RecruitingNot ApplicableNCT06292286

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

Secondary Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Platinum-sensitive Recurrent Epithelial Ovarian Cancer Patients - a Pilot Study


Sponsor

The University of Hong Kong

Enrollment

18 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • Histologically diagnosed EOC, fallopian tube or primary peritoneal carcinoma
  • \>= 3 cycles of platinum-based chemotherapy, with or without bevacizumab and / or PARPi, at primary setting
  • Platinum-free interval should be \>=6 months from the last dose of platinum-based chemotherapy
  • 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 function within 28 days prior to the start of treatment.

Exclusion Criteria6

  • Non-epithelial or borderline tumors are excluded
  • Patients who have with concurrent malignancy within five years (except for basal or squamous cell skin cancer, in-situ breast cancer, stage 1a grade 1-2 endometrioid endometrial 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

Interventions

PROCEDURECarboplatin or cisplatin

Carboplatin of cisplatin for 3-6 cycles

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

Paclitaxel, gemcitabine or liposomal doxorubicin, for 3-6 cycles

DRUGBevacizumab or biosimilar

Optional

PROCEDURECytoreductive surgery

Cytoreductive surgery after chemotherapy


Locations(1)

The University of Hong Kong

Hong Kong, Hong Kong

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NCT06292286


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