New chemo combo shows promise for rare sarcoma
NCT ID NCT04605770
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing the combination of two chemotherapy drugs, pemetrexed and cisplatin, in 164 adults with advanced or recurrent soft tissue sarcoma. The goal is to see if this treatment can slow tumor growth in people who have already tried standard therapies. Participants will receive up to 6 cycles of the combination, followed by pemetrexed alone, and will be monitored for response and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pemetrexed and cisplatin (chemotherapy drugs)
- What this could lead to
- If successful, this could provide a new chemotherapy option for people with advanced soft tissue sarcoma who have not responded to standard treatments.
- What could go wrong
- This is an early-phase trial with a small number of participants. The drugs may not work better than existing options, and side effects from chemotherapy can be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 164 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2020
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * histologically confirmed, advanced/metastatic STS * Is ≥ 19 years of age * Eastern Cooperative Oncology Group performance status of 0 or 1 * measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 * laboratory values indicating adequate organ function * a documented postmenopausal woman, or is a premenopausal woman with negative urine or serum pregnancy test * life expectancy ≥ 12 weeks Exclusion Criteria: * previously received more than 2 regimens of cytotoxic chemotherapy * received chemotherapy, surgery to major organ, or radiotherapy within the last 2 weeks * ongoing toxicity (≥ CTCAE grade 2) from previous anticancer therapy * central nervous system (CNS) metastases requiring active treatment * diagnosis of second malignancy or has a history of active malignancy within the past 3 years * other medical conditions where the study treatment is intolerable * history of active infection * hypersensitivity to pemetrexed or any of its excipients * Co-administration with yellow fever vaccine * pregnancy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Severance Hospital
RECRUITINGSeoul, 03722, South Korea
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