+--------------+--------------------------+-----------------------------+
| ![](media    | PHASE III TRIAL\         | CLINICAL INVESTIGATIONS     |
| /image1.png) | CONCEPT SUBMISSION,      | BRANCH                      |
|              | Version 2                |                             |
+--------------+--------------------------+-----------------------------+
|              | **National Cancer        |                             |
|              | Institute**              |                             |
|              |                          |                             |
|              | **Division of Cancer     |                             |
|              | Treatment and            |                             |
|              | Diagnosis**              |                             |
|              |                          |                             |
|              | **Cancer Therapy         |                             |
|              | Evaluation Program**     |                             |
+--------------+--------------------------+-----------------------------+

*NOTES: Concepts must be submitted in electronic format (tables or
schema may be converted to .pdf format to assure accurate transfer). To
complete the form electronically, use the mouse pointer or the Tab key
to navigate. Select and enter text for each text field (the
[Insert]{.smallcaps} key must be set to [Off]{.smallcaps}) or follow
instruction when given. Submit by e-mail to PIO@CTEP.NCI.NIH.GOV. Each
of the scientific sections should be sufficient to constitute the
corresponding sections of a final protocol, but they should not be
excessive or encyclopedic. Within these principles as a guide, there are
no specific requirements or limitations on length.*

# I. ADMINISTRATIVE

  -------------------- ------------------------------ ------- ---------------
  Title of Concept:    \[Click here to enter title\]          

  Sponsoring           \[Click here to enter local            
  Organization's Local number\]                               
  Protocol Number:                                            

                                                              

  Study Chair Name     \[Click here to enter name\]           
  (printed):                                                  

  Study Chair                                         Date:   
  Signature                                                   
  (optional):                                                 

  Study Chair Address: \[Click here to enter address          
                       information\]                          

                       \[Click here to enter street           
                       adress\]                               

                       \[Click here to enter city,            
                       state, zip\]                           

  Study Chair Phone:   \[Click here to enter phone            
                       number\]                               

  Study Chair Fax:     \[Click here to enter fax              
                       number\]                               

  Study Chair e-mail:  \[Click here to enter e-mail           
                       address\]                              

  Name(s) of co-chairs \[Click here to enter name\]           
  or discipline                                               
  chairs, if any:                                             

                                                              

  Statistical/Data                                            
  Management Office(s)                                        
  (Must be NIH Funded.                                        
  If not currently                                            
  responsible for                                             
  large scale NCI                                             
  clinical trials,                                            
  submit a separate                                           
  document describing                                         
  data management                                             
  resources to be used                                        
  for the trial, and                                          
  Data Safety and                                             
  Monitoring Board):                                          

  Name of Study        \[Click here to enter name\]           
  Statistician                                                
  (Printed):                                                  

  Signature of Study                                  Date:   
  Statistician                                                
  (optional):                                                 

  Study Statistician   \[Click here to enter address          
  Address:             information\]                          

                       \[Click here to enter street           
                       adress\]                               

                       \[Click here to enter city,            
                       state, zip\]                           

  Study Statistician   \[Click here to enter phone            
  Phone:               number\]                               

  Study Statistician   \[Click here to enter fax              
  Fax:                 number\]                               

  Study Statistician   \[Click here to enter e-mail           
  E-mail:              address\]                              

  NIH Grant Number:    \[Click here to enter grant            
                       number\]                               
  -------------------- ------------------------------ ------- ---------------

If this trial is NOT proposed for activation in the Cancer Trials
Support Unit (CTSU), please provide justification.

