Nab-PTX, Ifosfamide and Cisplatin in the Treatment of Pediatric Extracranial Germ Cell Tumor. (NCT04581265) | Clinical Trial Compass
UnknownPhase 2
Nab-PTX, Ifosfamide and Cisplatin in the Treatment of Pediatric Extracranial Germ Cell Tumor.
43 participantsStarted 2020-11-10
Plain-language summary
The purpose is to evaluate the effectiveness and safety of albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin in the treatment of children patients with advanced, recurrent or refractory extracranial germ cell tumor.
Who can participate
Age range
1 Year – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: 1-18 years old;
. ECOG PS score: 0-1;
. Patients was confirmed pathologically with malignant germ cell tumor.
. Patients with tumor progressed, relapsed or refractory after first-line chemotherapy, and complete or partial remission was not achieved after recent treatment.
. Have at least one measurable lesion defined by RECIST standard;
. The estimated survival time was more than 6 months;
. Patients must fully recover from the acute toxicity of previous anticancer chemotherapy:
. Bone marrow function met the following criteria:
Exclusion criteria
. Patients with recurrent germ cell tumor were treated by surgery alone previously;
. Patients with immature teratoma (any grade);
. Patients with sex cord stroma;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
overall response rate，ORR
Timeframe: From the beginning of observation to the 2 cycles of observation(each cycle is 21 days)