Soft Tissue SarcomaNCT04055753
Study to Assess TOPO2A as a Biomarker for Sensitivity to Doxorubicin/Doxil in Soft Tissue Sarcoma
An observational study of Soft Tissue Sarcoma, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
The primary aim of this study is to determine the utility of TOPO2A as a biomarker for sensitivity to doxorubicin or its derivatives. Patients whose planned therapy is doxorucibin or doxil single agent may be enrolled into this trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Doxil and Doxorubicin
- Type of treatment
- Injection or infusion
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2016to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients whose planned therapy is doxorucibin or doxil single agent may be enrolled into this trial.
Who may be able to join
- Patients must consent to providing tumor tissue prior to initiation of therapy if sufficient archival tissue is not available. Archival tissue is permitted if no other anticancer treatment was given after the tissue was obtained (not including surgery or radiation). If a biopsy is required, the treating physician should ensure that this can be done safely.
- Patients with STS will be eligible for the trial if their next planned chemotherapy will include single agent doxorubicin or doxil. Patients who will be receiving concomitant therapy with olaratumab will be allowed to participate.
- Sarcoma subtypes of angiosarcoma, epithelioid sarcoma, leiomyosarcoma, fibrosarcoma, myxofibrosarcoma, synovial sarcoma, pleomorphic rhabdomyosarcoma, undifferentiated pleomorphic sarcoma, liposarcoma (excluding well-differentiated) and malignant peripheral nerve sheath tumor will be included. These are subtypes for which a targeted therapy is not standard of care. All other subtypes will be included on a case by case basis as determined by the principle investigator.
- ≥ 18 years of age.
- Ability to understand and willingness to sign a written informed consent and HIPPA document
- Measurable disease by RECIST 1.1 criteria (at least one target lesion outside of previous radiation fields or progressed within a previous radiation field).
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- Life expectancy of at least 3 months.
- All women of childbearing potential must have a negative serum pregnancy test and all subjects must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose. Post-menopausal women must meet the criteria of 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >35 mIU/ml (IU/L).
- Patients must have normal organ and marrow function as defined below
- Absolute neutrophil count > 1,500/mcL
- Platelets > 100,000/mcL
- Total bilirubin ≤ 1.5 X upper limit of normal (ULN)
- AST/ALT (SGOT/SGPT) ≤ 3 X institutional normal limits; if liver metastases are present then ≤ 5 X ULN are allowed
Who cannot join
- Patients may not be receiving any other investigational agents, chemotherapy, radiation therapy or hormonal therapy (i.e. aromatase inhibitors for leiomyosarcoma), with the exception of olaratumab
- Pregnant or breast feeding women.
- Any concomitant medical issue that in the opinion of the treating physician would confound survival from sarcoma (e.g. other active cancer, symptomatic brain metastases, cardiac conditions).
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: A Study to Assess Topoisomerase II Alpha (TOPO2A) as a Biomarker for Sensitivity to Doxorubicin/Doxil in Soft Tissue Sarcoma
The primary aim of this study is to determine the utility of TOPO2A as a biomarker for sensitivity to doxorubicin or its derivatives. Patients whose planned therapy is doxorucibin or doxil single agent may be enrolled into this trial. In light of its recent FDA approval and differing mechanism of action, patients receiving olaratumab along with doxorubicin will be eligible for this study.
