Recurrent Childhood Soft Tissue SarcomaTrIPReSarcNCT02509234
Trabectedin and Irinotecan for Refractory Pediatric Sarcomas
An observational study of Recurrent Childhood Soft Tissue Sarcoma and Recurrent Ewing Sarcoma, run by Technical University of Munich.
Trial summary
The purpose of the study is to evaluate patients with refractory childhood sarcomas, who have been treated with a combination therapy of trabectedin and irinotecan (within compassionate use), to determine, if this is a promising treatment option with acceptable toxicity and if the results warrant a prospective study. Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma, Recurrent Rhabdomyosarcoma
- What is being tested?
- Combined chemotherapy with trabectedin followed by irinotecan
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Jul 2017
- Phase
- Observational
- 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 10 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents and young adults (age10 - 40 yoa) with refractory sarcoma
Who may be able to join
- Adolescents and young adults (age10 - 40 yoa) with refractory sarcoma, for which there are presently no further treatment options in EURO-Ewing/ EURAMOS/CWS (i.e. ≥ second relapse in ES, resistance to surgery in osteosarcoma, relapsed rhabdomyosarcoma) and have been treated with a combined chemotherapy of trabectedin and irinotecan (described in intervention)
- existing matched control in existing study databases
- have started of treatment within three months of last progress
Who cannot join
- Patients newly diagnosed or in first relapse.
About this study
Official title: Trabectedin and Irinotecan in Pediatric Refractory Sarcomas
The purpose of the study is to evaluate patients with refractory childhood sarcomas, who have been treated with a combination therapy of trabectedin and irinotecan (within compassionate use), to determine, if this is a promising treatment option with acceptable toxicity and if the results warrant a prospective study.
- Conditions
- Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma, Recurrent Rhabdomyosarcoma
- Being tested
- Combined chemotherapy with trabectedin followed by irinotecan
- Keywords
- pediatric sarcomas, Ewing sarcoma, rhabdomyosarcoma, soft tissue sarcoma
- Medical subject headings
- Sarcoma, Ewing, Rhabdomyosarcoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined chemotherapy with trabectedin followed by irinotecanDrug
Day 1:
Trabectedin 1,1 - 1,5 mg/m²/day i.v.
Day 3-5 and 10-12:
Irinotecan 30- 90 mg/m²/day p.o. or i.v.
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity during therapy
WHO toxicity grading
Measured: As long as patient is undergoing therapy/ 6 months
Secondary outcomes (3)
Quality of life
Assessment of quality of life at the day before starting the next cycle and at months 3, 6, 9 and 12 after start of treatment, using adapted Karnofsky Score.
Measured: 12 months
Assessment of therapeutic effect
Read out after every two cycles (functional imaging, PET-MRT/PET-CT), evaluation according to RECIST.
Measured: 12 months
Assessment of time to treatment failure
Read out after every two cycles (functional imaging, PET-MRT/PET-CT), evaluation according to RECIST.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startFeb 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Childhood Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Burdach, Prof., Study chair, Kinderklinik München Schwabing - Klinik und Poliklinik für Kinder- und Jugendmedizin, Klinikum Schwabing, Städtisches Klinikum München GmbH und Klinikum Rechts der Isar (AöR) der Technischen Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509234
- Sponsor's protocol ID
- TrI.PReSarc V150429
- Acronym
- TrIPReSarc
- Status last verified
- Jul 2015
- First submitted
- 1 Jul 2015
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trabectedin and Irinotecan in Pediatric Refractory Sarcomas
- ClinicalTrials.gov ID
- NCT02509234
- Acronym / sponsor ID
- TrIPReSarc / TrI.PReSarc V150429
- Conditions
- Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma, Recurrent Rhabdomyosarcoma
- Keywords
- pediatric sarcomas, Ewing sarcoma, rhabdomyosarcoma, soft tissue sarcoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 27 Jul 2015 (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 to evaluate patients with refractory childhood sarcomas, who have been treated with a combination therapy of trabectedin and irinotecan (within compassionate use), to determine, if this is a promising treatment option with acceptable toxicity and if the results warrant a prospective study.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents and young adults (age10 - 40 yoa) with refractory sarcoma
Key inclusion criteria (3 listed)
- Adolescents and young adults (age10 - 40 yoa) with refractory sarcoma, for which there are presently no further treatment options in EURO-Ewing/ EURAMOS/CWS (i.e. ≥ second relapse in ES, resistance to surgery in osteosarcoma, relapsed rhabdomyosarcoma) and have been treated with a combined chemotherapy of trabectedin and irinotecan (described in intervention)
- existing matched control in existing study databases
- have started of treatment within three months of last progress
Key exclusion criteria (1 listed)
- Patients newly diagnosed or in first relapse.
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 |
|---|---|---|
| Combined chemotherapy with trabectedin followed by irinotecanDay 1: Trabectedin 1,1 - 1,5 mg/m²/day i.v. Day 3-5 and 10-12: Irinotecan 30- 90 mg/m²/day p.o. or i.v. | Drug | – |
Primary outcome
Toxicity during therapy
Time frame: As long as patient is undergoing therapy/ 6 months
WHO toxicity grading
3 secondary outcomes
Quality of life
Time frame: 12 months
Assessment of therapeutic effect
Time frame: 12 months
Assessment of time to treatment failure
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
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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.
Stefan Burdach, Prof. study chair
Kinderklinik München Schwabing - Klinik und Poliklinik für Kinder- und Jugendmedizin, Klinikum Schwabing, Städtisches Klinikum München GmbH und Klinikum Rechts der Isar (AöR) der Technischen Universität München
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Childhood Soft Tissue Sarcoma and Recurrent Ewing Sarcoma, run by Technical University of Munich.
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 1 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 27 Jul 2015. 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.
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?
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?
Toxicity during therapy (time frame: As long as patient is undergoing therapy/ 6 months). 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 27 Jul 2015.