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An international, phase III randomized trial in patients with mucinous epithelial ovarian cancer (mEOC/GOG 0241) with long-term follow-up: and experience of conducting a clinical trial in a rare gynecological tumor

Lookup NU author(s): Dr Graham Dark


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© 2019 The Authors Objectives: We evaluated four different treatment regimens for advanced-stage mucinous epithelial ovarian cancer. Methods: We conducted a multicenter randomized factorial trial (UK and US). Patients were diagnosed with primary mEOC: FIGO stage II–IV or recurrence after stage I disease. Treatment arms were paclitaxel-carboplatin, oxaliplatin-capecitabine, paclitaxel-carboplatin-bevacizumab, or oxaliplatin-capecitabine-bevacizumab. Chemotherapy was given 3-weekly for 6 cycles, and bevacizumab (3-weekly) was continued as maintenance (for 12 cycles). Endpoints included overall-survival (OS), progression-free survival (PFS), toxicity and quality of life (QoL). Results: The trial stopped after 50 patients were recruited due to slow accrual. Median follow-up was 59 months. OS hazard ratios (HR) for the two main comparisons were: 0.78 (p = 0.48) for Oxal-Cape vs. Pac-Carbo (each with/without bevacizumab), and 1.04 (p = 0.92) for bevacizumab vs. no bevacizumab. Corresponding PFS HRs were: 0.84 and 0.80. Retrospective central pathology review revealed only 45% (18/40) cases with available material had confirmed primary mEOC. Among these, OS HR for Oxal-Cape vs. Pac-Carbo was 0.36 (p = 0.14); PFS HR = 0.62 (p = 0.40). Grade 3–4 toxicity was seen in 61% Pac-Carbo, 61% Oxal-Cape, 54% Pac-Carbo-Bev, and 85% Oxal-Cape-Bev. QoL was similar between the four arms. Conclusion: mEOC/GOG0241 represents an example of a randomized rare tumor trial. Logistical challenges led to early termination, including difficulties in local histopathological diagnosis and accessing drugs outside their labelled indication. There was misalignment between central funders who support clinical trials in rare cancers and the deprioritisation of such work by those managing and funding research at a local level. Rare cancer trials should include centralised pathology review before treatment. Clinical trial registry number: ISRCTN83438782.

Publication metadata

Author(s): Gore M, Hackshaw A, Brady WE, Penson RT, Zaino R, McCluggage WG, Ganesan R, Wilkinson N, Perren T, Montes A, Summers J, Lord R, Dark G, Rustin G, Mackean M, Reed N, Kehoe S, Frumovitz M, Christensen H, Feeney A, Ledermann J, Gershenson DM

Publication type: Article

Publication status: Published

Journal: Gynecologic Oncology

Year: 2019

Volume: 153

Issue: 3

Pages: 541-548

Print publication date: 01/06/2019

Online publication date: 18/04/2019

Acceptance date: 26/03/2019

Date deposited: 30/04/2019

ISSN (print): 0090-8258

ISSN (electronic): 1095-6859

Publisher: Academic Press Inc.


DOI: 10.1016/j.ygyno.2019.03.256


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Funder referenceFunder name
Cancer Research UK (C1569/A9620)
Gynecologic Oncology Group Statistical and Data Center (CA 37517),
National Cancer Institute grants to the Gynecologic Oncology Group Administrative Office (CA 27469)
NRG Oncology (1 U10 CA180822)
NRG Operations (U10CA180868)