Doxorucibin will be administered at standard 21-day intervals. Doxil will be administered at standard 28-day intervals. Response to therapy will be assessed using standard RECIST criteria every 2 cycles. Patients will continue on study until disease progression, prohibitive toxicity or completion of cumulative dose of 450 mg/m2 of either agent. Overall survival will be assessed every 3 months for 1 year, every 6 months in year 2 and, annually until death.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Doxil, Doxorubicin
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxilDrug
Doxil 50 mg/m2, as per institutional standard
DoxorubicinDrug
Doxorubicin 75 mg/m2, IV over 5-15 min OR Continuous infusion over 48-72 hours
| Study group | Role | What they receive |
|---|---|---|
| Doxorubicin | Not described Receives: Drug: Doxorubicin | |
| Doxil | Not described Receives: Drug: Doxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best overall response
best response recorded from the start of the treatment until disease progression/recurrence
Measured: 6 years
Secondary outcomes (1)
Overall survival
defined as the time from initiation of treatment until death from any cause
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start12 Aug 2016
- Primary completion15 Oct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055753
- Sponsor's protocol ID
- SAR-082
- Status last verified
- May 2026
- First submitted
- 12 Aug 2019
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Topoisomerase II Alpha (TOPO2A) as a Biomarker for Sensitivity to Doxorubicin/Doxil in Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT04055753
- Acronym / sponsor ID
- SAR-082
- Conditions
- Soft Tissue Sarcoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 12 Aug 2016 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 14 Aug 2019 (actual)
- 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 primary aim of this study is to determine the utility of TOPO2A as a biomarker for sensitivity to doxorubicin or its derivatives. Patients whose planned therapy is doxorucibin or doxil single agent may be enrolled into this trial. In light of its recent FDA approval and differing mechanism of action, patients receiving olaratumab along with doxorubicin will be eligible for this study.
Doxorucibin will be administered at standard 21-day intervals. Doxil will be administered at standard 28-day intervals. Response to therapy will be assessed using standard RECIST criteria every 2 cycles. Patients will continue on study until disease progression, prohibitive toxicity or completion of cumulative dose of 450 mg/m2 of either agent. Overall survival will be assessed every 3 months for 1 year, every 6 months in year 2 and, annually until death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxorubicin | – | Drug: Doxorubicin |
| Doxil | – | Drug: Doxil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients whose planned therapy is doxorucibin or doxil single agent may be enrolled into this trial.
Key inclusion criteria (13 listed)
- Patients must consent to providing tumor tissue prior to initiation of therapy if sufficient archival tissue is not available. Archival tissue is permitted if no other anticancer treatment was given after the tissue was obtained (not including surgery or radiation). If a biopsy is required, the treating physician should ensure that this can be done safely.
- Patients with STS will be eligible for the trial if their next planned chemotherapy will include single agent doxorubicin or doxil. Patients who will be receiving concomitant therapy with olaratumab will be allowed to participate.
- Sarcoma subtypes of angiosarcoma, epithelioid sarcoma, leiomyosarcoma, fibrosarcoma, myxofibrosarcoma, synovial sarcoma, pleomorphic rhabdomyosarcoma, undifferentiated pleomorphic sarcoma, liposarcoma (excluding well-differentiated) and malignant peripheral nerve sheath tumor will be included. These are subtypes for which a targeted therapy is not standard of care. All other subtypes will be included on a case by case basis as determined by the principle investigator.
- ≥ 18 years of age.
- Ability to understand and willingness to sign a written informed consent and HIPPA document
Key exclusion criteria (3 listed)
- Patients may not be receiving any other investigational agents, chemotherapy, radiation therapy or hormonal therapy (i.e. aromatase inhibitors for leiomyosarcoma), with the exception of olaratumab
- Pregnant or breast feeding women.
- Any concomitant medical issue that in the opinion of the treating physician would confound survival from sarcoma (e.g. other active cancer, symptomatic brain metastases, cardiac conditions).
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 |
|---|---|---|
| DoxilDoxil 50 mg/m2, as per institutional standard | Drug | Doxil |
| DoxorubicinDoxorubicin 75 mg/m2, IV over 5-15 min OR Continuous infusion over 48-72 hours | Drug | Doxorubicin |
Primary outcome
Best overall response
Time frame: 6 years
best response recorded from the start of the treatment until disease progression/recurrence
1 secondary outcome
Overall survival
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue Sarcoma, run by Fox Chase Cancer Center at 1 site in United States.
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 13 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. 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 United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Best overall response (time frame: 6 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 22 May 2026.