Surgery as needed versus surgery on principle in patients with postneoadjuvant clinical complete tumor response of esophageal cancer

Surgery as needed versus surgery on principle in patients with postneoadjuvant clinical complete tumor response of esophageal cancer - ESORES-Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00032613

Enrollment

670

Registered

2023-09-27

Start date

2024-01-30

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

C15

Interventions

Group 1: Experimental intervention: Arm A consists of clinical response evaluation (CRE) including esophagogastroscopy, endoscopic deep biopsies of the tumor area, endoscopic ultrasound (EUS) plus fi

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Key inclusion criteria: • EC (adenocarcinoma (EAC) and squamous cell carcinoma (ESCC)) according to the UICC definition (TNM8), • TNM stage: ycT0-3 ycN0 ycM0, • completion of neoadjuvant chemotherapy or neoadjuvant chemoradiation • no visible lymphatic or distant metastasis in routine postneoadjuvant CT, • ECOG Performance status 0-2 • Age = 18 years

Exclusion criteria

Exclusion criteria: Key exclusion criteria: • Postneoadjuvant dysphagia • Tumors of the cervical esophagus • Tumors with direct proximity to the membranous part of the central airway • TNM stage cT4 or ycT4 • TNM stage cM1 or ycM1 • Postneoadjuvant esophageal obstruction • Local tumor progression during/after neoadjuvant therapy detected by endoscopy or cross-sectional imaging • Time since last day of neoadjuvant anti-cancer treatment = 9 weeks • Co-morbidity with contraindication for major surgery • nCRT with >51 Gy radiation dose

Design outcomes

Primary

Measure	Time frame
Primary endpoints (hierachically tested): a)Overall survival (OS) time. b)EORTC QLQ C30 global quality of life subscale.	—

Secondary

Measure	Time frame
Secondary endpoints: Efficacy: • long term tumor control: o disease free survival (DFS) time, o time to distant metastasis (TDM), o time to local recurrence, o time to regional recurrence. • quality of life: o EORTC QLQ C30, o EORTC QLQ OES18. o fear of progression (FoP-Q-12), o surgery-free survival (SFS) time in arm A, o patients’ satisfaction, • economic impact: o days of hospitalization, o hospitalization costs. Safety: • Interventional Safety: perioperative complications and periinterventional complications summarized by the 3-Year-Comprehensive Complication Index (3-Year-CCI) • Oncological Safety: o diagnostic accuracy of CRE in arm A o resection status (R0/R1/R2) o irresectable regrowth during active surveillance in arm A	—

Measure

Time frame

Secondary endpoints: Efficacy: • long term tumor control: o disease free survival (DFS) time, o time to distant metastasis (TDM), o time to local recurrence, o time to regional recurrence. • quality of life: o EORTC QLQ C30, o EORTC QLQ OES18. o fear of progression (FoP-Q-12), o surgery-free survival (SFS) time in arm A, o patients’ satisfaction, • economic impact: o days of hospitalization, o hospitalization costs. Safety: • Interventional Safety: perioperative complications and periinterventional complications summarized by the 3-Year-Comprehensive Complication Index (3-Year-CCI) • Oncological Safety: o diagnostic accuracy of CRE in arm A o resection status (R0/R1/R2) o irresectable regrowth during active surveillance in arm A

—

Countries

Germany

Contacts

Public ContactJens Höppner

Universitätsklinikum OWL der Universität Bielefeld, Campus Lippe

esores@uni-bielefeld.de0049 5231 722251

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026