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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