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New treatment option for Ovarian Cancer
Official title Personalized Timing of Interval Debulking Surgery in Advanced Ovarian Cancer
ClinicalTrials.gov ID: NCT07023484
What this study is testing
What is Carboplatin plus Paclitaxel?
Carboplatin plus Paclitaxel is an investigational medicine, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients aged 18 years old or older
- Patients with Eastern Cooperative Oncology Group score 0-1 within 28 days prior to recruitment
- Patients who can sign the informed consent
- Patients with stage III-IV histologically or cytologically confirmed epithelial ovarian cancer (EOC), fallopian tube or primary peritoneal cancer not...
- Patients who have baseline computed tomography (CT) of thorax, abdomen and pelvis.
You likely can't join if
- Patients who have borderline malignancy, or non-EOC like germ cell or sex cord tumor, or metastatic diseases from other origins
- Patients with mucinous and neuroendocrine histology
- Patients with history of other malignancies within five years
- Patients who are eligible for primary debulking surgery (PDS)
- Patients who cannot undergo PDS because of parametrial and/or vaginal involvement alone
- Patients who are not fit for PDS because of medical morbidities or refusal of operation
See the full eligibility criteria
- Patients aged 18 years old or older
- Patients with Eastern Cooperative Oncology Group score 0-1 within 28 days prior to recruitment
- Patients who can sign the informed consent
- Patients with stage III-IV histologically or cytologically confirmed epithelial ovarian cancer (EOC), fallopian tube or primary peritoneal cancer not amenable for PDS
- Patients who have baseline computed tomography (CT) of thorax, abdomen and pelvis.
- Patients who are planned for neoadjuvant chemotherapy (NACT) using 3-weekly carboplatin and paclitaxel. Those who have received one cycle of NACT may be eligible if the CA125 schedule of the study group can be matched.
- Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal)
- Patients who agree for chemotherapy and interval debulking surgery (IDS) if the disease becomes operable after NACT
- Patients with adequate hematologic, liver and renal functions for chemotherapy
- Patients who agree to receive adjuvant chemotherapy after IDS. The total number of NACT and adjuvant chemotherapy should be four or above, up to maximum of 9 cycles.
- Patients who have childbearing potential should practice highly effective contraception throughout the study until at least 30 days after completion of the treatment.
- Patients must have either germline and / or somatic BRCA test, or homologous recombination deficiency (HRD) test.
- Patients who have borderline malignancy, or non-EOC like germ cell or sex cord tumor, or metastatic diseases from other origins
- Patients with mucinous and neuroendocrine histology
- Patients with history of other malignancies within five years
- Patients who are eligible for primary debulking surgery (PDS)
- Patients who cannot undergo PDS because of parametrial and/or vaginal involvement alone
- Patients who are not fit for PDS because of medical morbidities or refusal of operation
- Patients who have already started NACT outside the study centers, except those who have received only one cycle within 7 days and the baseline CA125 value within 3 days of NACT (normal cut-off 35 U/ml) is available
- Patients who participate in other treatment studies
- Patients who are pregnant or breastfeeding
- Patients who have contraindications to platinum-based chemotherapy
- Patents with active tuberculosis, history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, China
- Shenzhen, China
- Chai Wan, Hong Kong
- Hong Kong, Hong Kong
- Kwun Tong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, China; Shenzhen, China; Chai Wan, Hong Kong; Hong Kong, Hong Kong; Kwun Tong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.