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Late Effects of Treatment in Survivors of Pediatric Sarcomas

7 Years
Not Enrolling

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Trial Information

Late Effects of Treatment in Survivors of Pediatric Sarcomas

Childhood cancers mark a relatively infrequent disease entity with an annual age adjusted
rate in children age 0-14 years of 14 per 100,000. Over the last 30 years a striking
increase in survival due to improved diagnosis and aggressive treatment approaches has
vastly enhanced the outlook in this patient population. 75% of children under 15 years age
of can be expected to survive the diagnosis of cancer for more than 5 years. However,
reports of improved survival have been followed by increasing awareness of a multitude of
long-term treatment-related side effects, in addition to an overall death rate 9.6 times
higher than in the sex- and age-matched general population. Over the last 35 years,
patients with pediatric sarcomas have been treated in the Pediatric Oncology Branch (POB) of
the National Cancer Institute. Since 1971 adriamycin and cyclophosphamide in escalating
doses have been incorporated in all multimodality treatment protocols. Ifosfamide became an
integral part of therapy in 1986. The survival rate of patients with these diseases has
improved over this period of time. Accordingly there exists a group of long-term survivors
of therapy employed in a series of POB sarcoma protocols who represent a valuable source of
information on treatment-associated late-effects, e.g. cardiotoxicity, gonadal dysfunction,
growth delay and stress-related neuroendocrine abnormalities. In addition there may be
evaluable rehabilitative impairments and alterations in psychosocial behavior that may only
manifest over time, and prove to be characteristic for this population. This protocol will
systematically enumerate and describe the incidence and extent of treatment related
long-term toxicities in this patient population.

Inclusion Criteria


Diagnosis of sarcoma.

Previous enrollment on one of the POB protocols or enrollment on the Natural History
protocol and treated according to POB outlines for the treatment of sarcomas.

Chemotherapy delivered according to one of previous POB trials.

Patients must be either in first continued remission from sarcoma after completion of
therapy, or in continued remission of more than 5 years after completion of salvage
therapy for disease relapse.

Patients must have had no chemotherapy, radiation therapy, cancer related surgery and/or
immunotherapy for at least 24 months.

Patients must have had stable disease greater than 24 months or be NED by history.

Must be able to travel to NCI/POB. Alternatively, subjects may consent on a separate
consent document to the mail-in questionnaire component of the study only, which will not
require travel to the NIH.

Must be able to understand and sign consent. Minors must be accompanied by a parent or
guardian legally permitted to give consent. Written assent will be obtained from all
minors age 12 years or older.

Patients who elect to complete the mail-in questionnaire must be greater than or equal to
18 years old.

Negative pregnancy test in all female patients. Pregnant or lactating women are
ineligible for study enrollment while they are pregnant or lactating, but may be enrolled
at a later point once these conditions have ceased to exist. For eligible subjects
consenting to participation in the mail-in questionnaire component of the study only, a
urine pregnancy test will not be required.

Type of Study:


Study Design:



United States: Federal Government

Study ID:




Start Date:

November 2000

Completion Date:

November 2011

Related Keywords:

  • Sarcoma
  • Pediatric
  • Sarcoma
  • Effects
  • Survivors
  • Pilot
  • Sarcoma



National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892