Clinical trial to identify biomarkers to select patients with esophageal cancer for oxaliplatin and 5-fluorouracil chemotherapy prior to surgery

Phase II trial of neo-adjuvant Oxaliplatin and 5-fluorouracil in esophageal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18146225

Enrollment

Registered

2017-10-12

Start date

2006-05-01

Completion date

Unknown

Last updated

2018-08-27

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

Conditions

Esophageal cancer Cancer Malignant neoplasm of oesophagus

Interventions

All patients received Oxaliplatin 130 mg/m2 IV on day 1, followed by 5FU 1gm/m2 per day on days 1-4. Two cycles given 3 weeks apart. Follow-up was for 6 months after the last cycle of chemotherapy.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically proven operable oesophageal adenocarcinoma/squamous cell carcinoma 2. Age greater than or equal to 18 years 3. Suitable for neo-adjuvant chemotherapy according to local protocols 4. Subjects must be free of any clinically significant disease other than oesophageal cancer that would interfere with the study evaluations 5. Adequate haematologic, renal and hepatic function as demonstrated by laboratory values performed within 14 days prior to the administration of chemotherapy: 5.1. Absolute neutrophil count (ANC) = 1500/mm3 5.2. Platelet count = 100,000/ mm3 5.3. Haemoglobin = 10g/dL 5.4. Urea and serum creatinine < 1.5 times upper limit of laboratory normal (ULN) 5.5. Creatinine clearance: more than 50ml (by Cockcroft Gault calc) 5.6. Total bilirubin < 1.5 times ULN 5.7. AST = 3 times ULN 5.8. Alkaline phosphatase < 2 times ULN 6. Patients must have given written informed consent 7. Women of child-bearing potential must use an acceptable method of birth control during the study

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant or nursing (pregnancy test to be performed within 24 hours prior to starting the study drug(s)) 2. Known dihydropyrimidine dehydrogenase deficiency 3. Subjects known to be HIV, Hep B or Hep C positive

Design outcomes

Primary

Measure	Time frame
1. DNA repair gene expression in tumour tissue, measured using microarray at baseline and 4-6 weeks after the last dose of chemotherapy. 2. Clinical outcomes, measured using disease-free survival and overall survival at 6-12 months post chemotherapy	—

Secondary

Measure	Time frame
Haplotype and DNA repair gene pathways measured using immunohistochemistry at baseline and 4-6 weeks after the last dose of chemotherapy	—

Countries

United Kingdom

Outcome results

None listed

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