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

NCT ID: NCT06292286

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Recurrent Ovarian Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Neoadjuvant carboplatin and paclitaxel followed by cytoreductive surgery
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemotherapy and surgery arm

Patients receive platinum-based chemotherapy with or without bevacizumab, and then undergo cytoreductive operation, for the first recurrence of EOC.

Group Type EXPERIMENTAL

Carboplatin or cisplatin

Intervention Type PROCEDURE

Carboplatin of cisplatin for 3-6 cycles

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

Intervention Type DRUG

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

Bevacizumab or biosimilar

Intervention Type DRUG

Optional

Cytoreductive surgery

Intervention Type PROCEDURE

Cytoreductive surgery after chemotherapy

Interventions

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Carboplatin or cisplatin

Carboplatin of cisplatin for 3-6 cycles

Intervention Type PROCEDURE

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

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

Intervention Type DRUG

Bevacizumab or biosimilar

Optional

Intervention Type DRUG

Cytoreductive surgery

Cytoreductive surgery after chemotherapy

Intervention Type PROCEDURE

Other Intervention Names

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Paraplatin or Platinol Taxol, Gemzar, Caelyx Avastin or mvasi

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ka-Yu Tse

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ka Yu Tse

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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The University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Lesley Lau

Role: CONTACT

852-22554265

Facility Contacts

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Lesley Lau

Role: primary

852-22554518

Ka Yu Tse

Role: backup

852-22554265

Other Identifiers

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UW 22-704

Identifier Type: -

Identifier Source: org_study_id

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