Follow-up Form – Page 1

Report
STAMPEDE
Systemic Therapy in Advancing or Metastatic Prostate
Cancer: Evaluation of Drug Efficacy
Arm J CRF Training
Katie Ward
STAMPEDE Data Manager
May 2014
Overview
• Arm J CRF changes - indicated in purple
• General CRF training - indicated in black
• Reporting progression
• Reporting SAEs
Randomisation Form – Page 1
Inclusion and
Exclusion Criteria
New exclusion
criteria added
Ensure that the
patient’s eligibility is
checked before
randomisation, and
that all boxes are
unambiguously
ticked to confirm
this.
Randomisation Form – Page 2
The PSA value provided
should be the most
recent test result prior
to the start of hormone
therapy.
Q15 should be
answered as 0=None
if the patient is not
relapsing (broad
disease category 4).
Randomisation Form – Page 3
Any contraindications
to radiotherapy should
be discussed with the
trial team prior to
randomisation.
Intended start date of
trial treatment should
be within 4 weeks of
randomisation.
Q27c is not asked on
the randomisation
server but should still
be completed for all
metastatic patients
and all patients
planned to receive RT
to the prostate as
part of standard
treatment.
Baseline Form – Page 1
Please remember to
indicate whether an
AST or ALT
measurement is
provided here by
crossing through as
appropriate.
If endocrinology
prior to hormone
therapy is not
available, please
answer 0=No to Q23
and go to Q26.
If endocrinology is
available prior to HT,
please answer 1=Yes
to Q23 and answer
Q24 and 25.
All blood tests should
be taken within 8
weeks prior to
randomisation.
These questions relate to
initial disease presentation,
not the current disease
status.
Relapsing patients: provide
earliest date of diagnosis.
Baseline Form – Page 2
Please remember to
provide the type and dose
if Q32 is answered 1 or 4,
and if Q35 is answered is
answered 1=Yes.
Please provide as much
information as possible
relating to concomitant
medications.
If full dates are not known,
try to provide partial dates.
If any information is
definitely not available,
please write ‘Not Known’ or
‘NK’ accordingly.
Cardiovascular Form
This refers to the
patient’s current
smoking status, not
whether they have
previously smoked.
If any of these
questions (Q14-Q18)
are answered 2=Yes
and patient is ineligible,
the patient should not
be randomised.
Bone Density Risk Factor Questionnaire
This CRF should be
completed for all patients
prior to randomisation, and
does not relate to the bone
mineral density sub-study.
Arm J: Safety analysis
• First safety review – first 50 patients allocated to Arm A and first 50
patients allocated to Arm J on trial for ~6wks
• Second safety review – first 50 patients allocated to Arm A and first
50 patients allocated to Arm J on trial for ~6mths
• Additional safety reviews at the request of the IDMC
• Please submit all follow-up forms in a timely manner. Any
outstanding CRFs will be chased regularly in view of the safety
analyses.
Follow-up schedule
6 weekly
12 weekly
6 monthly
Annually
Randomisation to 24 weeks
24 weeks to 2 years
2 years to 5 years
Thereafter
• Follow-up dates will be sent to you on a treatment and follow-up
schedule each time you randomise a patient.
• The expected follow-up dates on the treatment schedule are
calculated from the date of randomisation.
• If a patient fails to attend a follow-up visit, please submit a
follow-up form marked with the appropriate week number and a
note to say ‘missed visit’.
Follow-up Form – Page 1
The week number
should always
correspond to the
follow-up schedule
(i.e. week 6, 12, 18).
If Q9 or Q12 are
answered 1=Yes, an
Abiraterone and
Enzalutamide Treatment
Form should be
completed.
Q9 and 12 should be
answered 1=Yes for all
Arm G and Arm J
patients at week 6 and
the start of abiraterone
and/or enzalutamide
treatment should be
reported on the
Abiraterone and
Enzalutamide Treatment
Form.
If Q5, 6 or 7 are
answered 1=Yes, a
progression form
should also be
completed.
If Q8 is answered
1=Yes, a Hormone
Therapy Treatment
Form should be
completed.
Compliance: report
number of tablets
missed rather than
days.
The addition of Q11
now requires the daily
dose of prednisolone to
be reported for all Arm
G and J patients.