> \[Click here to enter justification\]

If this trial is NOT proposed for activation ASAP, planned date for
activation and reason for delay:

> \[Click here to enter date and reason\]

# II. SCIENCE SECTION

*To enter text, click on the blank line [under]{.underline} each
question and type or paste text.*

1.  Specific hypotheses:

2.  Objective(s) (it is preferable to specify one primary objective and
    any number of secondary objectives):

> 2.1 Primary objective:
>
> 2.2 Secondary objective(s):

3.  Background Information. This section should include the following:

> 3.1 Rationale for selected approach and trial design.
>
> 3.2 Discuss why this trial is important (include summary of clinical
> issues and competing study questions relevant to the trial setting)
> and potential impact on, for example, overall survival, quality of
> life or advances in proof of biologic principles. Also, how would
> research strategy or future clinical practice be altered by either
> positive or negative results?
>
> 3.3 All relevant data (include phase 1-3 trial results, and any pilot
> or confidential data from companies that justify the use of the
> control and experimental arms).
>
> (For publications cited, include either the NLM/Medline ID number or
> the URL address to permit retrieval of the full text or abstract by
> reviewers)

4.  Eligibility (include rationales for selecting or excluding
    particular cohorts):

5.  Arms/Regimens (include schema):

    1.  Schema

> 5.2 Arms/Regimens

6.  Statistical design in detail:

> 6.1 Endpoint(s).
>
> 6.1.1 Primary Endpoint
>
> 6.1.2 Secondary Endpoint (if any)
>
> 6.2 Include any stratification to be used in the randomization.
>
> 6.3 Provide sample size with power justification.
>
> 6.4 Provide analysis plan including plans for formal interim analysis.
>
> 6.5 Provide the following accrual information:
>
> Accrual Rate: \[Click here to enter accrual per month\] pts/month.
> (Please provide the justification for this accrual rate estimate. If
> the accrual estimate is based upon participation of other Groups,
> please have them submit letters of endorsement to the CTSU at the time
> of concept submission.)
>
> Total Expected Accrual: \[Click here to enter minimum accrual\] min
> \[Click here to enter maximum accrual\] max

7\. Feasibility (Discuss, as appropriate, size of eligible population,
anticipated acceptance of trial by patients and referring physicians and
experience with accrual to similar trials). Investigators
[must]{.underline} include:

> 7.1 Competing phase 3 trials in your Group.
>
> 7.2 Competing trials in other U.S. or international Groups.
>
> 7.3 Competing company studies of which you are aware.

