The University of Hong Kong
Hong Kong
Location status: Recruiting
Location contact
Iris Tang
CONTACT
Ka Yu Tse, MBBS, MMedSc, PhD, FRCOG
PRINCIPAL_INVESTIGATOR
Lesley Lau, MPhil
CONTACT
NCT Number: NCT07022535
About 70% of epithelial ovarian cancer patients are diagnosed at advanced stage. When primary optimal surgery is not possible, neoadjuvant chemotherapy will followed by interval debulking surgery is one treatment option. However, there is no consensus on the optimal timing of the surgery. CA125 is a well-known tumor marker in ovarian cancer. Its kinetic change has been proven to correlate with the patients' response to chemotherapy and chance of optimal resection. This study aims to utilize the kinetic change of CA125 to customize the timing of surgery for individual patients.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 2
Hong Kong
Location status: Recruiting
Iris Tang
CONTACT
Ka Yu Tse, MBBS, MMedSc, PhD, FRCOG
PRINCIPAL_INVESTIGATOR
Lesley Lau, MPhil
CONTACT
Recruited patients will have additional CA125 at 4th (before administration of chemotherapy), and 5th week after the first cycle of chemotherapy. CA-125 ELIMination Rate Constant K (KELIM) will be determined. Patients with KELIM =>1 will receive radiological assessment and undergo internal debulking surgery if the disease is operable. Patients with KELIM <1 will have alternative management, such as addition of bevacizumab or changing to dose-dense chemotherapy, and defer the interval debulking surgery
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(i) Patients with KELIM >=1 will receive radiological assessment and undergo interval debulking surgery if the disease is operable.
(ii) Patients with KELIM <1 will have alternative management, such as addition of bevacizumab or changing to dose-dense chemotherapy, and defer the interval debulking surgery
Chemotherapy as neaodjuvant chemotherapy
Interval debulking surgery
Other names: cytoreductive surgery
Time frame: Up to 24 months
The likelihood of CC0 in patients who undergo IDS when KELIM reaches 1 or above
Time frame: Up to 24 weeks
The sensitivity of KELIM in predicting CC0
Time frame: Up to 24 weeks
The time required for KELIM to reach >=1 in EOC patients receiving NACT
Time frame: Up to 1 year
The complication rates of surgery based on the Clavien-Dindo classification and chemotherapy based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
Expression levels of biomarkers before and after chemotherapy
Contact information is provided by the study sponsor or research team.
Iris Tang
CONTACT
Lesley Lau, MPhil
CONTACT
The University of Hong Kong
Other
Personalised Timing of Interval Debulking Surgery Based on KELIM After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer - a Pilot Study
Acronym: PRESELECT-0
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05080946
Adnexal Diseases, Endocrine Gland Neoplasms
Tampa, Florida, United States
View Trial DetailsNCT05071937
Adnexal Diseases, Endocrine Gland Neoplasms
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT04701645
Adnexal Diseases, Endocrine Gland Neoplasms
Boston, Massachusetts, United States
View Trial DetailsNCT06290193
Adnexal Diseases, Endocrine Gland Neoplasms
Basking Ridge, New Jersey, United States
View Trial Details