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Phase II Randomized Multi-center Trial of Total Neoadjuvant Therapy With and Without CD40 Agonist, APX005M, for Locally Advanced Rectal Adenocarcinoma

2019-10-24 12:49:55 | BioPortfolio

Summary

Determine the complete pathologic complete response (pCR) rate in patients with locally advanced rectal adenocarcinoma.

Description

A phase II randomized trial 3:2 with continuous safety assessment for at least 6 patients. Interim analysis after 30 patients for early stopping criteria for futility or efficacy. The null hypothesis is that pCR is 16% and to reject the null hypothesis we aim to show a 48% pCR rate using a 5% one sided type 1 error boundary with 80% power. At interim analysis if the test statistic is less than or equal to 2.488 then the trial will be stopped with rejection of the null hypothesis. If the test statistic is less than or equal to 0.442 then we accept the null hypothesis and stop the trial early.

Study Design

Conditions

Locally Advanced Rectal Adenocarcinoma

Intervention

Radiation Therapy 5Gy x 5 days

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas
Texas
United States
75390

Status

Not yet recruiting

Source

University of Texas Southwestern Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-24T12:49:55-0400

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