Actively Recruiting
A Prospective, Randomized, Controlled Clinical Study on the Prevention of VDC/IE Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib
Led by Fudan University · Updated on 2024-11-21
22
Participants Needed
1
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of using Trilaciclib to prevent chemotherapy-related myelosuppression in patients with Ewing's sarcoma who have not previously received systemic anti-tumor treatment. This is a phase 2, prospective, randomized, controlled clinical trial focusing on patients aged 14 to 40 years with confirmed Ewing's sarcoma. The study compares the use of Trilaciclib combined with standard VDC+IE chemotherapy versus chemotherapy alone. Participants will be randomly assigned to one of two groups: the experimental group receiving Trilaciclib along with alternating VDC+IE chemotherapy every 3 weeks for up to 17 cycles, or the control group receiving only the alternating VDC+IE chemotherapy on the same schedule. The chemotherapy regimen includes vincristine, doxorubicin (or actinomycin D after a certain cumulative dose), cyclophosphamide, ifosfamide, and etoposide. Trilaciclib is given as an intravenous infusion following chemotherapy administration in the experimental group. Supportive care is allowed in both groups as needed. During the treatment, participants will be monitored for myelosuppression effects such as neutropenia and thrombocytopenia through laboratory tests. The primary outcome measures how long severe neutropenia lasts in the first treatment cycle, with additional outcomes tracking recovery times, incidence of febrile neutropenia, anemia, and serious infections across multiple cycles. The study will also assess event-free survival up to 24 months. Treatment continues until disease progression, unacceptable side effects, or withdrawal. The total study duration includes up to 17 cycles of treatment and follow-up assessments.
CONDITIONS
Brief Title
A Prospective, Randomized, Controlled Clinical Study on the Prevention of Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 14 to 40 years old
- Histologically confirmed Ewing's sarcoma
- ECOG Performance Status score of 0 to 1
- No prior anti-tumor treatment except surgery
- Expected survival over 3 months
- Adequate organ and bone marrow function with specific lab test values within 7 days before enrollment
- Negative pregnancy test for females of childbearing age before first treatment
- Use of medically approved contraception during treatment and for 6 months after
You will not qualify if you...
- Prior anti-tumor treatment other than surgery or radiation for any cancer
- Inability to tolerate the chemotherapy regimen
- Bone marrow infiltration confirmed by biopsy
- Recent major surgery unrelated to Ewing's sarcoma within 4 weeks or incomplete recovery
- Serious heart disease or uncontrolled heart conditions
- Known allergies to study medications
- Breastfeeding or positive pregnancy test in females of reproductive age not using contraception
- Any other condition deemed unsuitable by researchers for study participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 51 weeks (17 cycles of 3 weeks each)
Participants receive alternating VDC+IE chemotherapy every 3 weeks combined with Trilaciclib or chemotherapy alone for up to 17 cycles or until disease progression or intolerable toxicity occurs.
Repeated visits every 3 weeks for each treatment cycle
Duration - Up to 24 months
Participants are monitored for disease progression or survival outcomes for up to 24 months after randomization.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cencer Center,
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
X
Xin Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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