Implementation of the group sequential methodology in a randomized trial in metastatic colorectal carcinoma Journal Article
| Authors: | Kemeny, N.; Reichman, B.; Geller, N.; Hollander, P. |
| Article Title: | Implementation of the group sequential methodology in a randomized trial in metastatic colorectal carcinoma |
| Abstract: | A prospective randomized trial using the group sequential statistical method with frequent planned interim analyses was initiated in patients with metastatic colorectal adenocarcinoma comparing methotrexate and 5 fluorouracil (MTX-FU) to methyl CCNU, vincristine, FU, and streptozotocin (MOF-Strep). As a requirement of the group sequential design, a p value of 0.0125 was necessary to stop the trial at the first analysis. The first analysis was done after 17 patients were entered in each study arm and revealed six partial responses to MOF-Strep (35%) and one partial response to MTX-FU (6%) (p=0.017). As a result, patient accrual continued. Problems encountered with the implementation of the group sequential methodology and the importance of statification for prognostic variables are discussed. |
| Keywords: | controlled study; major clinical study; fluorouracil; methotrexate; metastasis; vincristine; colorectal carcinoma; intravenous drug administration; oral drug administration; streptozocin; semustine; human; male; female |
| Journal Title: | American Journal of Clinical Oncology |
| Volume: | 11 |
| Issue: | 1 |
| ISSN: | 0277-3732 |
| Publisher: | Lippincott Williams & Wilkins |
| Date Published: | 1988-01-01 |
| Start Page: | 66 |
| End Page: | 72 |
| Language: | English |
| DOI: | 10.1097/00000421-198802000-00014 |
| PUBMED: | 2963534 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Export Date: 6 August 2020 -- Source: Scopus |
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