NCT05862740

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable ovarian-cancer

Timeline
20mo left

Started Jan 2022

Longer than P75 for not_applicable ovarian-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jan 2022Dec 2027

Study Start

First participant enrolled

January 2, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

5 years

First QC Date

March 10, 2023

Last Update Submit

May 8, 2023

Conditions

Ovarian Cancer

Keywords

Ovarian cancerAdvanced ovarian cancerDebulking surgeryMultivisceral surgeryLaparoscopic debulking surgery

Outcome Measures

Primary Outcomes (3)

  • 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.

    60 days

  • 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.

    60 days

  • Feasibility: rate of procedures completed by laparoscopy

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

    60 days

Secondary Outcomes (2)

  • Progression Free Survival (PFS).

    5 years

  • Overall Survival (OS).

    5 years

Study Arms (2)

Laparoscopic debulking surgery - LDS

EXPERIMENTAL

Primary debulking surgery or Interval debulking surgery performed by laparoscopy (P-LDS and I-LDS)

Procedure: Laparoscopic Debulking Surgery in advanced ovarian cancer

Debulking surgery - DS

ACTIVE COMPARATOR

Primary debulking surgery or Interval debulking surgery performed by/converted to laparotomy (PDS and IDS)

Procedure: Standard laparotomic Debulking Surgery in advanced ovarian cancer

Interventions

Laparoscopic Debulking Surgery in advanced ovarian cancerPROCEDURE

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

Laparoscopic debulking surgery - LDS
Standard laparotomic Debulking Surgery in advanced ovarian cancerPROCEDURE

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

Debulking surgery - DS

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Universitaria di Padova,

Padua, Padova, Veneto, 35128, Italy

RECRUITING

Related Publications (6)

  • Elattar A, Bryant A, Winter-Roach BA, Hatem M, Naik R. Optimal primary surgical treatment for advanced epithelial ovarian cancer. Cochrane Database Syst Rev. 2011 Aug 10;2011(8):CD007565. doi: 10.1002/14651858.CD007565.pub2.

    PMID: 21833960RESULT

  • Shih KK, Chi DS. Maximal cytoreductive effort in epithelial ovarian cancer surgery. J Gynecol Oncol. 2010 Jun;21(2):75-80. doi: 10.3802/jgo.2010.21.2.75. Epub 2010 Jun 30.

    PMID: 20613895RESULT

  • Elstrand MB, Sandstad B, Oksefjell H, Davidson B, Trope CG. Prognostic significance of residual tumor in patients with epithelial ovarian carcinoma stage IV in a 20 year perspective. Acta Obstet Gynecol Scand. 2012 Mar;91(3):308-17. doi: 10.1111/j.1600-0412.2011.01316.x. Epub 2012 Jan 9.

    PMID: 22050605RESULT

  • Pomel C, Akladios C, Lambaudie E, Rouzier R, Ferron G, Lecuru F, Classe JM, Fourchotte V, Paillocher N, Wattiez A, Montoriol PF, Thivat E, Beguinot M, Canis M. Laparoscopic management of advanced epithelial ovarian cancer after neoadjuvant chemotherapy: a phase II prospective multicenter non-randomized trial (the CILOVE study). Int J Gynecol Cancer. 2021 Dec;31(12):1572-1578. doi: 10.1136/ijgc-2021-002888. Epub 2021 Oct 20.

    PMID: 34670829RESULT

  • Fagotti A, Gueli Alletti S, Corrado G, Cola E, Vizza E, Vieira M, Andrade CE, Tsunoda A, Favero G, Zapardiel I, Pasciuto T, Scambia G. The INTERNATIONAL MISSION study: minimally invasive surgery in ovarian neoplasms after neoadjuvant chemotherapy. Int J Gynecol Cancer. 2019 Jan;29(1):5-9. doi: 10.1136/ijgc-2018-000012.

    PMID: 30640676RESULT

  • Tozzi R, Noventa M, Saccardi C, Spagnol G, De Tommasi O, Coldebella D, Marchetti M. Feasibility of laparoscopic Visceral-Peritoneal Debulking (L-VPD) in patients with stage III-IV ovarian cancer: the ULTRA-LAP trial pilot study. J Gynecol Oncol. 2024 Mar;35(2):e14. doi: 10.3802/jgo.2024.35.e14. Epub 2023 Oct 16.

    PMID: 37921599DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Roberto Tozzi, Professor

    Azienda Ospedale Università di Padova

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Marchetti, Doctor

CONTACT

0039-049-8213445matteomarchetti91@gmail.com

Marco Noventa, Doctor

CONTACT

0039-049-8213445marco.noventa@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair

Study Record Dates

First Submitted

March 10, 2023

First Posted

May 17, 2023

Study Start

January 2, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

May 17, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)