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SIR and the Management of Cancer Trial Data. Kate Motohashi Gray Cancer Institute, Northwood, UK. Introduction. BCON Trial Coordinator/ Data Manager since May 2001 Biology background with no experience of databases!. Topics of Discussion. Background to the trial The database

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sir and the management of cancer trial data

SIR and the Management of Cancer Trial Data

Kate Motohashi

Gray Cancer Institute, Northwood, UK

introduction
Introduction
  • BCON Trial Coordinator/ Data Manager since May 2001
  • Biology background with no experience of databases!
topics of discussion
Topics of Discussion
  • Background to the trial
  • The database
  • Retrieval of data
  • Restructuring of the database
  • Some questions
slide4

A MULTICENTRE RANDOMISED PHASE III TRIAL OF RADIOTHERAPY WITH CARBOGEN AND NICOTINAMIDE IN THE TREATMENT OF LOCALLY ADVANCED BLADDER CANCERTRIALPI: Prof Peter HoskinTRIAL STATISTICIAN Prof Søren BentzenFunded by the Cancer Research UK

slide5
BCON
  • Bladder cancer 
  • Carbon dioxide 2%
  • Oxygen 98%
  • Nicotinamide
bladder cancer
Bladder Cancer
  • ~ 4% of all cancers in UK
  • UK incidence 2000: 11 080 (with just over two-thirds men)
  • Peak incidence in 7th decade
  • History of smoking/ exposure to chemicals
treatment of bladder cancer
Treatment of bladder cancer
  • Surgery

1.Transurethral resection (TUR)

2.Total cystectomy

  • Chemotherapy
  • Radiotherapy
overall 5 year survival after rt
Overall 5 year survival after RT
  • T2, T3 &T4 (muscle invasive): 5-40%
reasons for rt failure
Reasons for RT failure
  • Intrinsic cell radio-resistance
  • Tumour repopulation during RT
  • Resistant cells due to HYPOXIA

HYPOXIA: the reduction of the O2

supply to tissue below physiological levels

- O2 is crucial for RT success

aim of bcon trial
Aim of BCON Trial
  • To address the problem of hypoxia by addition of the hypoxia modifying agents, carbogen and nicotinamide
slide11
CARBOGEN: 02 (98%) and C02 (2%)

Oxygenation of the tumour is increased when cabogen is breathed

  • NICOTINAMIDE: amide of vitamin B3

Improves perfusion by reducing closure of blood vessels

phase ii study at mvh
Phase II study at MVH
  • 30 patients received carbogen alone
  • 32 patients received CON

When compared to historical data significant gains were observed in

  • Local tumour control
  • Disease-free survival
  • Overall survival
bcon trial
BCON Trial
  • Control arm

RT alone

  • Experimental arm

RT plus CON

endpoints of bcon trial
Endpoints of BCON Trial
  • Tumour response at 6 months
  • Local-failure free survival*
  • Overall disease specific survival
  • Treatment related morbidity*
  • Quality of Life*

* Requiring ability to store records at different time-points

target accrual to detect 15 improvement in local control
Target Accrual (to detect 15% improvement in local control)
  • 330 patients over 4 years
  • Recruitment started Nov 2000
why sir
Why SIR?
  • Good at handling clinical data where patients have multiple visits
  • Compatibility with SPSS

SIR 2000 or SIR 2002?

Old Forms

  • Developed with colour, ‘if’ clauses, width definitions etc
  • Allow double data entry
design of database
Design of database
  • Case orientated – patient number
  • Schema modelled on Case Report

Forms

  • Multiple records for morbidity data,

cystoscopy results and QoL

retrieval of data
Retrieval of data
  • Accrual status
  • Dumping to SPSS
  • Follow-up status
  • CRF compliance
  • Reimbursement status
  • Data verification/ error-checking
  • Compliance to Nicotinamide
slide24

Old cystoscopy gradings

  • 0 no tumour
  • 1 > 50% reduction
  • 2 < 50% reduction
  • 3 progression
  • 4 recurrence after complete remission
  • 5 new superficial cancer
new cystoscopy gradings
New cystoscopy gradings
  • 0 no tumour
  • 1 superficial
  • 2 muscle invasive
1 missing values
1. Missing Values
  • Up to three values can be specified which are missing values for the variable. Missing values are excluded from statistical procedures and functions.

BCON Database Missing Values

  • BLANK = not available (ever)
  • ‘9’/ ‘99’/ ‘999’ etc = not available (yet)
slide28
RETRIEVAL

.PROCESS CASES ALL

. PROCESS REC NEWCYST

. GET VARS TUMSTATE

. IFTHEN (EXISTS (TUMSTATE) EQ 0) WRITE PATNO

. ENDIF

. END PROCESS REC

.END PROCESS CASE

END RETRIEVAL

This retrieves field with missing value but doesn’t distinguish between different categories of missing values

2 wild card searches
2. Wild card searches
  • Using search mode in forms and % for unknown characters
  • E.g. ‘F%W%’
  • Can it be done with PQL?
3 editing log
3. Editing Log
  • Journalling – logs changes to the database
  • Is it possible to create a log where person editing data is prompted to give a reason for the change?
acknowledgements
Acknowledgements
  • Prof Søren Bentzen
  • Prof Peter Hoskin
  • Dr Francesca Buffa
  • Trial centre contacts
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