Randomised trials in ovarian cancer: Trial design considerations

Annals of Oncology

Volumn 10, Issue SUPPL. 1, 1999, Pages

  Brady, M F ^a   Thigpen, J T ^b   Vermorken, J B ^c   Parmar, M K B ^d  

^a ROSWELL PARK CANCER INSTITUTE   (United States)

^b UNIVERSITY OF MISSISSIPPI SCHOOL OF MEDICINE   (United States)

^c ANTWERP UNIVERSITY HOSPITAL   (Belgium)

^d MEDICAL RESEARCH COUNCIL   (United Kingdom)

Author keywords

End point selection; Progression free survival; Response; Survival; Trial size

Indexed keywords

CANCER RISK; CANCER SURVIVAL; CLINICAL PRACTICE; CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; HUMAN; MEDICAL DECISION MAKING; OVARY CANCER; PATIENT CARE; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SAMPLING;

EID: 0032935927     PISSN: 09237534     EISSN: None     Source Type: Journal    
DOI: 10.1016/s0923-7534(20)31489-7     Document Type: Conference Paper

References (29)

1. Klienbaum DG, Kupper LL, Morgenstern H. Epidemiologic Research - Principles and Quantitative methods, Van Nostrand and Reinhold, New York 1982.
2. Sylvester R. Planning cancer clinical trials. Cancer Clinical Trials -Methods and Practice, eds: Buyse ME, Staquet, MJ and Sylvester, RJ, Oxford University Press, Oxford 1982.
3. Ellenberg JH. Selection bias in observational and experimental studies. Stat Med 1994; 13: 557-67.
4. Staquet M, Dalesio O. Designs for phase III trials. Cancer Clinical Trials - Methods and Practice, Ed: Buyse ME, Staquet MJ and Sylvester RJ, Oxford University Press, Oxford 1984.
5. Fleming TR, DeMets DL. Surrogate endpoints in clinical trials: Are we being misled? Ann Int Med 1994; 125: 605-13.
6. Creasman WT. Second look laparotomy in ovarian cancer. Gynecol Oncol 1994; S122-7.
7. McGuire WP, Hoskins WJ, Brady MF et al. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. New Engl J Med 1996; 334 (1): 1-6.
8. Thiesse P, Olivier L, Di Stefano-Louineau D et al. Response rate accuracy in oncology trials: reasons for interobserver variability. J Clin Oncol 1997; 15 (12): 3507-14.
9. Muggia FM, Braly PS, Brady MF et al. A Phase III trial of cisplatin or paclitaxel versus their combination in suboptimal stage III and IV epithelial ovarian cancer: Gynecologic Oncology Group Study 132. Proc Am Soc Clin Oncol 1997; 16: 1257 (Abstr).
10. Wiltshaw E. Chemotherapy for ovarian cancer: Is there a best buy? Gynecol Oncol 1992; 45: 113-4.
11. Freiman J, Chalmers TC, Smith H, Keubler RR. The importance of beta, the type II error and sample size in the design and interpretation of the randomised control trial. New Engl J Med 1978; 299: 690-4.
12. Wittes RE, Freidman MA, Simon R. Some thoughts on the future of clinical trials in cancer. Cancer Treat Rep 1978; 70 (2): 241-50.
13. Machin D, Stenning SP, Parmar MKB et al. Thirty years of medical research council randomised trials in solid tumours. Clin Oncol 1997; 9: 100-14.
14. Advanced Ovarian Cancer Trialists Group, Chemotherapy in advanced ovarian cancer: an overview of randomised clinical trials. BMJ 1991; 303: 884-93.
15. Tropé C, Kaern J, Vergote I. Adjuvant therapy for early stage epithelial ovarian cancer, Ovarian Cancer - Controversies in Management, eds: Gershenson, DM and McGuire, WP, Churchill Livingston Inc., New York 1998.
16. Stuart G, Bertelsen K, Mangioni C et al. Updated analysis show a highly significant improved overall survival for cisplatin-paclitaxel as first line treatment of advanced ovarian cancer: Mature results of the EORTC-GCCG, NOCOVA, NCIC CTG and Scottish intergroup trial. Proc Am Soc Clin Oncol 1998; 17: 1394 (Abstr).
17. Markman M, Bundy B, Benda J et al. Randomised phase III study of intravenous cisplatin/paclitaxel versus moderately high dose carboplatin followed by IV paclitaxel and intraperitoneal cisplatin in optimal residual ovarian cancer: an intergroup trial (GOG, SWOG, E-COG). Proc Am So Clin Oncol 1998; 17; 1392 (Abstr).
18. Gregory WM, Bolland K, Whitehead J, Souhami, RL. Cautionary tales of survival analysis: conflicting analyses from a clinical trial in breast cancer. Br J Cancer 1997; 76(4): 551-8.
19. Rubinstein LV, Gail MH, Santner TJ. Planning the duration of comparative clinical trial with loss to follow-up and a period of continued observation. J Chron Dis 1981; 34: 469-79.
20. Yusuf S, Collins R, Peto R. Why do we need some large and simple randomised trials? Stat Med 1981; 3: 409-20.
21. Blumenson LE. Loss of power from an optimistic alternative hypothesis. Stat Med 1988; 7: 457-66.
22. Simon R. Patient subsets and variation in therapeutic efficacy. Br J Clin Pharmacol 1982; 14: 473-82.
23. Fayers PM, Machin D. Sample size: how man patients are necessary? Br J Cancer 1995; 72: 1-9.
24. Liu PY, Dahlberg, S. Design and analysis of multiarm clinical trials with survival endpoints. Controlled Clin Trials 1994; 16: 119-30.
25. Bristol DR. Sample sizes for constructing confidence intervals and testing hypotheses. Stat Med 1989; 8: 803-11.
26. Parmar MB, Ungerleider RS, Simon, R. Assessing whether to perform a confirmatory randomised clinical trial. J Nat Cancer Inst 1996; 88 (2): 1645-51.
27. Geller NL, Pocock SJ. Interim analyses in randomised clinical trials: ramifications and guidelines for practitioners. Biometrics, 1987; 43: 213-23.
28. Fayers PM, Ashby D, Parmar MKB. Tutorial in biostatistics: Bayesian data monitoring in clinical trials. Stat Med 1997; 16: 1413-30.
29. Schoenfeld D. Sample size formula for the proportional hazards regression model. Biometrics 1983; 39: 499-503.