Secondary Interval Cytoreductive Surgery in Platinum-sensitive Recurrent Epithelial Ovarian Cancer

Last updated: February 27, 2024
Sponsor: The University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Bevacizumab or biosimilar

Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar

Carboplatin or cisplatin

Clinical Study ID

NCT06292286
UW 22-704
  • Ages > 18
  • Female

Study Summary

About 80% of advanced ovarian cancer patients recurred in 2-3 years. Secondary cytoreduction benefits selected patients who have high chance of complete resection. Whether secondary interval surgery can be used at recurrence is not known.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically diagnosed EOC, fallopian tube or primary peritoneal carcinoma
  • >= 3 cycles of platinum-based chemotherapy, with or without bevacizumab and / orPARPi, at primary setting
  • Platinum-free interval should be >=6 months from the last dose of platinum-basedchemotherapy
  • Upfront SCR not feasible
  • Patients should have Eastern Cooperative Oncology Group (ECOG) performance score 0 to 2 within 28 days prior to recruitment.
  • Patients must have adequate bone marrow, renal, hepatic and neurological functionwithin 28 days prior to the start of treatment.

Exclusion

Exclusion Criteria:

  • Non-epithelial or borderline tumors are excluded
  • Patients who have with concurrent malignancy within five years (except for basal orsquamous cell skin cancer, in-situ breast cancer, stage 1a grade 1-2 endometrioidendometrial carcinoma without lymphovascular invasion) are excluded.
  • Patients using more than one line of chemotherapy are excluded.
  • Patients who have platinum-resistant or refractory recurrence are excluded.
  • Patients having second relapse or beyond are excluded.
  • Patients who have contraindications to operation, e.g., unresolved thrombocytopenia,bowel obstruction in the last 4 weeks prior to enrolment

Study Design

Total Participants: 18
Treatment Group(s): 4
Primary Treatment: Bevacizumab or biosimilar
Phase:
Study Start date:
November 01, 2023
Estimated Completion Date:
July 01, 2026

Study Description

Our study aims to evaluate the complete resection rate at interval cytoreductive surgery for recurrent ovarian cancer patients, and to determine the safety and survival outcomes of this approach.

Connect with a study center

  • The University of Hong Kong

    Hong Kong,
    Hong Kong

    Active - Recruiting

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