ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer (ULTRA-LAP)
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|ClinicalTrials.gov Identifier: NCT05862740|
Recruitment Status : Recruiting
First Posted : May 17, 2023
Last Update Posted : May 17, 2023
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ULTRA-LAP is a prospective study is to investigate the safety, efficacy and feasibility of laparoscopic debulking surgery (LDS) for the treatment of patients with advanced ovarian cancer.
The outcomes to measure are:
- Safety: the rate of patients experiencing intra- and post-operative early and late morbidities (within the hospitalization and up to 60 days from surgery)
- Efficacy: the rate of patients in which the surgical target set pre-operatively (complete resection) is achieved by laparoscopy.
- Feasibility: the rate of patients who have their procedure completed by laparoscopy
Patients will undergo laparoscopic debulking surgery (LDS) if the surgical target can be met. If it cannot be achieved by laparoscopy the surgeon will convert to laparotomy.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Procedure: Laparoscopic Debulking Surgery in advanced ovarian cancer Procedure: Standard laparotomic Debulking Surgery in advanced ovarian cancer||Not Applicable|
|Study Type :||Interventional|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Factorial Assignment|
|Intervention Model Description:||Group A is the study group (completed laparoscopic debulking); Group B (conversion to laparotomy) is the control group in which laparoscopy could not be completed|
|Masking:||None (Open Label)|
|Official Title:||ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer: a Feasibility Prospective Study|
|Actual Study Start Date :||January 2, 2022|
|Estimated Primary Completion Date :||December 31, 2026|
|Estimated Study Completion Date :||December 31, 2027|
Experimental: Laparoscopic debulking surgery - LDS
Primary debulking surgery or Interval debulking surgery performed by laparoscopy (P-LDS and I-LDS)
Procedure: Laparoscopic Debulking Surgery in advanced ovarian cancer
Laparoscopic debulking will be conducted until the surgical target is achieved or the operation is converted to laparotomy.
Active Comparator: Debulking surgery - DS
Primary debulking surgery or Interval debulking surgery performed by/converted to laparotomy (PDS and IDS)
Procedure: Standard laparotomic Debulking Surgery in advanced ovarian cancer
Debulking by laparotomy in patients when debulking could not be accomplished by laparoscopy.
- Safety: rate of complications/morbidities [ Time Frame: 60 days ]Safety will be measured as the rate of patients experiencing intra- and post-operative early and late morbidities (within and after the hospitalization up to 60 days from surgery) and it will be compared to the morbidity rate of patients having similar surgery by laparotomy. Complications are going to be graded according to Clavien-Dindo classification.
- Efficacy: rate of complete resection (CR) in group 1 [ Time Frame: 60 days ]Efficacy will be measured as the rate of patients in which the surgical target set pre-operatively is achieved by laparoscopy.
- Feasibility: rate of procedures completed by laparoscopy [ Time Frame: 60 days ]Feasibility will be measured as the rate of patients who have their procedure completed by laparoscopy.
- Progression Free Survival (PFS). [ Time Frame: 5 years ]the time interval from the surgical treatment to the date of the documented first recurrence of disease, by CA 125 (Carbohydrate Antigen 125) and/or CT scan.
- Overall Survival (OS). [ Time Frame: 5 years ]time between surgery and death.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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).
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05862740
|Contact: Matteo Marchetti, Doctoremail@example.com|
|Contact: Marco Noventa, Doctorfirstname.lastname@example.org|
|Azienda Ospedaliera Universitaria di Padova,||Recruiting|
|Padova, Padova, Veneto, Italy, 35128|
|Contact: Matteo Marchetti, MD email@example.com|
|Contact: Marco Noventa, MD firstname.lastname@example.org|
|Sub-Investigator: Carlo Saccardi, Professor|
|Sub-Investigator: Marco Noventa, MD|
|Sub-Investigator: Matteo Marchetti, MD|
|Principal Investigator:||Roberto Tozzi, Professor||Azienda Ospedale Università di Padova|
|Responsible Party:||Roberto Tozzi, Professor and Chair, Azienda Ospedaliera di Padova|
|Other Study ID Numbers:||
AOP2674 ( Other Identifier: University of Padova )
|First Posted:||May 17, 2023 Key Record Dates|
|Last Update Posted:||May 17, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Advanced ovarian cancer
Laparoscopic debulking surgery
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Genital Neoplasms, Female
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type