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Neoadjuvant chemoteraphy in unresectable ovarian cancer with olaparib and weekly carboplatin plus paclitaxel: a phase II, open label multicenter study (NUVOLA trial)
  1. Claudia Marchetti,
  2. Riccardo Tudisco,
  3. Vanda Salutari,
  4. Antonella Pietragalla,
  5. Giovanni Scambia and
  6. Anna Fagotti
  1. Department of Woman, Child and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
  1. Correspondence to Anna Fagotti, Woman and Child's Health Department, Universita Cattolica del Sacro Cuore Facolta di Medicina e Chirurgia, Roma, 00168 Roma RM, Italy; annafagotti70{at}gmail.com

Abstract

Background Neoadjuvant chemotherapy with interval debulking surgery represents an alternative treatment for advanced ovarian cancer. Currently, there are few data about the use of poly adenosine diphosphate-ribose polymerase inhibitors in the neoadjuvant setting.

Primary Objective To evaluate whether the administration of olaparib in combination with standard chemotherapy in the neoadjuvant setting can improve tumor response.

Study Hypothesis The addition of a poly adenosine diphosphate-ribose polymerase inhibitor to standard chemotherapy will achieve a higher response rate in BRCA mutated patients compared with standard chemotherapy

Trial Design This is a multicenter, phase II, single arm, open label trial. Eligible patients will receive three cycles of weekly carboplatin plus paclitaxel, and intermittent olaparib administration. Responding patients will undergo an interval debulking surgery with pathological evaluation of response to chemotherapy.

Major Eligibility Criteria Patients must have histologically confirmed International Federation of Gynecology and Obstetrics stages III–IV primary ovarian, peritoneal, or fallopian tube cancers, high grade serous or endometrioid histology, not suitable for primary cytoreductive surgery with a documented BRCA1 or BRCA2 germline and/or somatic mutation.

Primary Endpoint Rate of complete pathological response after three cycles of the experimental chemotherapy regimen.

Sample Size A total of 35 patients will be enrolled in the study.

Estimated Dates for Completing Accrual and Presenting Results Expected complete 42 accrual in January 2022, with presentation of results by June 2022.

Trial Registration Number NCT04261465

  • ovarian cancer
  • ovarian neoplasms
  • BRCA1 protein
  • BRCA2 protein

Data availability statement

There are no data in this work.

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Data availability statement

There are no data in this work.

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Footnotes

  • Twitter @annafagottimd

  • Contributors CM is responsible for study design, drafting the manuscript, statistical analysis, and data interpretation. RT, VS, and AP are responsible for the acquisition and quality control of the data. GS and AF are responsible for the critical revision of the manuscript for important intellectual content.

  • Funding The study is funded by AstraZeneca.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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