Clinical trials in gynecological cancer

doi:10.1111/j.1525-1438.2007.00667.x

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Wiley InterScience

International Journal of Gynecological Cancer

Volume 17 Issue 3, Pages 547 - 556

Published Online: 25 Jan 2007

The official journal of the European Society of Gynecological Oncology

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Clinical trials in gynecological cancer

E.L. TRIMBLE*, J. DAVIS*, P. DISAIA*, K. FUJIWARA*, D. GAFFNEY*, G. KRISTENSEN*, J. LEDERMANN*, J. PFISTERER*, M. QUINN*, N. REED*, M. SCHOENFELDT* & J.T. THIGPEN* (GYNECOLOGIC CANCER INTERGROUP)

*National Cancer Institute—Cancer Therapy Evaluation Program; North Glasgow University Hospitals NHS Trust; University of California Medical Center at Irvine; Saitama Medical University, Huntsman Cancer Hospital—University of Utah; Norwegian Radium Hospital; Cancer Research UK and UCL Cancer Trials Centre; Universitätsklinikum Schleswig-Holstein Campus Kiel; University of Melbourne; Beatson Oncology Centre; The EMMES Corporation; and University of Mississippi School of Medicine

Correspondence to Edward L. Trimble, MD, MPH, Lancer Therapy Evaluation Program, National Cancer Institute, Room 741, MSC 7436, 6130 Executive Blvd., Bethesda, MD 20892. Email: trimblet@ctep.nci.nih.gov

KEYWORDS

gynecologic cancer • ovarian cancer • cervical cancer • endometrial cancer • clinical trials • GCIG

Trimble EL, Davis J, DiSaia P, Fujiwara K, Gaffney D, Kristensen G, Ledermann J, Pfisterer J, Quinn M, Reed N, Schoenfeldt M, Thigpen JT (on behalf of the Gynecologic Cancer Intergroup). Clinical trials in gynecological cancer. Int J Gynecol Cancer 2007;17:547–556.

ABSTRACT

Abstract.

The Gynecologic Cancer Intergroup is comprised representatives from international gynecological cancer trials organizations, which collaborate in multicenter studies to answer the clinical challenges in gynecological cancer. This review article highlights the key clinical questions facing clinical trialists over the next decade, the information and infrastructure resources available for trials, and the methods of trial development. We cover human papillomavirus (HPV)-associated neoplasia, including cervical cancer, together with endometrial cancer, ovarian cancer, and vulvar cancer. Infrastructure for clinical trials includes a database for trials, templates for protocol development, patient educational material, and financial support for clinical trials. Other critical issues include support from government and charities and government regulations.

Accepted for publication March 16, 2006

DIGITAL OBJECT IDENTIFIER (DOI)

10.1111/j.1525-1438.2007.00667.x About DOI