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Prevention study for Ewing Sarcoma
Official title A Prospective, Randomized, Controlled Clinical Study on the Prevention of Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib
ClinicalTrials.gov ID: NCT06699472
What this study is testing
What is Chemotherapy?
Chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ewing sarcoma.
Also referred to as VDC/IE alternating chemotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a prospective, open label, randomized controlled clinical trial aimed at patients with Ewing's sarcoma who have not received systematic anti-tumor treatment in the past. The aim is to evaluate the efficacy and safety of prophylactic use of Trilaciclib before VDC+IE chemotherapy.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 40
You may be able to join if
- Age ≥ 14 years old and ≤ 40 years old;
- Histologically confirmed Ewing's sarcoma;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1;
- Have not received any anti-tumor treatment other than surgery in the past;
- Expected survival of more than 3 months;
You likely can't join if
- Previously received anti-tumor treatment other than surgery and radiation therapy for any malignant tumor;
- people who cannot accept or tolerate this chemotherapy regimen for various reasons;
- Biopsy confirmed a patient with bone marrow infiltration;
- The patient has undergone significant surgical procedures unrelated to Ewing's sarcoma within the 4 weeks prior to enrollment, or has not fully...
- Serious heart disease or discomfort, including but not limited to the following diseases: Diagnosed history of heart failure or systolic dysfunction...
- Individuals with a known history of allergies to the components of this medication regimen;
See the full eligibility criteria
- Age ≥ 14 years old and ≤ 40 years old;
- Histologically confirmed Ewing's sarcoma;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1;
- Have not received any anti-tumor treatment other than surgery in the past;
- Expected survival of more than 3 months;
- Possess sufficient organ and bone marrow function, with laboratory test values meeting the following requirements within 7 days prior to enrollment (no blood components, cell growth factors, albumin, or other corrective...
- For female people of childbearing age, a urine or serum pregnancy test should be conducted 3 days before receiving the first study drug and the result should be negative;
- The people and their sexual partners are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period and within 6 months...
- Previously received anti-tumor treatment other than surgery and radiation therapy for any malignant tumor;
- people who cannot accept or tolerate this chemotherapy regimen for various reasons;
- Biopsy confirmed a patient with bone marrow infiltration;
- The patient has undergone significant surgical procedures unrelated to Ewing's sarcoma within the 4 weeks prior to enrollment, or has not fully recovered from such surgical procedures;
- Serious heart disease or discomfort, including but not limited to the following diseases: Diagnosed history of heart failure or systolic dysfunction (LVEF\ 100bpm, significant ventricular arrhythmias (such as...
- Individuals with a known history of allergies to the components of this medication regimen;
- Breastfeeding female patients, female patients with fertility and positive baseline pregnancy test results, or reproductive age patients who are unwilling to take effective contraceptive measures during the entire trial...
- The researchers believe that the patient is not suitable to participate in any other circumstances of this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.