studies currently being conducted elsewhere?

"The first clinical trial for ifosfamide was conducted at Spectrum Health Hospital - Butterworth Campus in 1997. Since then, there have been a total of 3429 completed studies with 1942 active trials currently underway. A notable number of these are being performed in Little Rock, Arkansas."

Answered by AI

Do elderly individuals qualify for this experiment?

"The minimum age requirement to enroll in this clinical trial is 5 years old while the maximum age limit is 40."

Answered by AI

Are there still positions available for volunteers in this research project?

"Unfortunately, this particular trial is not currently looking for new participants. It was first posted on November 14th, 2005 and last updated on June 6th, 2018. Although you may not be eligible for this study, there are 2056 other trials that might be a better match which are still recruiting."

Answered by AI

How many people are a part of this clinical trial in total?

"Unfortunately, this specific clinical trial is no longer recruiting patients. Although, it should be noted that there are 114 other trials involving osteosarcoma and 1942 studies utilising Ifosfamide currently looking for participants."

Answered by AI

Could I qualify to be a test subject for this clinical trial?

"This clinical trial is recruiting participants aged 5-40 who have osteosarcoma. Eligible patients must also meet the following criteria: Localized or metastatic disease, Short bone of upper limb, Long bone of lower limb, Short bone of lower limb, Vertebral column, Ribs, sternum, clavicle, or scapula, Tumor (primary, metastatic, or both) resectable OR is expected to become resectable after neoadjuvant induction chemotherapy, Long bone of upper limb Pelvic bones , sacrum , or coccyx."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Comparison of MAPIE Versus MAP in Patients with a Poor Response to Preoperative Chemotherapy for Newly Diagnosed High-grade Osteosarcoma (EURAMOS-1): An Open-label, International, Randomised Controlled Trial

Marina, Neyssa M, Sigbjørn Smeland, Stefan S Bielack, Mark Bernstein, Gordana Jovic, Mark D Krailo, Jane M Hook, et al.. 2016. “Comparison of MAPIE Versus MAP in Patients with a Poor Response to Preoperative Chemotherapy for Newly Diagnosed High-grade Osteosarcoma (EURAMOS-1): An Open-label, International, Randomised Controlled Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(16)30214-5.

Expert Opinion on Emerging DrugsJournal

An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?

Hattinger, Claudia Maria, Maria Pia Patrizio, Federica Magagnoli, Silvia Luppi, and Massimo Serra. 2019. “An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?”. Expert Opinion on Emerging Drugs. Informa UK Limited. doi:10.1080/14728214.2019.1654455.

Annals of OncologyJournal

EURAMOS-1, an International Randomised Study for Osteosarcoma: Results from Pre-randomisation Treatment

Whelan, J.S., S.S. Bielack, N. Marina, S. Smeland, G. Jovic, J.M. Hook, M. Krailo, et al.. 2015. “EURAMOS-1, an International Randomised Study for Osteosarcoma: Results from Pre-randomisation Treatment”. Annals of Oncology. Elsevier BV. doi:10.1093/annonc/mdu526.

BMJ OpenJournal