Unresectable Localized Soft Tissue SarcomaPhase 2NCT02784015
Response Based Treatment for Children With Unresectable Localized Soft Tissue Sarcoma
A Phase 2 study testing Cisplatin, Etoposide and Doxorubicin in people with Unresectable Localized Soft Tissue Sarcoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To evaluate the treatment outcome of unresectable soft tissue sarcoma using response based treatment Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Unresectable Localized Soft Tissue Sarcoma
- What is being tested?
- Cisplatin, Etoposide and Doxorubicin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2016to May 2023
- Phase
- Phase 2
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with unresectable localized high grade soft tissue sarcoma
Who cannot join
- Patients with organ dysfunction (ejection fraction, liver function test, creatinine > CTCAE grade 2)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Ki Woong Sung, 82-2-3410-3529, kwsped@skku.edu
Ki Woong Sung
About this study
Official title: Response-based Treatment for Children With Unresectable Localized Soft Tissue Sarcomas
To evaluate the treatment outcome of unresectable soft tissue sarcoma using response based treatment
Read the detailed description
Response after initial chemotherapy is one of the important prognostic factor in many cancers. In this study, treatment will be tailored according to the treatment responses which are assessed by tumor volume reduction, necrosis rate or residual fludeoxyglucose (FDG) uptake in positron emission tomography (PET) scan.
- Being tested
- Cisplatin, Etoposide, Doxorubicin, Cyclophosphamide, Ifosfamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
EtoposideDrug
DoxorubicinDrug
CyclophosphamideDrug
IfosfamideDrug
CarboplatinDrug
RadiotherapyRadiation
ThiotepaDrug
MelphalanDrug
| Study group | Role | What they receive |
|---|---|---|
| Unresectable localized soft tissue sarcoma | Experimental | 1. Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen.
2. Surgery, if possible
3. Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan)
4. Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation, if there are still residual tumors after 9 cycle of chemotherapy, surgery, and radiotherapy.
* 1st HDCT: carboplatin, thiotepa, etoposide
* 2nd HDCT: cyclophosphamide, melphalan Receives: Drug: Cisplatin; Drug: Etoposide; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Ifosfamide; Drug: Carboplatin; Radiation: Radiotherapy; Drug: Thiotepa; Drug: Melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of event free survival
Measured: Up to 3 years
Secondary outcomes (1)
Rate of adverse events
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2020 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Localized Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784015
- Sponsor's protocol ID
- 2015-07-115
- Status last verified
- Sep 2018
- First submitted
- 24 May 2016
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response-based Treatment for Children With Unresectable Localized Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT02784015
- Acronym / sponsor ID
- 2015-07-115
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 26 May 2016 (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.
To evaluate the treatment outcome of unresectable soft tissue sarcoma using response based treatment
Detailed description
Response after initial chemotherapy is one of the important prognostic factor in many cancers. In this study, treatment will be tailored according to the treatment responses which are assessed by tumor volume reduction, necrosis rate or residual fludeoxyglucose (FDG) uptake in positron emission tomography (PET) scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unresectable localized soft tissue sarcoma | Experimental | Drug: Cisplatin, Drug: Etoposide, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: Ifosfamide, Drug: Carboplatin, Radiation: Radiotherapy, Drug: Thiotepa, Drug: Melphalan1. Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen. 2. Surgery, if possible 3. Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan) 4. Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation, if there are still residual tumors after 9 cycle of chemotherapy, surgery, and radiotherapy. * 1st HDCT: carboplatin, thiotepa, etoposide * 2nd HDCT: cyclophosphamide, melphalan |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with unresectable localized high grade soft tissue sarcoma
Key exclusion criteria (1 listed)
- Patients with organ dysfunction (ejection fraction, liver function test, creatinine > CTCAE grade 2)
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 |
|---|---|---|
| Cisplatin | Drug | Unresectable localized soft tissue sarcoma |
| Etoposide | Drug | Unresectable localized soft tissue sarcoma |
| Doxorubicin | Drug | Unresectable localized soft tissue sarcoma |
| Cyclophosphamide | Drug | Unresectable localized soft tissue sarcoma |
| Ifosfamide | Drug | Unresectable localized soft tissue sarcoma |
| Carboplatin | Drug | Unresectable localized soft tissue sarcoma |
| Radiotherapy | Radiation | Unresectable localized soft tissue sarcoma |
| Thiotepa | Drug | Unresectable localized soft tissue sarcoma |
| Melphalan | Drug | Unresectable localized soft tissue sarcoma |
Primary outcome
Rate of event free survival
Time frame: Up to 3 years
1 secondary outcome
Rate of adverse events
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin, Etoposide and Doxorubicin in people with Unresectable Localized Soft Tissue Sarcoma, run by Samsung Medical Center at 1 site in South Korea.
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 1 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 18 Sep 2018. 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Ki Woong Sung, MD, PhD (82-2-3410-3529, kiwoong.sung@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of event free survival (time frame: Up to 3 years). 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 18 Sep 2018.