Laparoscopic surgery for advanced ovarian cancer treatment
ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer: a Feasibility Prospective Study
This study is testing if a less invasive type of surgery can safely and effectively remove advanced ovarian cancer in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Azienda Ospedaliera di Padova Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Padova, Padova, Veneto) |
| Trial ID | NCT05862740 on ClinicalTrials.gov |
What this trial studies
The ULTRA-LAP study investigates the safety, efficacy, and feasibility of laparoscopic debulking surgery (LDS) for patients with advanced ovarian cancer. It aims to determine the rate of complete resection of visible disease achieved through laparoscopy, as well as the rates of intra- and post-operative complications. Patients will undergo an exploratory laparoscopy to confirm eligibility, and if the surgical target cannot be met, they will receive neo-adjuvant chemotherapy before reconsideration for surgery. The study will enroll a minimum of 62 patients over approximately four years.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 and above with advanced epithelial ovarian cancer (stage II-IV) who are eligible for primary or interval debulking surgery.
Not a fit: Patients with significant comorbidities or poor performance status that preclude radical surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective surgical options for patients with advanced ovarian cancer.
How similar studies have performed: While laparoscopic approaches have been explored in other studies, the specific application of LDS in advanced ovarian cancer is relatively novel and under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with advanced epithelial ovarian cancer (II-IV Stage FIGO) candidates to PDS (primary debulking surgery) or IDS (interval debulking surgery: neoadjuvant chemotherapy followed by IDS). * Participant is willing and able to give informed consent for participation in the study. * Female aged 18 years or above. * Primary diagnosis of advanced epithelial ovarian cancer (tubal and peritoneal cancer included). Exclusion Criteria: * Comorbidities non-allowing for radical surgery * Poor Performance Status (Karnofsky Index \< 70) * Concomitant or past history of malignancy, regardless of treatment status * Recent or past story of pancreatitis or hepatitis * Recent or past story of pleural effusion or lung injuries or respiratory failure * Cardiac major pathologies
Where this trial is running
Padova, Padova, Veneto
- Azienda Ospedaliera Universitaria di Padova, — Padova, Padova, Veneto, Italy (Recruiting)
Study contacts
- Principal investigator: Roberto Tozzi, Professor — Azienda Ospedale Università di Padova
- Study coordinator: Matteo Marchetti, Doctor
- Email: matteomarchetti91@gmail.com
- Phone: 0039-049-8213445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.