RhabdomyosarcomaPhase 4NCT00339118
EpSSG (European Soft Tissue Sarcoma Study Group) Protocol for Non-Metastatic Rhabdomyosarcoma in Children
A Phase 4 study testing doxorubicin, cytoxan in people with Rhabdomyosarcoma, run by Sheba Medical Center.
Trial summary
The purpose of the study is achieve standardization treatment of low and intermediate risk rhabdomyosarcoma patients, with an attempt to improve treatment results in high and very high risk patients by the addition of doxorubicin as induction treatment and at the maintenance phase. Read more about this study
- Who is it for?
- Ages 6 months to 21 years
- Conditions the study is for
- Rhabdomyosarcoma
- What is being tested?
- doxorubicin, cytoxan
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- child
- non metastatic rhabdomyosarcoma
- adequate heart, kidney, liver function
Who cannot join
- age over 21 years, under 6 months
- metastatic disease
- heart, kidney, liver disease
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of the study is achieve standardization treatment of low and intermediate risk rhabdomyosarcoma patients, with an attempt to improve treatment results in high and very high risk patients by the addition of doxorubicin as induction treatment and at the maintenance phase.
- Conditions
- Rhabdomyosarcoma
- Being tested
- doxorubicin, cytoxan
- Medical subject headings
- Rhabdomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxorubicin, cytoxanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
event free survival
overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RhabdomyosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Iris Kventsel, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339118
- Sponsor's protocol ID
- SHEBA-06-4013-IK-CTIL
- Status last verified
- Jun 2006
- First submitted
- 19 Jun 2006
- Last updated
- 20 Jun 2006
- Results posted
- No
Publications
Bisogno G, Chisholm J, Hladun R, De Salvo GL, Guerin F, Casanova M, Mandeville H, Alaggio R, Coppadoro B, Orbach D, Ferrari A, van Rijn R, Defachelles AS, Ben-Arush M, Glosli H, Cesen M, Merks JHM, Minard-Colin V. Maintenance Chemotherapy in Patients With High-Risk Rhabdomyosarcoma: Long-Term Survival Analysis of the European Paediatric Soft Tissue Sarcoma Study Group RMS 2005 Trial. J Clin Oncol. 2025 Jun;43(16):1856-1862. doi: 10.1200/JCO-24-02850. Epub 2025 Mar 7.
PubMed 40053891Bisogno G, Minard-Colin V, Zanetti I, Ferrari A, Gallego S, Davila Fajardo R, Mandeville H, Kelsey A, Alaggio R, Orbach D, Terwisscha van Scheltinga S, Guillen Burrieza G, Ben-Arush M, Glosli H, Mudry P, Ferman S, Devalck C, Defachelles AS, Merks JHM, Jenney M. Nonmetastatic Rhabdomyosarcoma in Children and Adolescents: Overall Results of the European Pediatric Soft Tissue Sarcoma Study Group RMS2005 Study. J Clin Oncol. 2023 May 1;41(13):2342-2349. doi: 10.1200/JCO.22.02093. Epub 2023 Feb 27.
PubMed 36848614Bisogno G, De Salvo GL, Bergeron C, Gallego Melcon S, Merks JH, Kelsey A, Martelli H, Minard-Colin V, Orbach D, Glosli H, Chisholm J, Casanova M, Zanetti I, Devalck C, Ben-Arush M, Mudry P, Ferman S, Jenney M, Ferrari A; European paediatric Soft tissue sarcoma Study Group. Vinorelbine and continuous low-dose cyclophosphamide as maintenance chemotherapy in patients with high-risk rhabdomyosarcoma (RMS 2005): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2019 Nov;20(11):1566-1575. doi: 10.1016/S1470-2045(19)30617-5. Epub 2019 Sep 24.
PubMed 31562043
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EpSSG (European Soft Tissue Sarcoma Study Group) Protocol for Non-Metastatic Rhabdomyosarcoma in Children
- ClinicalTrials.gov ID
- NCT00339118
- Acronym / sponsor ID
- SHEBA-06-4013-IK-CTIL
- Conditions
- Rhabdomyosarcoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Sheba Medical CenterOther government
- First posted
- 20 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is achieve standardization treatment of low and intermediate risk rhabdomyosarcoma patients, with an attempt to improve treatment results in high and very high risk patients by the addition of doxorubicin as induction treatment and at the maintenance phase.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- child
- non metastatic rhabdomyosarcoma
- adequate heart, kidney, liver function
Key exclusion criteria (3 listed)
- age over 21 years, under 6 months
- metastatic disease
- heart, kidney, liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doxorubicin, cytoxan | Drug | – |
Primary outcome
event free survival
overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2006.
- Derived from this study: PubMed 40053891Bisogno G, Chisholm J, Hladun R, De Salvo GL, Guerin F, Casanova M, Mandeville H, Alaggio R, Coppadoro B, Orbach D, Ferrari A, van Rijn R, Defachelles AS, Ben-Arush M, Glosli H, Cesen M, Merks JHM, Minard-Colin V. Maintenance Chemotherapy in Patients With High-Risk Rhabdomyosarcoma: Long-Term Survival Analysis of the European Paediatric Soft Tissue Sarcoma Study Group RMS 2005 Trial. J Clin Oncol. 2025 Jun;43(16):1856-1862. doi: 10.1200/JCO-24-02850. Epub 2025 Mar 7.
- Derived from this study: PubMed 36848614Bisogno G, Minard-Colin V, Zanetti I, Ferrari A, Gallego S, Davila Fajardo R, Mandeville H, Kelsey A, Alaggio R, Orbach D, Terwisscha van Scheltinga S, Guillen Burrieza G, Ben-Arush M, Glosli H, Mudry P, Ferman S, Devalck C, Defachelles AS, Merks JHM, Jenney M. Nonmetastatic Rhabdomyosarcoma in Children and Adolescents: Overall Results of the European Pediatric Soft Tissue Sarcoma Study Group RMS2005 Study. J Clin Oncol. 2023 May 1;41(13):2342-2349. doi: 10.1200/JCO.22.02093. Epub 2023 Feb 27.
- Derived from this study: PubMed 31562043Bisogno G, De Salvo GL, Bergeron C, Gallego Melcon S, Merks JH, Kelsey A, Martelli H, Minard-Colin V, Orbach D, Glosli H, Chisholm J, Casanova M, Zanetti I, Devalck C, Ben-Arush M, Mudry P, Ferman S, Jenney M, Ferrari A; European paediatric Soft tissue sarcoma Study Group. Vinorelbine and continuous low-dose cyclophosphamide as maintenance chemotherapy in patients with high-risk rhabdomyosarcoma (RMS 2005): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2019 Nov;20(11):1566-1575. doi: 10.1016/S1470-2045(19)30617-5. Epub 2019 Sep 24.
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Rhabdomyosarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iris Kventsel, MD principal investigator
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing doxorubicin, cytoxan in people with Rhabdomyosarcoma, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iris Kventsel, MD (97235303037, iris.kventsel@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
event free survival. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339118, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2006.