+-----+-------------------------------------------------+-------------+
| ![] | Department of Health & Human Services           | Public      |
| (me |                                                 | Health      |
| dia | ### PROTOCOL STATUS UPDATE v2.0                 | Service     |
| /im |                                                 |             |
| age |                                                 | National    |
| 1.p |                                                 | Institutes  |
| ng) |                                                 | of Health   |
|     |                                                 |             |
|     |                                                 | National    |
|     |                                                 | Cancer      |
|     |                                                 | Institute   |
|     |                                                 |             |
|     |                                                 | Bethesda,   |
|     |                                                 | Maryland    |
|     |                                                 | 20892       |
+-----+-------------------------------------------------+-------------+

> The Cancer Therapy Evaluation Program (CTEP), National Cancer
> Institute, as a sponsor of clinical trials, reviews the status of each
> clinical trial on an ongoing basis. To help us update our records,
> prioritize resources, and evaluate development plans for each agent,
> please complete the form below to update CTEP on the status and status
> date of your study. **Please e-mail this form to the Protocol and
> Information Office at <PIO@CTEP.NCI.NIH.gov> or Fax to (301)
> 496-9384.**

## Date Sent to PI: Date Sent to PIO: 

> Protocol Title:
>
> NCI Protocol #: Local #: IND #:
>
> Principal Investigator:
>
> *Select one:*
>
> ACTIVE Date:
>
> *Definition: Trial is open to accrual.*
>
> TEMPORARILY CLOSED TO ACCRUAL Date:
>
> Reason:
>
> *Definition: Trial is temporarily not accruing.*
>
> TEMPORARILY CLOSED TO ACCRUAL AND TREATMENT Date:
>
> Reason:
>
> *Definition: Trial is temporarily not accruing and patients are not
> receiving therapy.*
>
> CLOSED TO ACCRUAL, PATIENTS STILL ON TREATMENT Date:
>
> *Definition: The protocol has been closed to patient accrual. Patients
> are still receiving therapy.*
>
> CLOSED TO ACCRUAL, ALL PATIENTS HAVE COMPLETED TREATMENT Date:
>
> *Definition: The protocol has been closed to patient accrual. All
> patients have completed therapy, but patients are still being followed
> according to the primary objectives of the study. No additional
> investigational agents are needed for this study.*
>
> COMPLETED Date:
>
> *Definition: The protocol has been closed to accrual, all patients
> have completed therapy, and the study has met its primary objectives.
> A final study report/publication has been submitted to CTEP.*
>
> ADMINISTRATIVELY COMPLETED Date:
>
> Reason for premature completion:
>
> *Definition: The protocol has been completed prematurely (e.g., due to
> poor accrual, insufficient drug supply, IND closure). The trial is
> closed to further accrual and all patients have completed protocol
> treatment. A final study report is not anticipated.*
>
> Publication Citation: or Publication in Press
>
> PRINTED NAME of person completing this form SIGNATURE (required for
> FAX submissions only)
>
> Phone Number: Date:
>
> **E-mail to <PIO@CTEP.NCI.NIH.gov> or Fax to: (301) 496-9384,
> Attention: Protocol Specialist**