Survival and Patterns of Care in the Era of Fluorouracil, Leucovorin, Oxaliplatin and Docetaxel (FLOT)-based Chemotherapy for Gastric and Gastroesophageal Adenocarcinoma (SPACE-FLOT): An international multicentre cohort study

Survival and Patterns of Care in the Era of FLOT-based Chemotherapy for Gastric and Gastroesophageal Adenocarcinoma (SPACE-FLOT): An international multicentre cohort study

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12622000180718

Acronym

SPACE-FLOT

Enrollment

1575

Registered

2022-02-02

Start date

2022-03-01

Completion date

2022-09-01

Last updated

2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Gastric and gastroesophageal cancers are common and carry exceedingly high mortality rates. Of those patients treated with curative intent, the majority have locally advanced disease, and require chemotherapy before and after radical surgery. Since 2017, 5-fluorouracil, leucovorin, oxaliplatin and paclitaxel (FLOT)-based chemotherapy has become the most commonly used perioperative regimen. This study aims to assess the survival patterns of patients receiving this chemotherapy regimen, and to assess whether receiving FLOT-based chemotherapy both before and after surgical management affects survival compared to those who received only pre-operative FLOT-based chemotherapy. Who is it for? You may be eligible for this study if you are aged 18 years and over, have been diagnosed with gastric or gastroesophageal cancer, and received preoperative FLOT-based chemotherapy and surgical resection between 01/01/2017 to 31/12/2021. Study details For all participants, information regarding survival and disease progression (identified clinically, biochemically, and/or radiologically) will be obtained from your electronic medical record, with no study visits or additional testing required. This data will be used to compare the survival and disease progression between those who did and did not receive post-operative FLOT-based chemotherapy. It is hoped that this research may identify whether there is any further survival benefit from providing post-operative FLOT-based chemotherapy, which may help to dictate future management of patients with gastric or gastroesophageal cancer.

Interventions

To audit the patterns of care and survival outcomes of patients with gastric and gastroesophageal adenocarcinoma who have undergone preoperative FLOT-based chemotherapy and radical surgical resection stratified by pathological response in the resected specimen. This study is an international (Australia, New Zealand, Singapore, Malaysia, Hong Kong, Vietnam, India, England, Ireland, Sweden, The Netherlands, France, and Canada) retrospective analysis of practice and outcomes between January 1 2017 to Dec 31 2022. Follow-up data collection is out to Dec 31, 2022 as we need a minimum one-year survival data. We aim to collect data for at least 1500 consecutive patients from all participating sites. Patient data will include: • Patient demographics, co-morbidities and characteristics • Treatment history including pre-operative, operative, and post-operative interventions • Post-operative complications within 30 days post-surgery • Clinicopathological and molecular features of disease • Disease outcomes and survival • Follow-up data until 2 years post-surgery All data collected from medical records (no active participant involvement)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• Any patient with gastric and gastroesophageal cancer • Received preoperative FLOT-based chemotherapy and surgical resection between 01/01/2017 to 31/12/2021 • Age less than or equal to 18 years-of-age

Exclusion criteria

• Received further neoadjuvant therapy in addition to FLOT chemotherapy • Stage 4 disease at diagnosis • Death within 30 days post resection

Outcome results