Clinical trial NCT03299270: Geriatric Oncology Surgical Assessment and Functional rEcovery After Surgery
Official title: GOSAFE Study Geriatric Oncology Surgical Assessment and Functional rEcovery After Surgery An International Prospective Audit to Evaluate Postoperative Functional Outcomes and Quality of Life After Cancer Surgery in Geriatric Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Elderly
Solid Malignancy
Keywords: Surgery
Solid malignancy
Elderly
Functional recovery
Lead sponsor: AUSL Romagna Rimini
Sponsor class: OTHER
Collaborators: name: European Society of Surgical Oncology
name: International Society of Geriatric Oncology
name: IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori)
First posted: 2017-10-03
Enrollment: 1004
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Centers should ensure that they would make every possible effort to include all consecutive eligible patients during the study period and provide completeness of data entry to ensure a 'real-life' study.

Brief summary: Multicenter, international, prospective, observational study, designed to evaluate the postoperative results in terms of quality of life and functional recovery of elderly patients after major cancer surgery.

The global expected duration of the study is 3 years, during which cancer patients over 70 years old undergoing major surgery will be evaluated before and after the surgical intervention, at 30 days, 3- and 6-months follow-up. The study is non-for-profit. Given the observational nature of the study, the original treatment plan, as designed by each individual recruiting centre, will not be altered or affected by the study inclusion. Inclusion in the study does not imply any deviation from the current standard of practice, and no change is expected to the perioperative treatment at any point. Patients will be only asked to complete simple screening/assessment tests.

Detailed description: GOSAFE study is a prospective international collaborative high-quality registry aiming to gain knowledge about postoperative outcomes in older cancer patients with a particular emphasis on QoL and FR. The target is to obtain meaningful data to assist clinicians in tailoring the care, avoiding under/over-treatment, providing robust data to identify new strategies to improve functional outcomes in older cancer patients.

Recruiting centers will collect data prospectively. Recruited patients will be followed for 6 months after their surgery.

The original treatment plan, as designed by each individual recruiting centre, will not be altered or affected by the study inclusion.

Centers should ensure that they would make every possible effort to include all consecutive eligible patients during the study period and provide completeness of data entry to ensure a 'real-life' study.

Patients both gender, both gender, aged ≥70, affected by solid malignancy undergoing elective major surgical procedures with curative or palliative intent are eligible.

Inclusion in the study does not imply any deviation from the current standard of practice, and no change is expected to the perioperative treatment at any point. Patients will be only asked to complete simple screening/assessment tests.

For every eligible patient, demographic data will be collected at baseline followed by a fast preoperative functional assessment. Data regarding surgical procedures and perioperative measures will be collected. Complications will be reported and graded according to Clavien-Dindo Classification. Three- and six-month follow up data will be collected after surgery within a range of 2 weeks from the due date.

The Full Analysis Set (FAS) consists of all registered patients. The primary endpoint will be measured for all registered subjects who fulfill preoperative and postoperative EQ VAS. Demographic and baseline patient characteristics will be summarized for all patients in the FAS. Continuous-scaled variables (e.g., age) will be summarized with means, medians, standard deviations, quartiles, and minimum and maximum values. Categorical variables (e.g., sex) will be summarized using patient counts and percentages. Study endpoints and variables will be evaluated using descriptive statistics, and the key figures of the distributions will be presented in tables. Univariate analyses will allow for a first overview of potentially influential factors.

Multiple linear regression models will be performed in order to evaluate predictors of functional recovery at 3 months and 6 months after surgery.

Exploratory subgroup analyses will be performed. Missing values will be replaced and estimated using multiple imputations. Furthermore, sensitivity analysis will be executed using complete-case analysis.

A sample size of 265 patients who completed pre and postoperative EQ VAS questionnaires will have a 90% power to detect an effect size of 0,2 between pre and post surgery ,using a paired t-test with a 0,05 two sided significance level.

Given a potential loss to follow-up (about 10%), uncompleted questionnaires (about 10%) and postoperative mortality (about 15%), the sample size will be increased to 350-400 patients (see ref 18 and 19).

Eligibility criteria: Inclusion Criteria:

1. All consecutive patients, both gender, aged ≥70
2. Patients affected by solid malignancy
3. Patients undergoing elective major surgical procedures with curative or palliative intent (all major procedures including any resection, for any cancer, via any operative approach, open, laparoscopic, robotic, etc...)
4. Informed consent obtainment

Exclusion Criteria:

1. Patients undergoing emergent/urgent surgical procedures
2. Planned hospital stay less than 48 hours

Primary outcomes:
measure: Quality of Life (QoL)
timeFrame: 6 months
Secondary outcomes:
measure: Functional recovery (FR)
timeFrame: 6 months
measure: Morbidity
timeFrame: 6 months
measure: Mortality
timeFrame: 6 months
measure: Prognostic factors
timeFrame: 6 months
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Philadelphia
country: United States
facility: University of Pennsylvenia Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Roger William Medical Centre
state: Rhode Island
city: Thessaloníki
country: Greece
facility: Medical School, Aristotle University of Thessaloniki
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Forlì
country: Italy
facility: Ospedale di Forlì
state: Forli-Cesena
city: Roma
country: Italy
facility: Ospedale S. Andrea
state: Lazio
city: Genova
country: Italy
facility: IRCCS Ospedale S. Martino Genova, Chirurgia Generale ad indirizzo oncologico
state: Liguria
city: Genova
country: Italy
facility: IRCCS Ospedale S. Martino Genova, Clinica Chirurgica 1
state: Liguria
city: Rozzano
country: Italy
facility: Humanitas
state: Milano
city: Desio
country: Italy
facility: Ospedale di Desio
state: Monza E Brianza
city: Spoleto
country: Italy
facility: Ospedale S. Matteo degli Infermi
state: Perugia
city: Bari
country: Italy
facility: IstitutoTumori Giovanni Paolo II
state: Puglia
city: Faenza
country: Italy
facility: General Surgery Unit
state: Ravenna
city: Riccione
country: Italy
facility: Ospedale di Riccione
state: Rimini
city: Milano
country: Italy
facility: Ospedale Niguarda
city: Piacenza
country: Italy
facility: Ospedale di Piacenza
city: Vercelli
country: Italy
facility: Clinica S. Rita
city: Groningen
country: Netherlands
facility: Groeningen University Hospital
city: Oslo
country: Norway
facility: Institute of clinical medicine
city: Kraków
country: Poland
facility: Jagiellonian University Medical College
city: Lisbon
country: Portugal
facility: General Surgery dept,Hospital Sao Francisco Xavier (CHLO)
city: Santiago do Cacém
country: Portugal
facility: Unidade Local de Saúde do Litoral Alentejano (ULSLA)
city: Alicante
country: Spain
facility: Universidad Miguel Hernández. Elche. Alicante
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
city: Liverpool
country: United Kingdom
facility: Dept. of Surgical Oncology - St. Helens Hospital of Liverpool
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary, University of Manchester
Study officials:
affiliation: AUSL Romagna
name: Giampaolo Giampaolo, MD
role: PRINCIPAL_INVESTIGATOR
References: