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CHRONO: randomized trial of the CHROnology of surgery after Neoadjuvant chemotherapy for Ovarian cancer
  1. Jean-Marc Classe1,
  2. Gwennael Ferron2,
  3. Lobna Ouldamer3,
  4. Tristan Gauthier4,
  5. Sheik Emambux5,
  6. Laurence Gladieff6,
  7. Pierre-Francois Dupre7 and
  8. Amélie Anota8
  1. 1Department of Surgical Oncology, Institut de Cancerologie de l'Ouest, Saint Herblain, France
  2. 2Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse, France
  3. 3Department of Gynecology, Centre Hospitalier Régional Universitaire de Tours, Tours, France
  4. 4Department of Obstetrics and Gynecology, Centre Hospitalier Universitaire de Limoges, Limoges, France
  5. 5Department of Medical Oncology, Centre Hospitalier Universitaire, Poitiers, France
  6. 6Department of Medical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse, France
  7. 7Department of Gynecology and Surgery, Centre Hospitalier Universitaire, Brest, France
  8. 8Department of Biostatistics, Centre Leon Berard, Lyon, France
  1. Correspondence to Professor Jean-Marc Classe, Department of Surgical Oncology, Institut de Cancerologie de l'Ouest, Saint Herblain, Pays de la Loire 44805, France; Jean-Marc.Classe{at}ico.unicancer.fr

Abstract

Background In patients treated for advanced ovarian cancer not suitable for complete primary surgery, interval surgery after three courses of neoadjuvant chemotherapy has been considered standard management since the EORTC randomized trial published in 2010. An alternative approach with delayed surgery after six courses of neoadjuvant chemotherapy was reported in retrospective series.

Primary Objectives To assess the efficacy on progression free survival of interval cytoreduction surgery after three cycles of neoadjuvant chemotherapy compared with delayed surgery after six cycles of neoadjuvant chemotherapy.

Study Hypothesis In women with ovarian cancer not suitable for primary surgical cytoreduction, surgery after six cycles of neoadjuvant chemotherapy will prove better disease-free survival than cytoreductive surgery after only three cycles.

Trial Design CHRONO is a multicenter, randomized phase III trial. After three courses of neoadjuvant chemotherapy, eligible patients will be randomized (1:1) to either completion surgery followed by an additional five cycles of chemotherapy (control arm) or an additional three cycles of neoadjuvant chemotherapy followed by completion surgery and then two additional cycles of chemotherapy (experimental arm). Patients in both groups will receive eight total cycles of chemotherapy.

Major Inclusion/Exclusion Criteria The main inclusion criteria are histologically confirmed epithelial high-grade serous or endometrioid ovarian cancer, documented FIGO stage IIIB–IVA unsuitable for complete primary surgery but considered resectable after three courses of neoadjuvant chemotherapy. The main exclusion criteria are mucinous, clear cell, carcinosarcoma, or low-grade serous histologies.

Primary Endpoint The primary endpoint is progression-free survival.

Sample Size 210 eligible patients

Estimated Dates for Completing Accrual and Presenting Results The estimated date for completing accrual will be Q2 2023. The estimated date for presentation of the first results is Q3 2028.

Trial Registration Number NCT03579394.

  • Surgery
  • Ovarian Cancer
  • Gynecologic Surgical Procedures

Data availability statement

All data relevant to the study are included in the article.

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Data availability statement

All data relevant to the study are included in the article.

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Footnotes

  • Contributors J-MC takes responsibility for the integrity of this manuscript. J-MC, AA: study concept, and design. The manuscript has been read and approved by all authors, and all have been involved in drafting the article, critically revising it, and approving its final version. J-MC study supervision. J-MC is the guarantor.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests J-MC: lectures/other education events from Astra Zeneca, GSK, and Clovis.

  • Provenance and peer review Commissioned; internally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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