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ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer

ConditionOvarian Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAzienda Ospedaliera di Padova

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Laparoscopic Debulking Surgery in advanced ovarian cancer

    Procedure/Surgery

    Laparoscopic debulking will be conducted until the surgical target is achieved or the operation is converted to laparotomy.

  • Standard laparotomic Debulking Surgery in advanced ovarian cancer

    Procedure/Surgery

    Debulking by laparotomy in patients when debulking could not be accomplished by laparoscopy.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Laparoscopic debulking surgery - LDSExperimental treatment 1 intervention
Group B: Debulking surgery - DSActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety: rate of complications/morbidities

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.

Time frame
60 days
2

Efficacy: rate of complete resection (CR) in group 1

Efficacy will be measured as the rate of patients in which the surgical target set pre-operatively is achieved by laparoscopy.

Time frame
60 days
3

Feasibility: rate of procedures completed by laparoscopy

Feasibility will be measured as the rate of patients who have their procedure completed by laparoscopy.

Time frame
60 days

Secondary outcomes

1

Progression Free Survival (PFS).

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.

Time frame
5 years
2

Overall Survival (OS).

time between surgery and death.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Ospedaliera di Padova

Lead sponsor

University of Padova

Collaborator

Source ClinicalTrials.gov
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