PBTC Concept Submission Form 2009

PBTC Concept Submission Form 2009 - PHASE I, II, or I/II...

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PHASE I, II, or I/II LETTER OF INTENT Submission Form v2.0 National Cancer Institute Division of Cancer Treatment and Diagnosis Cancer Therapy Evaluation Program To complete the form electronically, use the mouse pointer or the Tab key to navigate. Select and enter text for each text field. To easily see text fields, go to Tools|Options from Word’s menu, click the View tab, and in the Show block select ‘ Always’ from the Field Shading drop down list. Lead Group/Institution: [Click here to enter Organization] Lead Institution/Group CTEP ID: 1 [Click here to enter Group/Institution Code] Other Institutions/Groups on study: [Click here to enter other Organizations] Title of LOI: [Click here to enter Title] Agent(s) supplied by NCI: 1 [Click here to enter Agent] Commercial Agents in Study: [Click here to enter Commercial Agents] Tumor Type: (Click within the [[ ]] and type ‘x’ to indicate the tumor type) [[ ]] Solid Tumor [[ ]] Hematologic Malignancy (NOS) [[ ]] Disease-Specific Disease-Specific: 1 (Specify the Name and Code of the Study Disease) 1. [Click and enter Disease Name] [Click and enter Disease Code] 2. [Click and enter Disease Name] [Click and enter Disease Code] 3. [Click and enter Disease Name] [Click and enter Disease Code] Performance Status: [Click and enter Status] Abnormal Organ Function Permitted? [Click and enter Y or N] Prior Therapy: [Click and enter Prior Therapy] Phase of Study: [Click and enter Study Phase] Treatment Plan: [Click and enter Plan] Rationale/Hypothesis: [Click and enter Rationale] Laboratory Correlates: [Click and enter Lab] Endpoints/Statistical Considerations: [Click and enter Endpoints] Estimated Monthly Accrual: [Click and enter Accrual] Proposed Sample Size: Minimum: [Click and enter Size] Maximum: [Click and enter Size] Earliest date the study can begin: [Click and enter Date] Projected Accrual Dates: (Month/Year format) Start: [Enter Month] / [Enter Year] End: [Enter Month] / [Enter Year] To document accrual rate, list trials with If more than one trial is similar, copy and paste the row below to the end of the form, then 1 Detailed Institution, Group, Agent NSC, and Disease codes are available on the CTEP Home Page at http://ctep.cancer.gov/protocolDevelopment/codes_values.htm 31-LOI Submission Form Revised 12/01/2008 Page 1 of 3
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patients who had similar Tumor Type/Phase of Study/Prior Therapy: add the additional study information. Protocol Number / Title / Sponsor : Trial Activation / Trial Completion Dates: No. of Patients Enrolled:* [Click and enter Number] / [Click and enter Title] / [Click and enter Sponsor] (Include NCI Number if NCI-sponsored) [Click and enter Activation Date] / [Click and enter Completion Date] [Click here to enter Pt. Number] (*Entire study or to date, if study is not completed. Only include patients enrolled at site(s) relevant to LOI proposal) List all Active, Approved, or In Review studies at your institution for which this patient population will be eligible: If more than one trial is similar, copy and paste the row below to the end of the form, then
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PBTC Concept Submission Form 2009 - PHASE I, II, or I/II...

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