Feasibility of adjuvant treatment with S-1 and oxaliplatin in patients with resectable esophageal cancer

Completed

• Conditions: esophageal cancer; esophagus tumour; 10017991

• Registration Number: NL-OMON47475
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- Macroscopic radically resected adenocarcinoma of the esophagus
- Completed neoadjuvant treatment with paclitaxel 50 mg/m2 and carboplatin AUC
<= 2 on and radiotherapy to a total dose of 41.4 Gy in 23 fractions of 1.8 Gy, 5
fractions per week, with maximun one missed dose of systemic therapy, not due
to haematological toxicity
- Being able to start within 16 weeks after esophagectomy
- Age * 18 years
- WHO performance status 0-1
- Adequate bone marrow function (Hb * 6.0 mmol/L, absolute neutrophil count
*1.0 x 109/L, platelets * 100 x 109/L), renal function (serum creatinine * 1.5x
ULN and creatinine clearance, Cockroft formula, *30 ml/min), liver function
(serum bilirubin * 2 x ULN, serum transaminases * 3 x).
- Negative pregnancy test in women with childbearing potential.
- Expected adequacy of follow-up.
- Written informed consent.

Exclusion Criteria

- Any history or clinical signs of metastasis
- A second malignancy interfering with the prognosis of current esophageal
carcinoma
- Known dihydropyrimidine dehydrogenase (DPD) deficiency or treatment within 4
weeks with DPD inhibitors, including sorivudine or its chemically related
analogues such as brivudine.
- - Significant cardiovascular disease < 1 yr before start of the study (as
determined by the investigator, for example: symptomatic congestive heart
failure, myocardial ischemia or infarction, unstable angina pectoris, serious
uncontrolled cardiac arrhythmia, arterial thrombosis, cerebrovascular event,
significant pulmonary embolism).
- Chronic active infection.
- Any other concurrent severe or uncontrolled disease preventing the safe
administration of study drugs.
- Any impairment of gastrointestinal function or *disease that may
significantly impair the absorption of oral drugs (i.e. uncontrolled nausea,
vomiting, diarrhoea (defined as ³CTC grade 2), malabsorption syndrome, bowel
obstruction, or inability to swallow tablets).
- Concomitant treatments: concomitant (or within 4 weeks before randomisation)
administration of any other experimental drug under investigation; concurrent
treatment with any other anti-cancer therapy.
- Continuous use of systemic immunosuppressive agents (except the use of
corticosteroids as anti-emetic prophylaxis/treatment).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The percentage of patients completing the preplanned number of 6 cycles of<br /><br>SOX. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Percentage of patients completing 6 cycles of S-1 (with or without<br /><br>oxaliplatin)<br /><br>- Dose modifications (i.e. delays, dose reductions, or interruptions) for S-1<br /><br>- Dose modifications (i.e. delays, dose reductions, or interruptions) for<br /><br>oxaliplatin<br /><br>- Dose intensity of S-1.<br /><br>- Dose intensity of oxaliplatin<br /><br>- Toxicity<br /><br>- Disease free survival<br /><br>- Overall survival<br /><br><br /><br>Exploratory:<br /><br>- Assessment of pharmacokinetics of S1 in relation to safety and efficacy.<br /><br>- Potential biomarker development based on assessment of archived tumor tissue<br /><br>and blood samples and the proposed mechanism of action of study drugs.</p><br>