This lay summary is intended to provide a general overview of the Children’s Oncology Group study ACCL05C1. It will provide information about the children that are eligible for this study and basic information regarding the specifics of the study. The informed consent and protocol contain the full details of the study. Those documents are available to you from your oncologist.

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 healthcare team in any way. You can find additional information about participation on clinical trials on Always discuss any questions that you may have with your healthcare team.

Brief Title: ACCL05C1: A study measuring hearing in patients receiving cisplatin chemotherapy.

Official Title: ACCL05C1: A group-wide, prospective study of ototoxicity assessment in children receiving cisplatin chemotherapy.

Trial Opening Date: May 7, 2007. A total of 150 eligible patients will take part in this study, and should take 2 years to enroll this number of patients.

General Patient Eligibility:

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

Patient Age: 0-30 years of age

For patients:

  • who are receiving any cisplatin chemotherapy, on any protocol, for any disease

Other major enrollment criteria:

  • enrollment prior or within 5 days of starting cisplatin chemotherapy

Patients with the following may not be eligible:

  • prior treatment with cisplatin

General Background and Study Goal

When people are being treated for cancer they receive chemotherapy drugs that can cause hearing loss. It is standard care to have hearing tests on a regular basis to monitor for hearing loss. The standard type of hearing tests is called conventional audiometry. In this study, researchers want to learn more about evaluating for hearing loss by looking at conventional audiometry in different ways and by using two new types of hearing tests. These two new tests are called ultrahigh frequency (UHF) audiometry and otoacoustic emission and are more sensitive to measuring hearing loss than conventional tests.

The goals of this study are:

  • To determine the best way to recognize hearing loss.
  • To determine if it is possible to use two hearing tests, ultrahigh frequency (UHF) audiometry and evoked otoacoustic emission (OAE), as extra tests to measure hearing loss.
  • To have the researchers review the results of all the hearing tests done on patients in this study. This process is called central review. It allows researchers to evaluate the quality of the tests done at all the hospitals taking part in this study.

Summary of the Treatment

For patients receiving standard chemotherapy

  • baseline hearing tests before chemotherapy
  • a hearing test before each cisplatin treatment
  • a hearing test 4 weeks after last cisplatin treatment

For patients receiving a hematopoetic progenitor cell transplant

  • baseline hearing test before the transplant procedure
  • a hearing test 4 weeks after the transplant procedure

Contact Information

Your child’s oncologist is the best source for further information. Physicians with eligible patients should refer questions to the principal investigator:

Principal Investigator Lillian Sung, MD, PhD
Division of Haematology/Oncology
The Hospital for Sick Children
555 University Avenue
Toronto, Ontario M5G 1X8
Phone: (416) 813-5287
Fax: (416) 813-5979
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

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