# III. PHARMACEUTICAL SECTION

1.  Specify the agent(s) to be used in the study:\*

+----------------+------+------+-----------------------+------+------+
| Agent Name     | Req  | Is   | Who is the IND        | NSC\ | Plac |
|                | uest | the  | Holder?               | Nu   | ebo\ |
|                | for  | a    |                       | mber | Con  |
|                | CT   | gent |                       | [^1] | trol |
|                | EP/P | I    |                       |      | led? |
|                | MB-d | nves |                       |      |      |
|                | istr | tiga |                       |      |      |
|                | ibut | -tio |                       |      |      |
|                | ion? | nal? |                       |      |      |
+----------------+------+------+-----------------------+------+------+
| > \[Click here | \[\  | \[\  | > \[\]Company         | \[E  | \[\  |
| > to enter     | ]Yes | ]Yes | > \[\]Consortium      | nter | ]Yes |
| > agent name\] | \[   | \[   | > \[\]CTEP\           | N    | \[   |
|                | \]No | \]No | > \[\]Group           | SC\] | \]No |
|                |      |      | > \[\]Investigator\   |      |      |
|                |      |      | > \[\]Other           |      |      |
|                |      |      | > (Specify):\[Click   |      |      |
|                |      |      | > here to enter       |      |      |
|                |      |      | > holder\]            |      |      |
+----------------+------+------+-----------------------+------+------+
| > \[Click here | \[\  | \[\  | > \[\]Company         | \[E  | \[\  |
| > to enter     | ]Yes | ]Yes | > \[\]Consortium      | nter | ]Yes |
| > agent name\] | \[   | \[   | > \[\]CTEP\           | N    | \[   |
|                | \]No | \]No | > \[\]Group           | SC\] | \]No |
|                |      |      | > \[\]Investigator\   |      |      |
|                |      |      | > \[\]Other           |      |      |
|                |      |      | > (Specify):\[Click   |      |      |
|                |      |      | > here to enter       |      |      |
|                |      |      | > holder\]            |      |      |
+----------------+------+------+-----------------------+------+------+
| > \[Click here | \[\  | \[\  | > \[\]Company         | \[E  | \[\  |
| > to enter     | ]Yes | ]Yes | > \[\]Consortium      | nter | ]Yes |
| > agent name\] | \[   | \[   | > \[\]CTEP\           | N    | \[   |
|                | \]No | \]No | > \[\]Group           | SC\] | \]No |
|                |      |      | > \[\]Investigator\   |      |      |
|                |      |      | > \[\]Other           |      |      |
|                |      |      | > (Specify):\[Click   |      |      |
|                |      |      | > here to enter       |      |      |
|                |      |      | > holder\]            |      |      |
+----------------+------+------+-----------------------+------+------+
| > \[Click here | \[\  | \[\  | > \[\]Company         | \[E  | \[\  |
| > to enter     | ]Yes | ]Yes | > \[\]Consortium      | nter | ]Yes |
| > agent name\] | \[   | \[   | > \[\]CTEP\           | N    | \[   |
|                | \]No | \]No | > \[\]Group           | SC\] | \]No |
|                |      |      | > \[\]Investigator\   |      |      |
|                |      |      | > \[\]Other           |      |      |
|                |      |      | > (Specify):\[Click   |      |      |
|                |      |      | > here to enter       |      |      |
|                |      |      | > holder\]            |      |      |
+----------------+------+------+-----------------------+------+------+
| > \[Click here | \[\  | \[\  | > \[\]Company         | \[E  | \[\  |
| > to enter     | ]Yes | ]Yes | > \[\]Consortium      | nter | ]Yes |
| > agent name\] | \[   | \[   | > \[\]CTEP\           | N    | \[   |
|                | \]No | \]No | > \[\]Group           | SC\] | \]No |
|                |      |      | > \[\]Investigator\   |      |      |
|                |      |      | > \[\]Other           |      |      |
|                |      |      | > (Specify):\[Click   |      |      |
|                |      |      | > here to enter       |      |      |
|                |      |      | > holder\]            |      |      |
+----------------+------+------+-----------------------+------+------+
| > \[Click here | \[\  | \[\  | > \[\]Company         | \[E  | \[\  |
| > to enter     | ]Yes | ]Yes | > \[\]Consortium      | nter | ]Yes |
| > agent name\] | \[   | \[   | > \[\]CTEP\           | N    | \[   |
|                | \]No | \]No | > \[\]Group           | SC\] | \]No |
|                |      |      | > \[\]Investigator\   |      |      |
|                |      |      | > \[\]Other           |      |      |
|                |      |      | > (Specify):\[Click   |      |      |
|                |      |      | > here to enter       |      |      |
|                |      |      | > holder\]            |      |      |
+----------------+------+------+-----------------------+------+------+

*\*For treatment protocols, include only anti-cancer agents.*

2.  If CTEP is being requested to distribute any agents not under a CTEP
    IND, provide the reason for the request for each agent.

> \[Click here to enter reason\]

# IV. EMBEDDED CORRELATIVE STUDY SECTION (if applicable) -- Example: companion laboratory or imaging studies, or quality of life studies

*To enter text, click on the blank line [under]{.underline} each
question and type or paste text. If additional space is required, please
include as an attachment.*

1\. Correlative study title:

> 1.1 Correlative study design (to include methods for obtaining
> samples, administering forms, or performing radiologic studies):
>
> 1.2 Specific hypotheses (include relevant background studies):
>
> 1.3 Statistical design (for each correlative study -- include
> endpoints, sample size and monthly accrual rate):

2\. Correlative study title:

