Below is a list of Germ Cell Tumors clinical trials from the clinical trials database at Mayo Clinic.
This list includes only trials about which Mayo researchers choose to publish information. Mayo Clinic may be conducting other trials which are not in this database. Mayo's clinical trials include experimental treatments, often unavailable elsewhere, which frequently lead to improved patient care for people worldwide. Patients should ask their doctor at Mayo about clinical trials appropriate for their situation.
A Phase 3 Study of Reduced Therapy in the Treatment of Children with Low and Intermediate Risk Extracranial Germ Cell Tumors
This study is being done to:
- Avoid chemotherapy in low risk testicular/ovarian germ cell tumors by using surgery and observation, and using chemotherapy only if the tumor comes back.
- Lower the total amount of chemotherapy cycles given (three times instead of four)
for those patients getting chemotherapy and find out the effects, good and/or bad.
- Lower the number of days over which the chemotherapy is given from five to three days.
A secondary goal of the study is to understand the biology of germ cell tumors better.
Researchers would like to know more about the genetic factors that affects the development of germ cell tumors.
Patients are being asked to take part in this study because they have been told that they have a germ cell tumor. A germ cell tumor is a type of cancer that happens in the ovaries (for females) or the testes (for males). This tumor may also be found in other areas of the
body such as the brain, chest or abdomen.
A germ cell tumor is considered low risk when it is present only in the testes or ovaries and is completely taken out by surgery.
A germ cell tumor is considered intermediate risk when:
- It is present only in the testes or ovary, but is not completely taken out by surgery.
- It is present in the testes or ovary and has spread to the lymph nodes or other organs.
- It is present only at one site outside the ovaries or testes, but may or may not be completely taken out by surgery.
The term, risk, refers to the chance of the cancer coming back after treatment.
The standard treatment for patients who have low risk testicular tumors is surgery to take out the tumor and observation; the standard treatment for patients with low risk ovarian tumors is surgery plus chemotherapy (cancer-fighting drugs) given for four cycles (with five days for each cycle of treatment).
The standard treatment for patients with intermediate risk germ cell tumors is surgery plus chemotherapy given for four cycles (with five days for each cycle of treatment).
Germ cell tumors are rare, and account for only 3 percent of all childhood cancers. However, the survival rate for patients with these types of tumors is very high at 95 percent for low risk tumors and 93 percent for intermediate risk tumors.
The standard treatment for germ cell tumors is very effective. Study doctors would like to know if it is possible to lower the side effects from chemotherapy treatment. Side effects are unintended or unwanted results. When chemotherapy is lowered, there have been fewer side effects from chemotherapy. This study will test if lowering the amount of chemotherapy given to intermediate risk tumor patients and not giving chemotherapy to low risk patients will result in the same high survival rate.
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