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

Not Applicable

Recruiting

Conditions: C15
Malignant neoplasm of oesophagus

Registration Number: DRKS00032613

Lead Sponsor: niversitätsklinikum Schleswig-Holstein, Campus Lübeck

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 670

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

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 >50 Gy radiation dose

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoints (hierachically tested): <br>a)Overall survival (OS) time. <br>b)EORTC QLQ C30 global quality of life subscale.

Secondary Outcome Measures

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