ID

35667

Description

Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Keywords

  1. 3/14/19 3/14/19 -
Copyright Holder

GSK group of companies

Uploaded on

March 14, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369

Treatment Completion Form

Administrative data
Description

Administrative data

Last Name
Description

Last Name

Data type

text

First Name
Description

First Name

Data type

text

Section
Description

Section

Data type

text

GOG #
Description

Inst.,Prot.,Seq.

Data type

integer

Treatment Completion
Description

Treatment Completion

Total number of courses of protocol therapy administered
Description

Total number of courses

Data type

integer

Reasons for discontinuing protocol treatment
Description

check only one

Data type

text

Specify Other
Description

Specify Other

Data type

text

Summarize plans for further anti-cancer therapy:
Description

plans for further therapy

Data type

text

Tumor Measurements
Description

Tumor Measurements

Data type

integer

Measurement units
  • cm
cm
Tumor Measurements
Description

Tumor Measurements

Location
Description

Location

Data type

integer

Method of Tumor Measurement
Description

Method

Data type

text

Date of assessment
Description

Date of assessment

Data type

date

Tumor measurements
Description

Tumor measurements

Data type

text

Measurement units
  • cm
cm
Best Tumor Response
Description

Best Tumor Response

Best Tumor Response
Description

Best Tumor Response

Data type

text

Date of Progression
Description

Date of Progression

Data type

date

Date of Best Response
Description

Date of Best Response

Data type

date

Follow-Up Form
Description

Follow-Up Form

Was the patient contacted for current scheduled follow-up
Description

Lost to follow-up

Data type

boolean

Vital Status
Description

Vital Status

Data type

text

Date patient last known alive or date of death
Description

Date of last contact

Data type

date

If dead, indicate contributing factor(s)
Description

Death reason

Data type

text

Disease Follow-Up Status
Description

Disease Follow-Up Status

Has the patient been assessed by a physician for progression/recurrence of this cancer since previous information submission?
Description

Disease Follow-Up Status

Data type

text

If Yes, date of assessment
Description

date of assessment

Data type

date

Has the patient been diagnosed with a progression/recurrence?
Description

disease progression/recurrence

Data type

boolean

Date of Progression/recurrence
Description

Progression/recurrence date

Data type

date

Determination method
Description

Determination method

Data type

integer

Site / Marker
Description

Site / Marker

Data type

text

If protocol therapy included radiation, is location of progression within the radiation port?
Description

location of progression

Data type

boolean

Notice of New Primary
Description

Notice of New Primary

Has a new malignant neoplasm or myelodysplastic syndrome (MDS) been diagnosed that was not previously reported?
Description

Notice of New Primary

Data type

boolean

Date diagnosed
Description

Date diagnosed

Data type

date

Long Term Adverse Events
Description

Long Term Adverse Events

Has patient experienced any adverse events that have not been previously reported or have persisted for 3 months or more?
Description

AE

Data type

boolean

Adverse Events details
Description

Adverse Events details

Sequence Number
Description

Sequence Number

Data type

integer

Description
Description

CTC Terminology

Data type

text

Grade
Description

Grade

Data type

text

Onset Date
Description

Onset Date

Data type

date

Is event related to protocol therapy?
Description

Causality

Data type

boolean

Additional Cancer Therapy
Description

Additional Cancer Therapy

Specify therapy
Description

Therapy type

Data type

text

Date therapy started
Description

Start Date

Data type

date

Specify reason
Description

reason

Data type

text

Comments
Description

Comments

Data type

text

Similar models

Treatment Completion Form

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Last Name
Item
Last Name
text
First Name
Item
First Name
text
Section
Item
Section
text
Gynecologic Oncology Group Number
Item
GOG #
integer
Item Group
Treatment Completion
Total number of courses
Item
Total number of courses of protocol therapy administered
integer
Item
Reasons for discontinuing protocol treatment
text
Code List
Reasons for discontinuing protocol treatment
CL Item
routine, completed planned study treatment (1)
CL Item
disease progression, as defined in the protocol (2)
CL Item
toxicity as permitted in protocol (3)
CL Item
patient refused further study treatment for reasons other than toxicity (4)
CL Item
death (5)
CL Item
patient off study treatment for other medical condition  (6)
CL Item
other (7)
Specify Other
Item
Specify Other
text
plans for further therapy
Item
Summarize plans for further anti-cancer therapy:
text
Tumor Measurements
Item
Tumor Measurements
integer
Item Group
Tumor Measurements
Item
Location
integer
Code List
Location
CL Item
Location #1 (1)
CL Item
Location #2 (2)
CL Item
Location #3 (3)
Method
Item
Method of Tumor Measurement
text
Date of assessment
Item
Date of assessment
date
Tumor measurements
Item
Tumor measurements
text
Item Group
Best Tumor Response
Item
Best Tumor Response
text
Code List
Best Tumor Response
CL Item
Complete Response (NED) (1)
CL Item
Partial (>50% decrease each lesion followed) (2)
CL Item
Stable (3)
CL Item
Increasing Disease (>50% increase in any tumor) (4)
CL Item
Not evaluated this course (5)
Date of Progression
Item
Date of Progression
date
Date of Best Response
Item
Date of Best Response
date
Item Group
Follow-Up Form
Lost to follow-up
Item
Was the patient contacted for current scheduled follow-up
boolean
Item
Vital Status
text
Code List
Vital Status
CL Item
Alive (1)
CL Item
Dead (2)
Date of last contact
Item
Date patient last known alive or date of death
date
Item
If dead, indicate contributing factor(s)
text
Code List
If dead, indicate contributing factor(s)
CL Item
cancer under study (1)
CL Item
protocol treatment (2)
CL Item
no information on cause (3)
CL Item
other, specify (4)
Item Group
Disease Follow-Up Status
Item
Has the patient been assessed by a physician for progression/recurrence of this cancer since previous information submission?
text
Code List
Has the patient been assessed by a physician for progression/recurrence of this cancer since previous information submission?
CL Item
Yes (1)
CL Item
no (2)
CL Item
Not applicable (3)
date of assessment
Item
If Yes, date of assessment
date
disease progression/recurrence
Item
Has the patient been diagnosed with a progression/recurrence?
boolean
Progression/recurrence date
Item
Date of Progression/recurrence
date
Item
Determination method
integer
Code List
Determination method
CL Item
histologically (1)
CL Item
radiologically (2)
CL Item
physically (3)
CL Item
marker (4)
Site / Marker
Item
Site / Marker
text
location of progression
Item
If protocol therapy included radiation, is location of progression within the radiation port?
boolean
Item Group
Notice of New Primary
Notice of New Primary
Item
Has a new malignant neoplasm or myelodysplastic syndrome (MDS) been diagnosed that was not previously reported?
boolean
Date diagnosed
Item
Date diagnosed
date
Item Group
Long Term Adverse Events
AE
Item
Has patient experienced any adverse events that have not been previously reported or have persisted for 3 months or more?
boolean
Item Group
Adverse Events details
Sequence Number
Item
Sequence Number
integer
Description
Item
Description
text
Grade
Item
Grade
text
Onset Date
Item
Onset Date
date
Causality
Item
Is event related to protocol therapy?
boolean
Item Group
Additional Cancer Therapy
Therapy type
Item
Specify therapy
text
Start Date
Item
Date therapy started
date
reason
Item
Specify reason
text
Comments
Item
Comments
text

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