Hormone Therapy Form
This CRF only needs to be
completed when there has
been a change to hormone
therapy since the last
reported assessment.
At week 6, Q3 does not
need to be answered
‘started’ if treatment
with LHRH was reported
at randomisation and
has not changed.
Please remember
to answer Q8 and
Q13 as 0=No if
treatment has not
changed.
Abiraterone and Enzalutamide Treatment Form
This CRF should be
completed alongside the
follow-up form for all
patients on Arms G and J
at week 6.
The week number and
date of assessment
should correspond to
the relevant follow-up
form.
Thereafter, it should only
be completed alongside
the follow-up form when
there is a change in
abiraterone or
enzaluatmide treatment.
For Arm J patients, if
treatment to only one
of the trial drugs has
changed, please
answer ‘0=No,
treatment continues
as before’ for the
other trial drug.
Follow-up Form – Page 2
Waist
measurements
should be reported
on the baseline
form and at annual
follow-ups.
0
1
0
Equally, if the
Yes/No question
for a group has
been answered
as 0=No, grades
should not be
entered for any
of the listed
toxicities. In this
instance, any
grade above 0
will result in a
data query.
0
0
0
0
0
0
0
0
3
2
Nocturia
If the Yes/No
question for a
group has been
answered as
1=Yes, please
ensure a grade
is reported for
all toxicities
listed. If the
toxicity is not
present, please
enter ‘0’. Boxes
left blank will
result in a data
query.
Please also
remember to
describe any
‘other’ toxicities.
Follow-up Form – Page 3
New toxicities
added
Follow-up Form – Page 4
RTOG late side effects to be completed for all patients having radiotherapy –
“2=not applicable” added as option.
Follow-up Form (Post-Progression)
This CRF should be
completed at each
follow-up visit following
progression.
Arm G and Arm J
patients: this CRF
should only be
completed when all
types of progression
have been reported or
a second-line treatment
has been prescribed.
Until this time, the
regular follow-up form
(including toxicities)
should be used.
PSA test results
should be reported
for all patients
post-progression
Progression and Additional Treatment Form – Page 1
‘2=First instance
already reported’ is
now an option for
biochemical failure and
all other types of
progression (please see
key in table).
This CRF should be
completed when a
patient’s disease
progression is confirmed.
Each type of progression
only needs to be reported
once, the first time it
occurs.
Questions remain the
same; layout has
changed to hopefully
capture data more
easily.
Questions have been
added to gain further
data on skeletal-related
events. For example,
has the SRE been
confirmed as disease
progression?
Reporting Biochemical Failure
• Confirmatory PSA test between 1 week and 3 months later:
• If value is ≥PSA progression value then report biochemical
progression
• If the clinician adds anti-androgens to control a rising PSA:
• Report progression
• PSA progression emails are sent to sites approx. 3-monthly
• Baseline and FU forms up to week 24 needed
• Alternatively contact the trial team for help
Progression and Additional Treatment Form – Page 2
Please ensure an
answer is given to
all listed
treatments. If a
treatment was not
given, enter a ‘0’
Any blank fields will
result in a data
query.
If the finish date is not
known because the
treatment is ongoing,
please ensure that the
question ‘ongoing’ is
answered as 1=Yes.
LHRH removed
New treatments for
progression added.
These include:
enzalutamide (not
trial treatment),
prednisolone,
dexamethasone,
radium-223.
Please note that †1 relates
to question 24, †2 to 25
and †3 to 26.
Additional Treatment Update Form
This CRF should be
used to report new
information about a
patient’s treatment for
progression – the type
of progression itself
must already have
been reported on a
Progression and
Additional Treatment
Form.
SAE Form
The main event should
be noted along with
the date of onset (e.g.
when the patient was
admitted to hospital)
and the current
status.
CRFs can up updated
with resolution details.
Causality and
expectedness
should both be
completed to
assess if an
event is a SAE,
SAR or SUSAR.
If a new event occurs
whilst in hospital and
it is not an associated
symptom, it should be
reported on a new
CRF.
All trial medication
details (including
information for HT,
whether just on Arm A
or not) should be
provided.
