Pemetrexed, Cisplatin With Soft Tissue Sarcoma

A Single-Arm, Multicenter, Open-Label, Phase 2 Study of Pemetrexed/Cisplatin Chemotherapy for Patients With Metastatic/Recurrent Soft Tissue Sarcoma in 4- Independent Histologic Subtypes

Pemetrexed, Cisplatin With Soft Tissue Sarcoma (NCT04605770) is a Phase 2 interventional studying Sarcoma,Soft Tissue, sponsored by Yonsei University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Soft tissue sarcoma (STS) is rare malignancy of mesodermal origin, representing less than 1% of all malignant neoplasms. They are a group of diseases encompassing diverse histological subtypes with very different biomorphologies, prognoses, and responses to treatments. At advanced stages of STS, anticancer treatments are less effective and the prognosis is poor with a median survival of 8 to 18 months. Doxorubicin and ifosfamide given each alone or in their combination have represented the mainstream of anticancer treatments in metastatic STS. However, salvage treatments for patients with progression after doxorubicin/ifosfamide-based treatment are limited and anticancer agents such as gemcitabine/docetaxel, pazopanib, eribulin and trabectedin are currently used as a standard of care (SOC). For metastatic sarcoma, a study of pemetrexed alone in patients with refractory STS who have progressed after doxorubicin and/or ifosfamide-based anticancer treatment was conducted. In this study including 48 patients, most of whom had relatively poor course of disease with disease progression after the 2nd- and/or 3rd-line treatment, pemetrexed was well tolerated and associated with 5% of response rate and 33% of 3-month progression-free rates suggesting potential antitumor efficacy with good tolerability profile with refractory STS. However, as conventional agents have showed different efficacy depending on various subtypes of STS, a confirmatory study to see clinical utilities of a given regimen by subtype is required also for pemetrexed/cisplatin. Therefore, the investigators intend to proceed this phase 2 clinical trial to evaluate the efficacy and safety of pemetrexed/cisplatin combination therapy in patients with advanced/metastatic STS who received up to two-lines of prior palliative anticancer treatments with histological subtype-specific cohorts (leiomyosarcoma, synovial sarcoma, malignant peripheral nerve sheath tumor, and others) in order to provide a basis for a subsequent phase 3 study by selecting histological subtype(s) in which the efficacy of study regimen is to be proven.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Sarcoma,Soft Tissue and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 164 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Sarcoma,Soft Tissue subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - diagnosed by tissue sample (biopsy-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 your organs (liver, kidneys, etc.) are working well enough based on blood tests - a documented postmenopausal woman, or is a premenopausal woman with negative urine or serum pregnancy test - life expectancy ≥ 12 weeks Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

pemetrexed+cisplatin

Pemetrexed 500 mg/m2 (Day 1) and cisplatin 75 mg/m2 (Day 1) will be given via intravenous (IV) infusion. Each cycle consists of 21 days, and this combination therapy will be continued until Cycle 6. Starting from Cycle 7, pemetrexed alone will be administered every 3 weeks (Q3W) as IV infusion until disease progression. Vitamin B12 1000 mcg intramuscular (IM) injection will be given within 14 days prior to the first dose of pemetrexed, every 9 weeks (on the same day as study treatment) thereafter, and then 21 days after the last dose of pemetrexed. Folic acid 1 mg will be administered daily starting from 14 days before the first dose of pemetrexed and continued until 21 days after the last dose of pemetrexed. Study treatment will be continued until PD, unacceptable AE, or decision to discontinue by subject or physician.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Severance Hospital

Seoul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04605770), the sponsor (Yonsei University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04605770 clinical trial studying?

Who can participate in NCT04605770?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04605770?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04605770. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04605770. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.