RhabdomyosarcomaPhase 3NCT00162695
Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood
A Phase 3 study testing Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide in people with Rhabdomyosarcoma and Malignant Soft Tissue, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
Objective of the study objectives was to explore survival advantage for an intensified chemotherapy strategy in a randomised trial. IVA (ifosfamide, vincristine, actinomycin D) or a 6 drug combination (IVA + carboplatin, epirubicin, etoposide) both delivered over 27 weeks. Read more about this study
- Who is it for?
- Ages 6 months to 21 years
- Conditions the study is for
- Rhabdomyosarcoma, Malignant Soft Tissue
- What is being tested?
- Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Jul 1995to not given
- Phase
- Phase 3
- 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
- age > 6 months and < 18 years
- no distant metastases
- diagnosis within previous 8 weeks without prior treatment except surgery
- pathology available for central review
- written consent according to institutional requirement
Who cannot join
- stage III (node positive)
- stage I or II non alveolar orbital tumours
- patients with parameningeal disease aged < 3 years
Trial locations and contacts
1 site in 1 country.
About this study
Objective of the study objectives was to explore survival advantage for an intensified chemotherapy strategy in a randomised trial.
IVA (ifosfamide, vincristine, actinomycin D) or a 6 drug combination (IVA + carboplatin, epirubicin, etoposide) both delivered over 27 weeks. Cumulative dose / m2 = ifosfamide 54g (both arms), epirubicin 450 mg, etoposide 1350 mg (6 drug). Delivery of radiotherapy was determined according to site and / or response to chemotherapy ± surgery.
The study was powered to detect 10% difference in 3 year OS.
- Conditions
- Rhabdomyosarcoma, Malignant Soft Tissue
- Being tested
- Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide
- Medical subject headings
- Rhabdomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore survival advantage for an intensified chemotherapy strategy in a randomised trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startJul 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhabdomyosarcomaStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Investigators
- Odile OBERLIN, Dr, Principal investigator, Gustave Roussy, Cancer Campus, Grand ParisMichael STEVENS, Dr, Principal investigator, Hospital of Bristols, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162695
- Sponsor's protocol ID
- RMS95
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 13 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood
- ClinicalTrials.gov ID
- NCT00162695
- Acronym / sponsor ID
- RMS95
- Conditions
- Rhabdomyosarcoma, Malignant Soft Tissue
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 400 participants
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Jul 1995
- First posted
- 13 Sep 2005 (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.
Objective of the study objectives was to explore survival advantage for an intensified chemotherapy strategy in a randomised trial.
IVA (ifosfamide, vincristine, actinomycin D) or a 6 drug combination (IVA + carboplatin, epirubicin, etoposide) both delivered over 27 weeks. Cumulative dose / m2 = ifosfamide 54g (both arms), epirubicin 450 mg, etoposide 1350 mg (6 drug). Delivery of radiotherapy was determined according to site and / or response to chemotherapy ± surgery.
The study was powered to detect 10% difference in 3 year OS.
Study design
- Primary purpose
- Treatment
- 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 (5 listed)
- age > 6 months and < 18 years
- no distant metastases
- diagnosis within previous 8 weeks without prior treatment except surgery
- pathology available for central review
- written consent according to institutional requirement
Key exclusion criteria (3 listed)
- stage III (node positive)
- stage I or II non alveolar orbital tumours
- patients with parameningeal disease aged < 3 years
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 |
|---|---|---|
| Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide | Drug | – |
Primary outcome
To explore survival advantage for an intensified chemotherapy strategy in a randomised trial
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2005.
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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.
Odile OBERLIN, Dr principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
Michael STEVENS, Dr principal investigator
Hospital of Bristols, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide in people with Rhabdomyosarcoma and Malignant Soft Tissue, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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 5 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: stopped early, as of the sponsor's last update on 13 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore survival advantage for an intensified chemotherapy strategy in a randomised trial. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2005.