> 2.1 Correlative study design (to include methods for obtaining
> samples, administering forms, or performing radiologic studies):
>
> 2.2 Specific hypotheses (include relevant background studies):
>
> 2.3 Statistical design (for each correlative study -- include
> endpoints, sample size and monthly accrual rate):

3\. Correlative study title:

> 3.1 Correlative study design (to include methods for obtaining
> samples, administering forms, or performing radiologic studies):
>
> 3.2 Specific hypotheses (include relevant background studies):
>
> 3.3 Statistical design (for each correlative study -- include
> endpoints, sample size and monthly accrual rate):

# V. PERSON COMPLETING CONCEPT SUBMISSION 

+--------------------+-----------------------------+---+--------------+
| Name of Person     | \[Click here to enter       | D | \[Click here |
| Completing Form:   | name\]                      | a | to enter     |
|                    |                             | t | date\]       |
|                    |                             | e |              |
|                    |                             | : |              |
+--------------------+-----------------------------+---+--------------+
| Person Completing  | \[Click here to enter       |   |              |
| Form Address:      | address information\]       |   |              |
+--------------------+-----------------------------+---+--------------+
|                    | \[Click here to enter       |   |              |
|                    | street adress\]             |   |              |
+--------------------+-----------------------------+---+--------------+
|                    | \[Click here to enter city, |   |              |
|                    | state, zip\]                |   |              |
+--------------------+-----------------------------+---+--------------+
| Person Completing  | \[Click here to enter phone |   |              |
| Form Phone:        | number\]                    |   |              |
+--------------------+-----------------------------+---+--------------+
| Person Completing  | \[Click here to enter fax   |   |              |
| Form Fax:          | number\]                    |   |              |
+--------------------+-----------------------------+---+--------------+
| Person Completing  | \[Click here to enter       |   |              |
| Form E-mail:       | e-mail address\]            |   |              |
+--------------------+-----------------------------+---+--------------+
| NOTE: Concepts     |                             |   |              |
| must be submitted  |                             |   |              |
| in electronic      |                             |   |              |
| format by e-mail   |                             |   |              |
| to                 |                             |   |              |
| PI                 |                             |   |              |
| O@CTEP.NCI.NIH.GOV |                             |   |              |
| using Word95 or    |                             |   |              |
| WordPerfect for    |                             |   |              |
| Windows 7.0 or     |                             |   |              |
| higher.            |                             |   |              |
|                    |                             |   |              |
| > Questions?       |                             |   |              |
| > Please contact   |                             |   |              |
| > the Concept      |                             |   |              |
| > Coordinator at:  |                             |   |              |
| >                  |                             |   |              |
| > Protocol and     |                             |   |              |
| > Information      |                             |   |              |
| > Office,          |                             |   |              |
| > CTEP/DCTD/NCI    |                             |   |              |
| >                  |                             |   |              |
| > Attention:       |                             |   |              |
| > Concept          |                             |   |              |
| > Coordinator      |                             |   |              |
| >                  |                             |   |              |
| > 6130 Executive   |                             |   |              |
| > Boulevard, EPN   |                             |   |              |
| > Room 7000        |                             |   |              |
| >                  |                             |   |              |
| > Rockville, MD    |                             |   |              |
| > 20892            |                             |   |              |
| >                  |                             |   |              |
| > E-mail:          |                             |   |              |
| > [pio@ctep.n      |                             |   |              |
| ci.nih.gov](mailto |                             |   |              |
| :loi@tech-res.com) |                             |   |              |
| > Phone: (301)     |                             |   |              |
| > 496-1367 Fax:    |                             |   |              |
| > (301) 496-9384   |                             |   |              |
+--------------------+-----------------------------+---+--------------+

[^1]: The NSC Number must be provided if the agent is investigational.
    See [http://ctep.cancer.gov/guidelines/codes.html]{.underline} for a
    complete list of Organization (Group, Consortium and Institution),
    IND and NSC Numbers and Disease Names and Codes.