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JOURNAL ONKOLOGIE – STUDIE
OMEGA-2

Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer

Rekrutierend

NCT-Nummer:
NCT05180864

Studienbeginn:
März 2024

Letztes Update:
29.03.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Stomach Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Amsterdam UMC

Collaborator:
-

Studienleiter

Suzanne S. Gisberts, MD, PhD
Study Chair
Amsterdam UMC
Wietse J. Eshuis, MD, PhD
Principal Investigator
Amsterdam UMC
Mark I. van Berge Henegouwen, MD, PhD
Principal Investigator
Amsterdam UMC

Kontakt

Studienlocations
(3 von 16)

University Medical Center of the Johannes Gutenberg University
Mainz
(Rheinland-Pfalz)
GermanyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliera Universitaria
Siena
ItalyNoch nicht rekrutierend» Google-Maps
Ziekenhuis Groep Twente
Almelo
NetherlandsNoch nicht rekrutierend» Google-Maps
Antoni van Leeuwenhoek
Amsterdam
NetherlandsNoch nicht rekrutierend» Google-Maps
Rijnstate ziekenhuis
Arnhem
NetherlandsNoch nicht rekrutierend» Google-Maps
Universitait Medisch Centrum Groningen
Groningen
NetherlandsNoch nicht rekrutierend» Google-Maps
Zuyderland ziekenhuis
Heerlen
NetherlandsNoch nicht rekrutierend» Google-Maps
Medisch Centrum Leeuwarden
Leeuwarden
NetherlandsNoch nicht rekrutierend» Google-Maps
Leids Universitair Medisch Centrum
Leiden
NetherlandsNoch nicht rekrutierend» Google-Maps
Erasmus Medisch Centrum
Rotterdam
NetherlandsNoch nicht rekrutierend» Google-Maps
Elisabeth Tweesteden ziekenhuis
Tilburg
NetherlandsNoch nicht rekrutierend» Google-Maps
Universitair Medisch Centrum Utrecht
Utrecht
NetherlandsNoch nicht rekrutierend» Google-Maps
Oxford University Hospitals
Oxford
United KingdomNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Primary objective:

The primary study objective is evaluate whether preservation of the omentum distal to the

gastroepiploic vessels in gastrectomy for cancer is non-inferior to complete omentectomy in

terms of three-year overall survival.

Secondary objectives:

Comparing the two study arms with regard to:

- Operating time

- Intraoperative blood loss

- Intraoperative complications

- Postoperative complications, defined according to the Clavien-Dindo classification25 and

comprehensive complication index (CCI)

- Distribution of lymph node metastases

- R0-resection rate

- Rate of malignant cells in cytology

- Molecular sub classification of gastric cancer

- ICG fluorescent enhancement of omentum in omentum preservation group (in centers that

have ICG fluorescence available)

- Protocol compliance to allocated treatment

- Hospital stay, defined as time interval between date of surgery and date of hospital

discharge

- Readmission rate within 30-days after surgery

- Reintervention rate within 30-days after surgery

- Reoperation rate within three years after surgery

- Quality of life at baseline, 3, 6, 9, 12 and 24 months, the following questionnaires

will be used: EQ-5D-5L, QLQ-C30, QLQ-OG25, CIPN, Happiness, HADS and work productivity

- 3- & 5-year disease-free survival, defined as the period of time from operation to

locoregional recurrence, peritoneal recurrence, distant metastases, second gastric

cancer or death from any cause. Patients alive and free of all these events will be

censored at the last follow-up.

- 5-year overall survival, defined as the period of time from operation to death from any

cause. Patients alive and free of all these events will be censored at the last

follow-up.

- Cost-effectiveness

Study design:

OMEGA is a randomized controlled, open, parallel, non-inferiority, multicenter trial.

Eligible patients have to be operable (ASA <4) with resectable (≦cT4aN3bM0) gastric cancer.

Patients will be randomized in a 1:1 ratio between radical (sub)total gastrectomy with

omentum preservation or complete omentectomy. Patients will be stratified according to

center, neoadjuvant therapy and type of surgery (total or subtotal gastrectomy). The primary

endpoint is overall survival at three-years after the operation. In total, 654 patients will

be randomized.

Sample size:

The primary endpoint is three-year overall survival. According to survival numbers from the

Dutch Cancer Registry (NKR), three-year overall survival after gastrectomy is approximately

50% in the Netherlands. Under the common assumption of exponential survival times, a hazard

ratio of 0.862 under the alternative hypothesis, at least 50% and 45% expected events (i.e.,

death) in the control arm and experimental arm, respectively, at the minimum follow-up of

three years, 298 events are needed in total to achieve 80% power at a one-sided significance

level of 5% with a non-inferiority hazard ratio of 1.15 (PASS 15 Power Analysis and Sample

Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass), resulting in

314 patients per study arm. Dropouts will be rare (mostly due to loss to follow-up, which is

quite rare in cancer patients), with proportion dropping out expected to be at most 5%. After

correction for drop-out we plan to include 327 patients in each of the two arms (654 in

total).

Statistical analysis:

Primary endpoint: Descriptive statistics will be calculated to summarize patients' groups

included in each of trial arms.

Mean and standard deviation will be presented for normally distributed continuous variables.

Median plus interquartile-range (IQR) will be presented continuous variables that are skewed

and for ordinal variables. Dichotomous and nominal data will be summarized by means of

frequencies and percentages.

Non-inferiority of the experimental treatment in terms of overall survival will be tested

using Cox-regression. Non-inferiority will be concluded if the upper limit of the 90%

confidence interval falls below the non-inferiority hazard ratio of 1.15, corresponding to a

one-sided non-inferiority test at significance level of 5%. Survival will be presented

graphically using Kaplan-Meier curves. All analyses will be according to the intention to

treat principle. A per protocol analysis will also be performed. The experimental treatment

will be declared non-inferior if non-inferiority is shown in both the intention to treat and

the per protocol analysis.

