TY - JOUR T1 - Definitions for Response and Progression in Ovarian Cancer Clinical Trials Incorporating RECIST 1.1 and CA 125 Agreed by the Gynecological Cancer Intergroup (GCIG) JF - International Journal of Gynecologic Cancer JO - Int J Gynecol Cancer SP - 419 LP - 423 DO - 10.1097/IGC.0b013e3182070f17 VL - 21 IS - 2 AU - Gordon John Sampson Rustin AU - Ignace Vergote AU - Elizabeth Eisenhauer AU - Eric Pujade-Lauraine AU - Michael Quinn AU - Tate Thigpen AU - Andreas du Bois AU - Gunnar Kristensen AU - Anders Jakobsen AU - Satoru Sagae AU - Kathryn Greven AU - Mahesh Parmar AU - Michael Friedlander AU - Andres Cervantes AU - Jan Vermorken Y1 - 2011/01/01 UR - http://ijgc.bmj.com/content/21/2/419.abstract N2 - The Gynecological Cancer Intergroup (GCIG) has previously reached consensus regarding the criteria that should be used in clinical trial protocols to define progression-free survival after first-line therapy as well as the criteria to define response to treatment in recurrent disease using the serum marker CA 125 and has specified the situations where these criteria should be used. However, the publications did not include detailed definitions, nor were they written to accommodate the new version of Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1) now available. Thus, we recommend that the definitions described later in detail are incorporated into clinical trial protocols to maintain consistency. The criteria for defining progression are now acceptable in clinical trials of recurrent disease as they have since been validated (Pujade-Lauraine, personal communication, 2010). The GCIG requests that data from all clinical trials using these definitions are made available to GCIG trial centers so that continual validation and improvement can be accomplished. These definitions were developed from analyzing patients receiving cytotoxic chemotherapy and have not yet been validated in patients receiving molecular targeting agents. ER -