Paclitaxel/Ifosfamide/Cisplatin Chemotherapy for High Risk Pediatric Germ Cell Tumor

  • STATUS
    Recruiting
  • End date
    Jun 29, 2028
  • participants needed
    42
  • sponsor
    Yonsei University
Updated on 4 October 2022

Summary

Germ cell tumor has generally good prognosis, but high risk germ cell tumor has still very poor prognosis. There remains the need of further improvement with other chemotherapy strategy. Especially more than 11 years old, mediastinal germ cell tumor, stage 3 or 4 extragonodal germ cell tumor or the remained tumor after the primary treatment are the group with the poorest prognosis.

Paclitaxel is widely used chemotherapeutic agent in adults and the experience of the agent has also been accumulated in children. The paclitaxel, ifosfamide, cisplatin (TIP) regimen has been used 2nd-line treatment for germ cell tumor and there is some promising result of the role of TIP in first line germ cell tumor treatment. In high risk pediatric germ cell tumor patients, TIP regimen will be able to reduce lung toxicity from the bleomycin as the standard regimen and to improve the survival. In this trial, the efficacy and safety of TIP as the first line treatment for germ cell tumor will be elucidated.

Details
Condition Pediatric Germ Cell Tumor
Treatment TIP treatment (paclitaxel/ifosfamide/cisplatin)
Clinical Study IdentifierNCT05455918
SponsorYonsei University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Over 1 year old and less than 20 years old
Pathologically or cytologically diagnosed germ cell tumor
Germ cell tumor which has not been treated previously
Higher than stage II (stage I should be excluded)
Pathologic type
embryonal carcinoma
choriocarcinoma
yolk sac tumor
teratoma with malignant germ cell tumor elements
High risk definition
More than 11 years old, male or female
Less than 11 years old, male or female
Extragonodal germ cell tumor, stage III
Extragonodal germ cell tumor, stage IV
Ovarian germ cell tumor, stage IV
More than 8 weeks of life expectancy
performance level : ECOG Performance score 0, 1, or 2
informed consent should be obtained

Exclusion Criteria

pregnancy or lactating patients (fertile men or women should agree to avoid pregnancy during the trial period)
previously reported allergy or hypersensitivity to trial chemotherapeutic agent
severe hypersensitivity to the agent containing Cremophor R EL (polyoxyethylated castor oil)
Acceptable organ functions
Bone marrow : Absolute neutrophil count >=1000/µL , platelet >= 100000/µL
Renal function : serum creatinine ≤ 1.5 x upper limit of normal (ULN)
Hepatic function : total bilirubin ≤ 1.5 x ULN, ALT ≤ 3.0 x UNL
Cardiac Function : Ejection fraction ≥ 50%
Uncontrolled infection
Uncontrolled urinary obstruction
Uncontrolled cystitis
Followings will be excluded
Mature teratoma
Gliomatosis Peritonei
Low Risk Germ Cell Tumor
testicular stage I
ovarian stage I
recurrent, refractory tumor
Concomitant other trial agent beside the agents in this trial
Concomitant chemotherapeutic agents besides the agents in this trial
Concomitant tumor other than germ cell tumor
Other trial agents
Other chemotherapeutic agents
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note