Contents

Purpose

Record details of prior therapies related to the disease being studied by the BTTC protocol. Also record any details that the investigator deems to be clinically significant for the evaluation of this study (if noted on the Prior Treatment Summary CRF).

Prior Therapy Supplement eCRF

Field Name

Description / Instructions

Format

Visit Date(m)

Enter the date the form was completed (i.e. the date information was gathered).

DD-MMM-YYYY

No of Prior RegimensEnter the number counting the total regimens of any therapy the patient received prior to enrolling the current protocol, where multiple drugs or a staged therapy count as a single regimen.

2 digits

Date of First Dose(m)

Enter the date of the first dose of the prior therapy. Partial dates are acceptable when the day is not known.

DD-MMM-YYYY or MMM-YYYY

Date of Last Dose

Enter the date of the last dose of the prior therapy. Partial dates are acceptable when the day is not known. Leave it blank if the treatment is currently being received. “Ongoing’ will be reported to CTMS or CDS.

DD-MMM-YYYY, MMM-YYYY

Therapy Type(m)

Select the appropriate type of prior therapy:

  • Anti-Retroviral Therapy
  • Antisense
  • Bone Marrow Transplant
  • Chemotherapy (NOS)
  • Chemotherapy multiple agents systemic
  • Chemotherapy non-cytotoxic
  • Chemotherapy single agent systemic
  • Gene Transfer
  • Hormonal Therapy
  • Drug and/or Immunotherapy

  • Immunotherapy

  • Oncolytic Virotherapy
  • Vaccine
  • Prior Therapy (NOS)
  • Hematopoietic Stem Cell Transplantation
  • Image Directed Local Therapy
  • No prior Therapy
 

Agent Name

Select the generic name of the agent that was used.

Note: For standard regimen (multiple agents given as one regimen), enter one record for each agent.

Use pick list.

Systemic Therapy Relapse Date

Enter calendar date of return of disease following systemic therapy with a period of improvement or complete remission.

DD-MMM-YYYY

Non-Response Therapy Type

Select the therapy type for which the conventional response calls are not appropriate.
AJ - Adjuvant Therapy
PA - Palliative Therapy
NJ - Neoadjuvant Therapy
PR - Prophylaxis
DF - Definitive

Use pick list.

Therapy Intent

Select text term to represent the anticipated outcome that is intended or that guides the delivery of a treatment plan.

  • ADJUVANT

  • RELAPSE

  • RADIOSENSITIZER

  • RADIOSENSITIZER THEN ADJUVANT

  • UNKNOWN

Use pick list.

Regimen Type

Select the term to describe the number of agents included in therapy regimen.

  • MULTIPLE AGENTS

  • SINGLE AGENT

  • UNKNOWN

Use pick list.

Legend: (m) RDC mandatory

Validations

Code

Description

Resolutions

PTS01

Date of First Dose is greater than Date of Last Dose.

Enter a Date of First Dose that is equal to or earlier than the Date of Last Dose.

PTS02,
PTS03

Date of First Dose and Date of Last Dose are in the future.

Enter a date that is equal to or earlier than the current date.

PTS04

Both Best Response and Nonresponse Therapy Type are present/absent.

One and only one fields should be entered.

Derivations

Code

Field Name

Description

PTS1001

Therapy Type

Derive Therapy Type Code based on matching Therapy Type
Last updated by Blackburn, Katie (NIH/NCI) [C] on Apr 18, 2017