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Evidence-based medicine in the treatment of ... - Alfredo Garofalo

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Figure 2: Study design <strong>of</strong> <strong>the</strong> PSOG-USMCI cl<strong>in</strong>ical trial.<br />

Limited<br />

Peritoneal Surface<br />

Malignancy <strong>of</strong><br />

Colonic<br />

Orig<strong>in</strong><br />

with<br />

No prior<br />

Cytoreduction<br />

S<br />

T<br />

R<br />

A<br />

T<br />

I<br />

F<br />

Y<br />

Sync<br />

Vs<br />

Met<br />

Measurable<br />

Vs<br />

Not meas.<br />

R<br />

A<br />

N<br />

D<br />

O<br />

M<br />

I<br />

Z<br />

E<br />

Best Systemic<br />

Therapy<br />

N=155<br />

Cytoreduction<br />

+ HIPEC (MMC)<br />

+ Best Systemic<br />

Rx<br />

N=155<br />

Primary Outcome<br />

1.Overall Survival<br />

Cross<br />

Over Secondary Outcomes<br />

At 1. PFS<br />

Progression<br />

2. Toxicity burden<br />

3. QOL appraisal<br />

4. CTC dur<strong>in</strong>g Rx

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