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Neoadjuvant chemoradiotherapy plus surgery versus active surveillance for oesophageal cancer

Neoadjuvant chemoradiotherapy plus surgery versus active surveillance for oesophageal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25016
Enrollment
300
Registered
2017-11-08
Start date
2017-11-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Oesophageal cancer, oesofaguscarcinoom, esophageal cancer, active surveillance

Interventions

Approximately 4-6 weeks after completion of nCRT all patients will undergo a first clinical response evaluation (CRE-I) consisting of endoscopy with (random) bite-on-bite biopsies of the primary tumou

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Patients who are planned to undergo neoadjuvant chemoradiotherapy according to CROSS, followed by surgical resection for histologically proven oesophageal squamous cell carcinoma or adenocarcinoma of the oesophagus or oesophago-gastric junction, without distant dissemination; - Age =18; - Written, voluntary, informed consent.

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

MeasureTime frame
- Overal survivall

Secondary

MeasureTime frame
- Percentage of patients in active surveillance arm who do not undergo surgery (i.e. patients who are cured by neoadjuvant chemoradiotherapy or who have occult distant metastases during initial staging.

Contacts

Public ContactBerend Wilk, van der

Afdeling Heelkunde, Erasmus MC, Kamer Z-836

b.vanderwilk@erasmusmc.nl003107041223

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)