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

NCT06292286 | Recruiting

• 1 other identifier: UW 22-704
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Ovarian Carcinoma

Outcome Measures

Primary Outcomes (1)

• Complete resection rate

  Rate of complete resection at the time of operation

  12 months

Secondary Outcomes (4)

• 12-month progression-free survival rate

  12 months

• 12-month overall survival rate

  12 months

• Surgical complication rate

  12 months

• Quality of life scale

  12 months

Study Arms (1)

Chemotherapy and surgery arm

EXPERIMENTAL

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

Procedure: Carboplatin or cisplatin; Drug: Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar; Drug: Bevacizumab or biosimilar; Procedure: Cytoreductive surgery

Interventions

Carboplatin or cisplatin PROCEDURE

Carboplatin of cisplatin for 3-6 cycles

Also known as: Paraplatin or Platinol

Chemotherapy and surgery arm

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

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

Also known as: Taxol, Gemzar, Caelyx

Chemotherapy and surgery arm

Bevacizumab or biosimilar DRUG

Optional

Also known as: Avastin or mvasi

Chemotherapy and surgery arm

Cytoreductive surgery PROCEDURE

Cytoreductive surgery after chemotherapy

Chemotherapy and surgery arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Carboplatin; Cisplatin; Paclitaxel; Gemcitabine; liposomal doxorubicin; Bevacizumab; Biosimilar Pharmaceuticals; Cytoreduction Surgical Procedures

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Surgical Procedures, Operative

Study Officials

• Ka Yu Tse

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lesley Lau

CONTACT

852-22554265; lsk382@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Neoadjuvant carboplatin and paclitaxel followed by cytoreductive surgery

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: March 5, 2024
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

HK (1)