Introduction

This family protocol summary is about the Children's Oncology Group study AGCT1531. It tells who is eligible and gives basic information about the study. More details about the study are in the consent form. You can get this from your oncologist.

AGCT1531 is a Phase 3 clinical trial. A trial is another word for a study. This study (clinical trial) is a therapeutic clinical trial. That means it is done to learn about treatment - its safety and how well it works. The purpose of a Phase III trial is to learn if a new treatment that is known to work in treating a type of cancer is better in some way than the standard treatment. For example, does it have better cure rates, longer control of disease, fewer or less serious side effects, or fewer days in the hospital?

AGCT1531 compares several different treatments. These treatments are called study arms. Usually, one study arm is the standard or the best proven current treatment. The other study arms have some changes or additions. The new treatment is thought to be at least as good as the standard treatment. It is not known if the new treatment will be better than the standard treatment.

In a Phase III trial, each child is assigned to a study arm by a method called randomization. This is a process like flipping a coin that assures that each child has a fair and equal chance of being assigned to any of the study arms. This way the study arms can be compared fairly.

In most clinical trials, we will not know which treatment is better until all of the children taking part in the trial have completed treatment and have been getting checked for several years. If one of the treatments is found to be better or safer than the others while the trial is still going on, the trial will be stopped. All children still in the trial will be given the treatment with the best results when possible.

It is important to understand that participating in a clinical trial is entirely voluntary. The decision about whether or not to participate will not affect the care provided by the health care team in any way. You can find additional information about participation in clinical trials at www.childrensoncologygroup.org. Always discuss any questions that you may have with your health care team.

Study Number

AGCT1531

Official Title

A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

Trial Opening Date

AGCT1531 opened on 5//8/17. The AGCT1531 committee hopes to enroll 1,680 patients.

General Patient Eligibility

Age:

• Low Risk (LR): less than 50 years of age at enrollment
• Standard Risk: less than 25 years of age at enrollment

Diagnosis:

• Low Risk (LR): germ cell tumor that has been completely removed by surgery with no evidence of spread anywhere in the body.
• Standard Risk: the tumor was not completely removed at surgery, or the tumor has spread to other parts of the body, or the tumor markers in the blood are elevated. It is called a "standard risk" tumor because the expectation is very high that the tumor is curable using the best available therapies. This is in contrast to a "poor risk" tumor in which cure is not as certain.

Please consult your doctor to determine whether you or your child may participate in this study.

General Background and Study Goal

A germ cell tumor is a type of cancer that grows in the cells that will become either the egg or the sperm. For this reason, the cancer usually occurs in the ovaries or testes (sex organs or gonads), but can also be found in other parts of your body. When the disease occurs outside of the testes or ovary, it usually found along the midline of the body, in the chest, abdomen, or along the tailbone (coccyx). These tumors are referred to as "extragonadal" tumors.

The goal of the LR arm of this study is to understand if it is necessary to give additional treatment chemotherapy) to patients with LR germ cell tumors. The reason we are doing this study is so that we don't give chemotherapy to children who don't need it because they were cured by the surgical removal of the tumor.. Treatment with anti-cancer drugs can cause harmful effects (side effects) that we are trying to avoid.

The standard way in which we have treated germ cell tumors in the United States has been with a drug called cisplatin (plus 2 other drugs). The goal of SR study is to compare the outcomes of children treated with a drug called carboplatin to children treated with cisplatin with standard risk germ cell tumor. Cisplatin has been known to cause long term side effects such as hearing loss and damage to the kidneys. Our goal is to see if carboplatin is equally effective to cisplatin, and whether it is less toxic.. The SR arm of the study will look at the possibility of decreasing side effects of chemotherapy treatment by replacing cisplatin with another chemotherapy drug called carboplatin. Patients in this study will get either carboplatin or cisplatin (in addition to other chemotherapies), they will not get both.

Summary of the Treatment

Low Risk Treatment:
For LR patients on this study, patients will not get further treatment once their tumor has been surgically removed. Instead, patients will be closely monitored for 2 years with frequent blood tests and scans to see if your tumor comes back (relapses). Patients will also be monitored to see if it spreads to other parts of the body.

If at any time the tumor comes back, patients will be given the option to get chemotherapy and/or a second surgery on the standard risk arms of this study.

Standard Risk Treatment:
Standard Risk patients will receive 1 of 2 different treatment plans.
Patients will be randomized to receive chemotherapy treatment on one of the following arms:

• Arm A: bleomycin, etoposide, and carboplatin (experimental)
• Arm B: bleomycin, etoposide, and cisplatin (standard)

Subjects in both arms will receive supportive therapy to help with the side effects of treatment, and surgery if it is required.

Special Considerations

Standard Risk Treatment:
The use of carboplatin instead of cisplatin may cause more, or different, complications.
The carboplatin treatment that is being studied could be less effective than the current standard treatment.

Risks and Side Effects

Chemotherapy can cause side effects during and after treatment. All patients will be closely monitored for possible side effects of the medicines. All risks and side effects will be explained by your treatment team during the consent process. They can answer any questions that you may have about giving permission for your child to be in the clinical trial or other aspects of care. Please refer to the consent form for a detailed explanation of the side effects associated with the treatment on this study.

Contact Information

Your child's oncologist is the best source for further information.

Study Chair

Dr. A. Lindsay Frazier, MD
Dana-Farber/Harvard Cancer Center

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS