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

NCT ID: NCT06292286

Condition: Recurrent Ovarian Carcinoma

Conditions: Official terms:
Carcinoma, Ovarian Epithelial
Recurrence
Paclitaxel
Bevacizumab
Carboplatin
Gemcitabine
Doxorubicin
Liposomal doxorubicin

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Neoadjuvant carboplatin and paclitaxel followed by cytoreductive surgery

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Carboplatin or cisplatin
Description: Carboplatin of cisplatin for 3-6 cycles
Arm group label: Chemotherapy and surgery arm

Other name: Paraplatin or Platinol

Intervention type: Drug
Intervention name: Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar
Description: Paclitaxel, gemcitabine or liposomal doxorubicin, for 3-6 cycles
Arm group label: Chemotherapy and surgery arm

Other name: Taxol, Gemzar, Caelyx

Intervention type: Drug
Intervention name: Bevacizumab or biosimilar
Description: Optional
Arm group label: Chemotherapy and surgery arm

Other name: Avastin or mvasi

Intervention type: Procedure
Intervention name: Cytoreductive surgery
Description: Cytoreductive surgery after chemotherapy
Arm group label: Chemotherapy and surgery arm

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.

Detailed 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.

Criteria for eligibility:
Criteria:
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

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: The University of Hong Kong

Address:
City: Hong Kong
Country: Hong Kong

Status: Recruiting

Contact:
Last name: Lesley Lau

Phone: 852-22554518

Contact backup:
Last name: Ka Yu Tse

Phone: 852-22554265
Email: tseky@hku.hk

Investigator:
Last name: Ka Yu Tse, MBBS, PhD
Email: Principal Investigator

Start date: November 1, 2023

Completion date: July 1, 2026

Lead sponsor:
Agency: The University of Hong Kong
Agency class: Other

Source: The University of Hong Kong

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06292286

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