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

Recurrent Ovarian Carcinoma Clinical Trial

— SCENIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06292286
• Other study ID #: UW 22-704
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: July 1, 2026

Study information

• Verified date: February 2024
• Source: The University of Hong Kong
• Contact: Lesley Lau
• Phone: 852-22554265
• Email: lsk382[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: July 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Recurrence
• Recurrent Ovarian Carcinoma

Intervention

Procedure:
• Carboplatin or cisplatin
Carboplatin of cisplatin for 3-6 cycles

Drug:
• Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar
Paclitaxel, gemcitabine or liposomal doxorubicin, for 3-6 cycles
• Bevacizumab or biosimilar
Optional

Procedure:
• Cytoreductive surgery
Cytoreductive surgery after chemotherapy

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete resection rate	Rate of complete resection at the time of operation	12 months
Secondary	12-month progression-free survival rate	The time from the first dose of chemotherapy to the first documentation of objective tumor progression (PD) or to death due to any cause, whichever occurs first.	12 months
Secondary	12-month overall survival rate	Overall survival is defined as the time from the first dose of chemotherapy to the date of death due to any cause.	12 months
Secondary	Surgical complication rate	Complications are graded by the Clavien-Dindo classification	12 months
Secondary	Quality of life scale	Different functional scales will be assessed by questionnaires like the EORTC questionnaires where all scales range from 0-100. The higher the score, the greater the intensity of that particular item is.	12 months