Accuracy of detecting residual disease after neoadjuvant chemoradiotherapy for oesophageal cancer (PRESANO trial)

Accuracy of detecting residual disease after neoadjuvant chemoradiotherapy for oesophageal cancer (PRESANO trial) - PRESANO trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43870

Enrollment

215

Registered

2013-06-18

Start date

2013-07-22

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

carcinoma of the oesophagus oesophageal cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Planned to undergo neoadjuvant chemoradiotherapy according to CROSS, followed by surgical resection for histologically proven oesophageal squamous cell carcinoma or adenocarcinoma - Age >= 18 - Written, voluntary informed consent

Exclusion criteria

Exclusion criteria: - Dementia or altered mental status prohibiting the understanding and giving of informed consent

Design outcomes

Primary

Measure	Time frame
Primary endpoint • Correlation between the clinical response during CRE-I and CRE-II (CRE= clinical response evaluation) and the final pathological response in the resection specimen as measured by the modified tumour regression grading system of Chirieac (Cancer 2005).	—

Secondary

Measure	Time frame
Secondary endpoints • Serious complications during endoscopic and endosonographic tissue sampling (conventional biopsies and FNA). • R0-resection rates for all included patients that undergo resection. Other important measurements that will be registered Further details per individual diagnostic modality will be registered and correlated with pathological findings in the resection specimen • Endoscopic examinations • Endoscopic ultrasonography (EUS) examinations • PET-CT • Analysis of (cyto)histological biopsies	—

Measure

Time frame

Secondary endpoints • Serious complications during endoscopic and endosonographic tissue sampling (conventional biopsies and FNA). • R0-resection rates for all included patients that undergo resection. Other important measurements that will be registered Further details per individual diagnostic modality will be registered and correlated with pathological findings in the resection specimen • Endoscopic examinations • Endoscopic ultrasonography (EUS) examinations • PET-CT • Analysis of (cyto)histological biopsies

—

Countries

Netherlands

Outcome results