LYmphadenectomy After NeoAdjuvant Chemotherapy (NCT01724944) | Clinical Trial Compass
UnknownPhase 1/2
LYmphadenectomy After NeoAdjuvant Chemotherapy
Italy65 participantsStarted 2011-02
Plain-language summary
The purpose of this study is to determine the role of lymphadenectomy in advenced ovarian cancer patients at the time of interval debulking surgery after neoadjuvant chemiotherapy.
Moreover it is a prospective trial, aimed to investigate the prognostic role of sistematic lymphadenectomy in terms of percentage of micrometastases detected, morbidity (complications rate), progression free interval, overall survival, recurrence pattern.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 18 and 75 years
* Patients affected by advanced ovarian cancer (FIGO stage III-IV) who underwent \> 2 to \<7 cycles of neoadjuvant chemotherapy based on platinum and taxanes.
* Clinical response (instrumental and serological) complete or partial.
* Residual intra-abdominal tumor \<1 cm.
* Absence of disease macroscopically evident in lymph nodes (\> 1 cm)
* Life expectancy of at least 4 weeks
* ECOG PS ≤ 2
* Adequate respiratory function, hepatic, cardiac, bone marrow and renal function (creatinine clearance\> 60 mL / min according to the Cockroft formula)
* Patient psychologically able to follow the study procedures
Exclusion Criteria:
* Patients with severe impairment of lung function, or liver failure, such as not to allow access in safety in the operating room.
* Not epithelial ovarian neoplasms or borderline tumors
* Other invasive cancer in the last 5 years or signs of recurrence or activity
* Patients with intra-abdominal residual tumor\> 1 cm
* Patients with the presence of bulky nodes (\> 1 cm) in the intra-operative evaluation
* Diseases of the lymphatic system (including lymphatic edema of unknown origin)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of positive lymph nodes after neoadjuvant chemotherapy
Timeframe: 6 months
2
Evaluation of complications related to the surgical procedure