This family protocol summary is about the Children’s Oncology Group study AHEP0731. 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.

AHEP0731 is a Phase III 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 drug or 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?

AHEP0731 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 Always discuss any questions that you may have with your health care team.

Study Number


Study Title

Treatment of Children with All Stages of Hepatoblastoma with Temsirolimus Added to High Risk Stratum Treatment

Study Opening Date

AHEP0731 opened on 9/14/09. The committee hopes to enroll 240 patients. Patients will be treated in 4 different groups (stratums).

General Patient Eligibility

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

General Background and Study Goal

Hepatoblastoma is the most common cancer of the liver in children. When the tumor can be surgically removed, surgery alone has been very successful in curing hepatoblastoma. In children whose tumor cannot be surgically removed or has spread to other areas of the body (metastasized) hepatoblastoma can be harder to cure. For those patients, surgery, chemotherapy drugs (cancer fighting medicines) and for some patients, liver transplant have been used to treat hepatoblastoma.

Specific features of hepatoblastoma have been used to predict how children will respond to therapy. These features include:

Summary of the Treatment

All patients will be assigned to a risk group based on tumor type, staging, and AFP level.

On this study, the treatment of Hepatoblastoma is based on the risk group:

**In October 2014, the study was amended to add the drug Temsirolimus to vincristine and irinotecan for high risk patients.

Special Considerations

Patients classified as Very Low and Low Risk will have their tumor centrally evaluated prior to study enrollment.

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 and nurses are the best sources for further information.

Study Chair

Howard Katzenstein MD


Initial development Name Date
Written by Christie Powell February 28, 2012
Reviewed/approved by (PI) Howard Katzenstein MD June 23, 2016
Ongoing review
Reviewed and updated by Elizabeth Bell January 26, 2016
Christie Powell, CRNP February 8, 2017
February 6, 2018

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