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6.1
Registration Procedures:
6.11
To register a patient, call (555-555-1111) or
fax (555-555-1111) a completed eligibility checklist to
the Randomization Center between 8 a.m. and 4:30 p.m.
central time Monday through Friday.
6.12
IRB approval(s) is required for each treating site and a
signed 310 form(s) is to be on file at the Randomization
Center before patient accrual.
6.13
Patient eligibility and the existence of a signed consent
form will be checked by Randomization Center personnel before
a patient will be registered into this study.
6.14
Treatment on this protocol must commence by the accruing
membership under the supervision of a NCCTG member physician.
6.15
Treatment cannot begin prior to registration and must begin
³7
days after registration.
6.16
Pretreatment tests must be completed within the guidelines
specified on the test schedule.
6.17
Study drug availability checked.
6.18
Patients must be registered separately for the translational
research component of this study.
6.2
Randomization Procedures:
6.21
Patients will be randomized in double-blind fashion (see
Section 6.3) to receive Megace
liquid plus placebo capsule or Marinol capsule plus placebo
liquid or Megace liquid plus a Marinol capsule. Neither
the patient nor the patient's physician will know what treatment
is being given.
6.22
Patients will be stratified at the time of randomization
as outlined in Section 5.0.
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