RFP ATTACHMENT 3

RFP S06-285

# Standard Cancer Center Information Summaries

The following Summaries and formats prescribe the information required
and the format for presentation in response to the RFP.

**[Summary 1: Reportable Patients/Participation in Therapeutic Protocols
By Anatomic Cancer Site]{.underline}**

This Summary documents which anatomic cancer sites are being treated at
the cancer center and whether the center is placing these patients onto
therapeutic protocols for each site. Broadly, it summarizes the clinical
research activities of the cancer center. For clarity and uniformity,
use the following definitions:

> **Reporting Period:** Three 12-month periods; three tables can be
> provided in the same format, and provide a total for each of the three
> periods.
>
> **Reportable Patients:** Reportable patients are those seen
> face-to-face and *first registered* at the cancer center, whether as
> inpatients or outpatients, *during the reporting period*. All patients
> registered should be counted regardless of whether they have a newly
> diagnosed cancer or have recurrent disease and were referred to the
> cancer center for further evaluation and primary or secondary
> treatment occurring after the start date of the reporting period. This
> category *excludes* consults (e.g., for service or second opinions),
> diagnoses at autopsy, and former patients admitted for rehabilitation
> purposes or treatment of some other conditions. It also excludes
> patient follow up activities after treatment is completed.
>
> Reflect the number of *patients* coming to the cancer center, not the
> numbers of visits. *Do not include any patient more than once unless
> they have two malignancies diagnosed in the same year*.

Provide the total number of newly registered reportable patients by
anatomical site of cancer for the selected reporting period, using the
definitions above, and also the number of patients referred to
NCI-designated cancer centers.

**Sample Format Summary 1: Reportable Patients/Participation in
Therapeutic**

**Protocols By Anatomic Cancer Site**

**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Community Cancer Center**

**Reporting Period 1/1/200x -- 12/31/200x**

*Insert Name of Reporting Source*

  ------------------------------------------------------------------------
  **Disease Site *(create separate rows as  **Newly      **No. Pts.
  necessary)***                             Registered   Referred to
                                            Patients**   NCI-Designated
                                                         Cancer Centers**
  ----------------------------------------- ------------ -----------------
  Head and Neck (lip, oral cavity, pharynx,              
  eye, orbit)                                            

  Digestive System (esophagus, stomach,                  
  small intestine, colon, rectum, anus,                  
  liver, pancreas)                                       

  Respiratory (nasal/sinus, larynx,                      
  lung/bronchus)                                         

  Blood and Bone Marrow (leukemia, multiple              
  myeloma, other)                                        

  Bone (Primary)                                         

  Connective Tissue                                      

  Melanoma                                               

  Other Skin Cancer                                      

  Breast Cancer (male and female)                        

  Female Genital (cervix, ovary, other)                  

  Male Genital (prostate, other)                         

  Urinary System (kidney, bladder, other)                

  Brain & CNS (benign, malignant, other)                 

  Endocrine System (thyroid, other)                      

  Lymphatic System (NHL, Hodgkin's                       
  lymphoma)                                              

  Unknown Primary                                        

  Other/Ill-defined                                      

  **TOTAL:**                                             
  ------------------------------------------------------------------------

**[Summary 2: Information on Clinical Research Studies]{.underline}**

> Using the example format, produce a report of the clinical research
> studies open at any time during the reporting period at the cancer
> center during the defined reporting period.
>
> **Reporting period:** Define three 12-month periods for which data are
> being provided.
>
> **Trial Sponsor:** Identify the sponsor as NCI or Other.
>
> **Anatomic Site (Site):** Identify the anatomic cancer site(s) (e.g.,
> breast, ovary) on which the trial or study is focused. If a
> feasibility or early phase trial or other clinical study is broadly
> applicable to a number of potential anatomic sites, enter the term
> "multiple" in this column.
>
> **Title:** Provide a concise title for this trial or study limited to
> 100 characters or fewer.
>
> **Date Opened:** Provide the date that this protocol or study was
> opened to accrual or initiated at the center.
>
> **Date Closed:** If the protocol or clinical research study was closed
> to accrual or completed at the center during the 12-month reporting
> period, provide the date it was closed.
>
> **Trial/Study Type (Type):** Identify the type of trial or clinical
> research study as Behavioral, Therapeutic, or Prevention.
>
> **Total Accrual:** Provide the number of patients accrued to each
> protocol, and also a total for the 12-month reporting period.
>
> **Accrual Rate:** Calculate the accrual rate for each of the 12-month
> periods. Take the number of patients accrued to trials for the
> 12-month period and divide by the number of new cancer cases for the
> same period and multiply by 100.

**Sample Format Summary 2: Information on Clinical Research Studies**

**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Community Cancer Center**

**Reporting Period: 1/1/200x - 12/31/200x**

  --------------- ---------- ----------------- ---------- ---------- --------------- ----------- ----------- ----------- -----------
  **Sponsor       **Site**   **Title**         **Date\    **Date\    **Type          **Accrual   **Accrual   **Accrual   **Total
  (NCI/Other)**                                Opened**   Closed**   (Behavioral,    Year 1**    Year 2**    Year 3**    Accrual**
                                                                     Therapeutic,                                        
                                                                     Prevention)**                                       

  GOG             Cervix     Evaluation of     1/25/04                               3           1           0           4
                             Gemcitabine in                                                                              
                             Persistent or                                                                               
                             Recurrent                                                                                   
                             Non-Squamous Cell                                                                           
                             Carcinoma of the                                                                            
                             Cervix                                                                                      

  ECOG            Bladder    Study of          1/17/05                               0           4           2           6
                             Paclitaxel plus                                                                             
                             Carboplatin in                                                                              
                             patients with                                                                               
                             advanced                                                                                    
                             carcinoma of the                                                                            
                             bladder                                                                                     

                                                                                                                         

                                                                                                                         

  **TOTAL**                                                                          **3**       **5**       **2**       **10**
  --------------- ---------- ----------------- ---------- ---------- --------------- ----------- ----------- ----------- -----------

  ----------------------------- ------------ ---------------- ------------
  **Accrual Rate Calculation**  **Total      **Number of New  **Percent
                                Accrued**    Cancer Cases**   Accrual**

  Period 1: (insert dates)                                    

  Period 2:                                                   

  Period 3:                                                   
  ----------------------------- ------------ ---------------- ------------

#### 

#### [Summary 3: Active NCI-Funded Projects]{.underline}

List all of the projects supported by the NCI during the past three
years, and include a breakdown of the direct and total costs (direct
plus indirect costs).

**Sample Format Summary 3: Active NCI-Funded Projects**

**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Community Cancer Center**

**Reporting Date: xx/xx/200x**

  --------------------------------- -------------- ---------- ---------------
  **Project Title**                 **Dates of     **Direct   **Total Costs
                                    Project**      Costs**    (Dir+Indir)**

  Project 1                         1/2005 --                 \$3,000
                                    12/2006                   

  Project 2                                                   \$25,000

  Project 3                                                   \$500,000

  ...                                                         

  ...                                                         

  **Grand Total (All Projects)**                              **\$528,000**
  --------------------------------- -------------- ---------- ---------------