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Determine the complete pathologic complete response (pCR) rate in patients with locally advanced rectal adenocarcinoma.
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.
Locally Advanced Rectal Adenocarcinoma
Radiation Therapy 5Gy x 5 days
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Not yet recruiting
University of Texas Southwestern Medical Center
Published on BioPortfolio: 2019-10-24T12:49:55-0400
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Drugs used to protect against ionizing radiation. They are usually of interest for use in radiation therapy but have been considered for other, e.g. military, purposes.
A therapeutic approach, involving chemotherapy, radiation therapy, or surgery, after initial regimens have failed to lead to improvement in a patient's condition. Salvage therapy is most often used for neoplastic diseases.
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Polymerase Chain Reaction (PCR)
PCR (Polymerase Chain Reaction) uses the ability of DNA polymerase (enzymes that create DNA molecules by assembling nucleotides, the building blocks of DNA. These enzymes are essential to DNA replication and usually work in pairs to create two ident...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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