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Chemotherapy for Cancer
Study Summary
This trial is testing how well active surveillance, bleomycin, etoposide, carboplatin or cisplatin work in treating pediatric and adult patients with germ cell tumors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 3 trial • 256 Patients • NCT01005680Trial Design
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Who is running the clinical trial?
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- I am between 11 and 25 years old.I am healthy enough to undergo the treatment outlined in the study without any medical reasons preventing me.I have a low-risk, early-stage testicular cancer without certain aggressive features.I have had chemotherapy with cisplatin or carboplatin for cancer.You receive cancer care at certain hospitals or clinics.I haven't had radiation therapy, except possibly for brain metastases if I'm under 11.I have been newly diagnosed with a stage I germ cell tumor.I have been recently diagnosed with a stage II or higher germ cell tumor.I have not received any systemic therapy for my current cancer.I do not have severe lung problems that prevent me from taking bleomycin.My age does not limit my participation due to my specific cancer type and stage.I am younger than 11 years old.I am aged 11-24 with a specific type of advanced testicular cancer and certain tumor markers.I am aged 11-24 with a specific type of cancer not originating in the gonads.I can care for myself but may not be able to do active work or play.My organs are healthy enough for chemotherapy.My kidney function is good based on recent tests.My bilirubin levels are within the normal range for my age.My cancer diagnosis is not listed among the specific types or stages mentioned.I have a low-risk, stage I ovarian immature teratoma with specific tumor markers.I have a low-risk stage I germ cell tumor in the ovary, testicle, or another area.I am under 11 with a specific type of ovarian, testicular, or extragonadal cancer.I am aged 11-24 with a specific type of ovarian cancer at a certain stage.I agree to use effective birth control during the study.I am between 11 and 24 years old.My cancer is a type of germ cell tumor not originating in the brain.Your blood tests show that you have enough white blood cells and platelets.I am breastfeeding and will receive chemotherapy.I am not pregnant and willing to take a pregnancy test if of childbearing age.My liver tests are within normal limits.My cancer is stage I ovarian immature teratoma or stage I non-seminoma/seminoma.This refers to a specific level of risk in the study.
- Group 1: Arm IV (bleomycin, etoposide, cisplatin)
- Group 2: Low-Risk (observation)
- Group 3: Arm III (bleomycin, etoposide, carboplatin)
- Group 4: Arm I (bleomycin, carboplatin, etoposide)
- Group 5: Arm II (bleomycin, etoposide, cisplatin)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the mortality rate for patients who take Cisplatin?
"Cisplatin has undergone multiple rounds of testing, so it is considered safe and received a score of 3."
Are there other hospitals or research centers participating in this trial in Canada?
"Currently, this study is looking for participants at 100 clinical sites. Some of these locations are in Henderson, Houston, and Hartford. If you enroll in the study, the research team will try to place you at a site close to your home to reduce travel."
For what purpose is Cisplatin most often prescribed?
"Cisplatin is often the go-to medication for treating malignant pleural mesothelioma. That being said, Cisplatin has also shown clinical efficacy when treating other conditions such as advanced head and neck cancer, advance directives, and sarcoma."
To date, how many research subjects have enrolled in this experiment?
"That is correct, this research is currently looking for participants. The study was originally published on May 8th, 2017 and was last edited on October 19th, 2022. They are aiming to enroll 2059 patients from 100 different locations."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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