Description:

ACNS0122 Eligibility Worksheet NCT00047320 Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BD908887-2F0D-1578-E034-0003BA12F5E7

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https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BD908887-2F0D-1578-E034-0003BA12F5E7

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  1. 8/26/12
  2. 1/9/15
  3. 6/21/15
Uploaded on:

June 21, 2015

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Creative Commons BY-NC 3.0 Legacy
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ACNS0122 Eligibility Worksheet NCT00047320

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  1. StudyEvent: ACNS0122 Eligibility Worksheet
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Header
Eligibility Assessment
Was the patient greater than 3 years of age and less than 25 years of age at diagnosis?
Did the patient have histologic verification of one of the following? -Endodermal sinus tumor (yolk sac tumor); -Embryonal carcinoma; -Choriocarcinoma; -Immature teratoma; -Teratoma with malignant transformation; -Mixed germ cell tumor
Did the patient have any histologically confirmed germ cell tumor with elevation of serum/CSF beta HCG >50 IU/dl or any elevation of CSF alpha fetoprotein >10IU/L
Did the patient have histologically unconfirmed pineal and/or suprasellar tumors with serum/CSF tumor markers of beta>50 IU/dl or any elevation of alpha fetoprotein >10 IU/L?
Was surgery performed?
was a cranial MRI with gadolinium obtained prior to induction or pre-operative and post-operative? (If yes,)
Will the start of treatment begin within 31 days of initial diagnosis and within 7 days from study enrollment?
Karnofsky Performance Score
Lansky Play Score
Does the patient have a life expectancy of more than or equal to 2 months?
Does the patient have a life expectancy of more than or equal to 2 months?
Has patient received prior treatment other than surgery and corticosteriods?
Did patient receive growth hormone therapy?
Does the patient have adequate bone marrow function?
Does the patient have adequate renal function?
Does the patient have adequate Central Nervous System function?
is the patient pregnant and/or breastfeeding? (If female,)
Has the patient and/or their parents or legal guardians signed a written informed consent?
Have all institutional, FDA, and NCI requirements for human studies been met?
Ccrr Module For Acns0122 Eligibility Worksheet