Chemotherapy Followed by Surgery versus Surgery Alone in Patients with Oesophageal Squamous Cell Carcinoma

Chemotherapy Followed by Surgery versus Surgery Alone in Patients with Oesophageal Squamous Cell Carcinoma: Long-term Results of a Randomised Controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN54829649

Enrollment

160

Registered

2010-10-25

Start date

1989-01-01

Completion date

Unknown

Last updated

2021-08-17

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

Conditions

Oesophageal squamous cell carcinoma Cancer Malignant neoplasm of oesophagus

Interventions

Random assignment was stratified by age, gender, weight loss in the past four months and length of the tumor as measured by esophago-gastroscopy. Patients assigned to preoperative chem

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed squamous cell carcinoma of the intra-thoracic oesophagus 2. No evidence of distant metastases 3. Absence of unresectable local disease 4. Below 80 years of age 5. In adequate physical condition (Karnofsky score >70) to undergo surgery 6. Adequate hepatic, renal and bone marrow function

Exclusion criteria

Exclusion criteria: 1. Synchronous cancer 2. Tumour localization in the cervical oesophagus (upper border, <18 cm from the incisor teeth) 3. Severe cardiovascular or pulmonary disease Patients with previous malignancies were eligible if more than 5 years had elapsed from diagnosis without evidence of tumor recurrence; exceptions were made for adequately treated basal cell cancer of the skin or carcinoma in situ of the cervix.

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Disease free survival	—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026