Secondary endpoint: as independent samples t-test for normally-distributed continuous

outcomes, Mann-Whitney tests for continuous outcomes that are not normally distributed or

ordinal outcomes. Categorical outcomes will be compared using chi-square test or Fisher's

exact test in case of low (expected) cell counts. Repeatedly measured outcomes will be

compared between arms using linear mixed models. Secondary time-to-event outcomes will be

compared the using log-rank test. Secondary endpoints will be tested at a two-sided

significance level of 5%. Effect sizes suitable for the type of outcome measure will be

provided (mean differences, ratio of geometric means, relative risks, hazard ratios) together

with their 95% confidence interval.

Subgroup analysis for the effect of experimental treatment on overall survival will be

performed for the follow subgroups: patient characteristics (age, male/female),

diffuse/intestinal type gastric tumor, subtotal/total gastrectomy, and minimally

invasive/open gastrectomy. Effect modification will use Cox regression with the subgroup

variable, the arm and their two-way interaction. Additionally, stratified analyses will be

performed where HR is calculated separately in each of the subgroups.

Quality of life data will be graphically represented across all time points and analyzed

according to the manuals and will presented as domain and summarized scores. Questionnaire

outcome comparisons will be analyzed using linear mixed models.

Ein-/Ausschlusskriterien

Inclusion criteria

- Primary resectable gastric adenocarcinoma, clinical stage T1-4aN0-3M0

- ASA 1-3 (able to undergo surgery)

- Scheduled for open or minimally invasive (sub)total gastrectomy with modified

D2-lymphadenectomy, with or without perioperative chemotherapy

- Age above 18

- Able to complete questionnaires in Dutch, English or Italian

- Written informed consent

- Esophageal invasion < 2 cm defined from the upper margin of the gastric rugae as

determined by endoscopy

Exclusion Criteria:

- Gastric cancer clinically staged as T1N0

- Locally advanced gastric cancer requiring multi-visceral resection

- Pregnancy

- Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine

tumor (pNET) <2cm, and gastrointestinal stromal tumor (GIST) <2cm), unless no evidence

of disease and diagnosed more than three years before diagnosis of gastric cancer, or

with a life expectancy of more than five years from date of inclusion

- Serious concomitant systemic disorders that would compromise the safety of the patient

or his/her ability to complete the study, at the discretion of the investigator

- Previous gastric or omental surgery, with the exclusion of a gastric perforation

Indication for thoracotomy/thoracoscopy

Studien-Rationale

Primary outcome:

1. Overall survival (Time Frame - 3 years after surgery):
Overall survival is defined as the period of time from operation to death from any cause. Patients alive and free of all these events will be censored at the last follow-up



Secondary outcome:

1. 5-year overall survival (Time Frame - 5 years after surgery):
Defined as the period of time from operation to death from any cause. Patients alive and free of all these events will be censored at the last follow-up

2. Intraoperative blood loss (Time Frame - Intraoperative):
The volume of blood loss in milliliters during surgery

3. Postoperative complications (Time Frame - Within 30-days after surgery):
Defined according to the Clavien-Dindo classification and comprehensive complication index (CCI)

4. Distribution of lymph node metastases (Time Frame - Pathology report 1/2 weeks after surgery):
The distribution of lymph node metastases in gastric cancer

5. R0-resection rate (Time Frame - Pathology report 1/2 weeks after surgery):
R0-resection rate of the distal and proximal margin, according to the College of American Pathologists

6. Rate of malignant cells in cytology (Time Frame - Pathology report 1/2 weeks after surgery):
The proportion of patients with malignant cells in peritoneal lavage cytology

7. Molecular sub classification of gastric cancer (Time Frame - Pathology report 1/2 weeks after surgery):
DNA methylation arrays will be used to classify the gastric tumor into molecular subtypes

8. Protocol compliance to allocated treatment (Time Frame - Up to 5 years):
The proportion of patients who change from treatment arm

9. Hospital stay (Time Frame - Up to 5 year):
Defined as time interval between date of surgery and date of hospital discharge

10. Readmission rate (Time Frame - Within 30-days after surgery):
Rate of readmission

11. Reintervention rate (Time Frame - Within 30-days after surgery):
Rate of reintervention

12. Reoperation rate (Time Frame - Within 3 years after surgery):
Rate of reoperation

13. Quality of life assessment (Time Frame - At baseline, 3, 6, 9, 12 and 24 months):
Quality of life is assessed using the EuroQol-5 Dimension (EQ-5D-5L) descriptive system.

14. 3- & 5-year disease-free survival (Time Frame - After 3 years and 5 years post-operative):
Defined as the period of time from operation to locoregional recurrence, peritoneal recurrence, distant metastases, second gastric cancer or death from any cause. Patients alive and free of all these events will be censored at the last follow-up

15. Operative time (Time Frame - Intraoperative):
The surgical procedure duration in minutes, defined as time from first incision to last wound closure.

16. Cost-effectiveness (Time Frame - Up to 3 years post-operative):
Cost-effectiveness will be calculated by comparing the direct medical cost related to both strategies. The cost-effectiveness is compared by assessing cost per QALY.

Studien-Arme

  • Active Comparator: Complete omentectomy
    Gastrectomy with complete omentectomy
  • Experimental: Omentum presevation
    Gastrectomy with preservation of the omentum distal to the gastroepiploic vessels

Geprüfte Regime

  • Gastrectomy:
    Open or minimally invasive (sub)total gastrectomy

Quelle: ClinicalTrials.gov


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