NCT05953181

Brief Summary

An active surveillance approach is proposed after completion of neoadjuvant chemoradiotherapy (nCRT) for carcinoma of the oesophagus. In this SANO (i.e. Surgery As Needed for Oesophageal cancer) approach, surgical resection is offered only to patients in whom a locoregional regrowth is highly suspected or proven, without distant dissemination. Such an organ-preserving strategy can have great advantages, but is only justified if long-term survival is non-inferior to that of the current standard trimodality approach comprising neoadjuvant chemoradiotherapy followed by standard surgery. The aim of this study is to assess the (cost-)effectiveness (including non-financial costs and survival) of active surveillance for patients with squamous cell- or adenocarcinoma of the oesophagus or oesophago-gastric junction.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
776

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Nov 2017Jun 2026

Study Start

First participant enrolled

November 1, 2017

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

5.6 years

First QC Date

July 3, 2023

Last Update Submit

September 5, 2024

Conditions

Esophageal CancerActive SurveillanceNeoadjuvant ChemoradiotherapySurgical Oncology

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    the interval between the moment of achieving cCR (i.e. the moment the patient will start the intervention) and death or last follow-up, with a minimal follow-up of two years after reaching cCR.

Study Arms (2)

Active surveillance

EXPERIMENTAL
Procedure: Active surveillance

Standard esophagectomy

ACTIVE COMPARATOR
Procedure: Active surveillance

Interventions

Active surveillancePROCEDURE

Patients enrolled in the active surveillance arm will undergo diagnostic evaluations every 3 months in the first year after completion of neoadjuvant treatment, every 4 months in the second year, every 6 months in the third year and yearly in the 4th and 5th year of follow up, or when symptoms or results of any diagnostic test require shorter assessment intervals. In the active surveillance arm, surgical resection will be offered only to those patients, in whom a locoregional regrowth is highly suspected or proven, without any signs of distant dissemination.

Active surveillanceStandard esophagectomy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent or are planned to undergo neoadjuvant chemoradiotherapy according to CROSS and are planned to undergo potentially curative surgical resection for histologically proven oesophageal or junctional squamous cell carcinoma or adenocarcinoma are eligible. Whenever pathology is inconclusive but a multidisciplinary expert group concludes oesophageal carcinoma because of radiologically or endosonographically highly suspected lesions, patients are eligible for the study.
  • Age ≥18;
  • Written, voluntary, informed consent.

You may not qualify if:

  • Language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent and to complete quality of life questionnaires;
  • Non-FDG-avid tumour at baseline PET-CT scan;
  • Initial treatment with endoscopic resection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC, University Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 20, 2023

Study Start

November 1, 2017

Primary Completion

June 1, 2023

Study Completion (Estimated)

June 1, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

NL(1)