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Clinical Investigations: PleuraPhase III Intergroup Study of Talc Poudrage vs Talc Slurry Sclerosis for Malignant Pleural Effusion
Section snippets
Materials and Methods
This was an intergroup cooperative trial led by the CALGB and monitored semiannually by its Data and Safety Monitoring Board, with participation by the Radiation Therapy Oncology Group, the Eastern Cooperative Oncology Group (ECOG), and the North Central Cooperative Oncology Group, encompassing both private and teaching hospitals. Credentialing of participating surgeons was required. Institutional review board approval and written informed patient consent were obtained.
Patients were identified
Results
Between January 1995 and September 1999, 501 patients were randomized (TS, n = 250; TTI, n = 251). Nineteen patients were excluded: 13 were ineligible and 6 withdrew consent. Thus, 240 TS and 242 TTI patients remained for outcome analysis. Patient demographics (Table 1) and distribution of underlying malignancies (Table 2) were similar between study arms.
The criterion of > 90% lung re-expansion was met by 163 of 240 TS patients (68%) and 177 of 242 TTI patients (73%) [p = 0.231]. Among these,
Discussion
The current finding of no difference in the ability of talc, whether insufflated or placed as slurry, to prevent recurrence of MPE at 30 days is not surprising. An equivalence design was used because there was no a priori reason to expect that efficacy would differ between the study arms. Although there is considerable variability in reported “success” rates among published studies, a review15 of MPE studies published through 1994 reveals identical overall success rates of 91% for slurry (n =
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This work was supported by the National Cancer Institute (2 U01 CA65170)