Clinician should sign and date both pages of the SAE form
Notifications and Responsibilities
• Investigators must notify the MRC CTU of
all SAEs occurring from the time of randomisation
up until 30 days after the last protocol treatment administration
• SAEs occurring in patients randomised to Arm A
must be reported until 30 days after last injection or progression
(whichever is sooner)
• SARs and SUSARs must be notified to the MRC CTU
(i.e. no matter when they occur after randomisation)
• SAEs must be notified using the appropriate SAE form by fax
 +44 (0) 2076704818
Exceptions
• Disease progression
• Death as result of disease progression
• Elective hospitalisation and surgery for treatment of locally advanced
or metastatic cancer or its complications
• Elective hospitalisation for pre-existing conditions that have not
been exacerbated by trial treatment
• Elective hospitalisation for pre-existing conditions to simplify
treatment or procedures
Radiotherapy Detail Form
This CRF is expected
for all patients,
irrespective of arm
allocation.
If radiotherapy wasn’t
planned and wasn’t
given, answer Q1 as
0=No and the form is
complete.
If radiotherapy wasn’t
given but was planned
at randomisation or
the patient is on Arm
H, please complete
Q1a, specifying why
radiotherapy was not
given.
For patients who
receive RT, this
CRF should be
completed when
the patient’s
primary course of
RT is completed.
For patients who
do not receive
primary RT, it
should be
completed 10
months after
randomisation to
confirm RT was
not given.
Please check the
answer to Q8
carefully. Usually
on STAMPEDE
CRFs 0=No and
1=Yes, but here
the answers are
reversed.
Radiotherapy Acute Toxicity Form
This CRF should be
completed for all patients
who receive primary RT.
Arm H patients: it
should be completed 10
weeks after the start of
RT.
All other patients: it
should be completed 18
weeks after the start of
RT.
Toxicities can be
completed on alternate
weeks, as long as all
missing weeks are
completed
retrospectively.
Toxicities can also be
recorded via telephone
follow-up with the
patient.
End of Treatment Form
This CRF should be
completed
whenever a patient
permanently stops
trial treatment,
other than
radiotherapy.
If a patient never
started trial
treatment, please
submit an end of
treatment form
detailing this on
the CRF.
Please record the
status of each
treatment and
check that the
information
about treatment
end has been
entered into the
correct column.
Enzalutamide
column added.
Death Form
This CRF should be
completed as soon as
possible after a
patient has died.
If there were no other
contributing causes of
death, enter ‘00’ for
questions 3, 4 or 5.
Please ensure an
anonymised copy of
the post-mortem is
submitted to the CTU.
Co-enrolment Form
This CRF should be
completed when a
patient enrols in
another clinical trial
after randomisation.
Quality of Life Form
• If the patient has consented to participate in the Quality of Life
study, a copy of the form should be completed at baseline and
alongside every follow-up visit.
• Quality of Life forms should be completed for Arm G and Arm J
patients until all types of progression have been reported.
• Quality of Life forms do not need to be completed postprogression for patients on all other arms.
• Please email the trial team for a copy of the Quality of Life Form.
End of Trial Participation Form
This CRF should not be
used if the patient is
stopping treatment
early. In this instance,
please use an End of
Treatment Form.
Following discussion
with the patient and
trial team, this CRF
should only be used if
the patient wishes to
end their trial
participation.
General CRF Completion Tips
• Please ensure the most up-to-date version of the CRF is being
used.
• CRFs should always be signed and dated on the date of
completion by a member of staff listed on the STAMPEDE
delegation log.
• If a mistake if made, please cross through the original answer
with a single line, and initial and date the correction.
• Please report values in the units provided on the CRFs.
• If an answer is not known, please write ‘not known’ or ‘NK’ next to
the question. If a test was not carried out, please write ‘not done’
or ‘ND’ next to the question.
Contact us
Web: www.stampedetrial.org
MRC
Francesca Schiavone
Clinical Trial Manager
T: +44 (0) 207 670 4632
E: [email protected]
Alanna Brown
Clinical Trial Manager
T: +44 (0) 207 670 4882
E: [email protected]
Dominic Hague, Katie Ward, Peter Vaughan
STAMPEDE Data Managers
T: +44 (0) 207 670 4809 / 4794 / 4947
E: [email protected]

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