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Symptom Benefit ANZGOG-0701. Does Palliative Chemotherapy Improve Symptom Control in Platinum Resistant Ovarian Cancer. , START UP MEETING FOR STAGE 2. Response Rates in Phase 3 Trials. Patients with good PS entered into clinical trials- 2 nd Line Therapy. Symptom Benefit Study.

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Symptom benefit anzgog 0701 l.jpg

Symptom BenefitANZGOG-0701

Does Palliative Chemotherapy

Improve Symptom Control in Platinum Resistant Ovarian Cancer

,START UP MEETING FOR STAGE 2


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Response Rates in Phase 3 Trials

Patients with good PS entered into clinical trials- 2nd Line Therapy


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Symptom Benefit Study

Expectation is that Symptom Benefit > Response Rate

( otherwise why would we treat so many patients )

  • How to best measure the impact of chemotherapy on symptom improvement ?

  • Can we use Symptom Benefit Measures as an alternative outcome measure

  • Can we identify patients most likely to benefit from palliative chemotherapy?


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Stage 1-Primary Aim

  • The symptoms and aspects of HRQL that are rated as most severe, troublesome and important by patients.

  • The optimal items and questionnaire/s for measuring these improvements.


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Study Schema

  • Target Population

  • >18yrs

  • platinum resistant/ refractory epithelial ovarian cancer

  • /> 3 lines of therapy

  • ECOG 0-3

  • Able to commence treatment within 2wks of registration

  • Sufficient English to complete QoL forms

  • independently

  • Stage1

  • 100 patients

  • Complete 7 QoL

  • forms

  • 20 subjects will

  • participate in

  • additional QoL

  • telephone interview

Data Collection

4 Treatment cycles

or

Disease progression

REGISTER


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Stage 1 QoL Questionnaires

  • Symptom Representation Questionnaire

  • FACT-O (includes FOSI)

  • EORTC QLQ-C30

  • EORTC QLQ-OV28

  • Patient Data Form

  • Expected and Perceived Benefit Scale

  • HAD Scale (Baseline & End of Treatment)

  • Herth Hope Index (Baseline & End of Treatment only)


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Results

  • Majority Platinum Resistant

  • Compliance 96%

    All questionnaires were completed to a very high compliance rate with few or no missing data





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Improvement in quality of life AE’s at baseline(Prior to Cycle 3 N=72)

Is your symptom improvement enough to affect your overall quality of life?


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Stage 1-outcome AE’s at baseline

Results have led to development of

MOST(Measure of Ovarian cancer Symptoms and Treatment concerns)

Modification of Patient Data Form

COVERS ALL SYMPTOMS AND ASPECTS OF QOL IDENTIFIED IN STAGE 1


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MOST AE’s at baselineMeasure of Ovarian cancer Symptoms and Treatment concerns

Comprises of 35 individual items on a discrete scale of 0-10, where major symptomatic distress is represented by 10.

The first 15 items refer to disease symptoms

Items 16 and 17 refer to physical and emotional well-being

Item 18 is a question referring to overall well-being

Items 19-35 deals with side effects and other concerns

The study will examine the extent of clinical improvement by examining changes in these items from baseline at each time point- to determine MCID


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  • Target Population AE’s at baseline

  • Informed consent

  • ≥18yrs

  • Platinum Resistant/Refractory

  • ECOG 0-3

  • Life expectancy > 3 months

  • Able to commence treatment within 2wks of registration

  • Able to complete questionnaires independently

R

E

G

I

S

T

E

R

  • Data Collection

  • Baseline

  • Each treatment cycle

  • One month post completion of treatment or until disease progression

Schema – Stage 2


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Stage 2 AE’s at baseline

Primary Objective To determine:

The criteria for defining a clinically significant subjective improvement and the optimal instrument/s to measure benefit

Secondary Objectives

  • The proportion of women benefiting from palliative chemotherapy

  • The time to symptom deterioration

  • The proportion of women who receive treatment because they are (a) symptomatic, (b) have rising tumor markers alone, or (c) have imaging evidence of disease progression

  • The percentage of patients who complete 4 or more cycles of treatment

  • The most common, most severe and most noticed symptoms as perceived by patients.

  • Develop a prognostic index


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Stage 2 AE’s at baseline

  • MOST

  • FACT-O

  • EORTC QLQ C30

  • EORTC OV28

  • Expected and Perceived Benefits

    These forms will be completed at Baseline and after each cycle until chemotherapy ceases.


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Prognostic Factors AE’s at baseline


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Recruitment AE’s at baseline

The recruitment target is 600 evaluable patients

(~780 enrolled patients)

The estimated recruitment period is until December 2011

Currently there are 20 sites activated and 101 patients recruited with a further 40+ sites to open

International participation

Canada (additional sites) To be confirmed

United Kingdom Japan

Ireland Spain

Germany Scandinavia

Italy France

USA- selected sites


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Central Study Contacts AE’s at baseline

Study Chair: Professor Michael Friedlander ANZGOG

Coordinating Centre: Symptom Benefit

NHMRC Clinical Trials Centre

Locked Bag 77

CAMPERDOWN NSW 1450

AUSTRALIA

Study team: symptombenefit@ctc.usyd.edu.au

Central Coordinator: Kim Gillies +61 2 9562 5032 kim.gillies@ctc.usyd.edu.au

Data Manager: Lisa Martyn +61 2 9562 5394 lisa.martyn@ctc.usyd.edu.au

Program Manager: Julie Martyn +61 2 9562 5092 julie.martyn@ctc.usyd.edu.au