The Statistical Center (SC) of the Southeastern Cancer Study Group (SECSG) will provide the statistical analysis and design of SECSG protocol studies. Before a study is activated, the SC will a) specify the number of evaluable cases necessary to achieve statistical significance, and b) estimate the length of time necessary to complete the study based on randomization or stratification criteria in the protocol. The SC personnel also include in the protocol the schedule of reporting procedures and copies of all necessary forms. When necessary the SC will implement deterministic randomization techniques for patient assignment. The SC will collect relevant initial data for all patients entered on SECSG studies. When a patient completes a study, the SC evaluates his course of treatment and decides, in consultation with Project Chairmen, the evaluability and response to treatment of each patient in accordance with SECSG criteria. All data relevant to a case is to be stored and may be retrieved for analysis. All interim and final analysis of protocols are presented at Group meetings. Such analyses will include rate and duration of response or DFI, survival or response. At such presentations, the SECSG Statisticians discuss the feasibility of continuing or closing a particular study; also, progress reports are prepared for each active protocol. When a study is complete, the statistician assigned to the protocol shall assist the Project Chairmen in preparing a report of the results of the study for publication. The SC will monitor all protocols for unanticipated toxicity or response and, when necessary, report its findings to the Project Chairmen. Every month, the SC compiles a member-institution report listing the number of cases entered, completed and evaluable, and paperwork status, and notifies the SECSG Executive Committee of these findings when the committee meets.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10CA024456-08
Application #
3556716
Study Section
Cancer Clinical Investigation Review Committee (CCI)
Project Start
1977-12-01
Project End
1988-07-31
Budget Start
1985-08-01
Budget End
1988-07-31
Support Year
8
Fiscal Year
1985
Total Cost
Indirect Cost
Name
University of Alabama Birmingham
Department
Type
Schools of Medicine
DUNS #
004514360
City
Birmingham
State
AL
Country
United States
Zip Code
35294
Volger, W R; Weiner, R S; Moore, J O et al. (1995) Long-term follow-up of a randomized post-induction therapy trial in acute myelogenous leukemia (a Southeastern Cancer Study Group trial). Leukemia 9:1456-60
Omura, G A; Bass, D (1994) Prognostic factor analysis of central nervous system relapse in adult acute lymphoblastic leukemia. A Southeastern Cancer Study Group report. Am J Clin Oncol 17:93-6
Omura, G A; Vogler, W R; Martelo, O et al. (1994) Late intensification therapy in adult acute lymphoid leukemia: long-term follow-up of the Southeastern Cancer Study Group experience. Leuk Lymphoma 15:71-8
Vogler, W R; McCarley, D L; Stagg, M et al. (1994) A phase III trial of high-dose cytosine arabinoside with or without etoposide in relapsed and refractory acute myelogenous leukemia. A Southeastern Cancer Study Group trial. Leukemia 8:1847-53
Martelo, O J; Omura, G A; Gordon, D S et al. (1992) Late intensification therapy in adult acute lymphoid leukemia. The Southeastern Cancer Study Group Experience. Am J Clin Oncol 15:61-8
Vogler, W R; Velez-Garcia, E; Weiner, R S et al. (1992) A phase III trial comparing idarubicin and daunorubicin in combination with cytarabine in acute myelogenous leukemia: a Southeastern Cancer Study Group Study. J Clin Oncol 10:1103-11
Nichols, C R; Williams, S D; Loehrer, P J et al. (1991) Randomized study of cisplatin dose intensity in poor-risk germ cell tumors: a Southeastern Cancer Study Group and Southwest Oncology Group protocol. J Clin Oncol 9:1163-72
Kramer, B S; Birch, R; Greco, A et al. (1988) Randomized phase II evaluation of iproplatin (CHIP) and carboplatin (CBDCA) in lung cancer. A Southeastern Cancer Study Group trial. Am J Clin Oncol 11:643-5
Keller, J W; Omura, G A; Gams, R A et al. (1987) Weekly mitoxantrone therapy of Hodgkin's disease, non-Hodgkin's lymphoma, and chronic lymphocytic leukemia. A Southeastern Cancer Study Group Trial. Am J Clin Oncol 10:194-5
Williams, S D; Birch, R; Einhorn, L H et al. (1987) Treatment of disseminated germ-cell tumors with cisplatin, bleomycin, and either vinblastine or etoposide. N Engl J Med 316:1435-40

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