Feasibility Study of Adjuvant Treatment With S-1 and Oxaliplatin in Patients With Resectable Esophageal Cancer

NCT02347904 | Completed Phase 1 DMC

• 1 other identifier: NL49889.018.14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective single arm study the investigators will assess the feasibility of S-1 and Oxaliplatin as adjuvant treatment in patients with esophageal cancer. The primary objective is to assess the feasibility of administering adjuvant S-1 and Oxaliplatin (SOX) in patients with esophageal cancer after neoadjuvant chemoradiotherapy with paclitaxel and carboplatin and esophagectomy. Primary end point is the percentage of patients completing the preplanned number of 6 cycles of SOX.

Conditions

Esophageal Cancer

Keywords

Esophageal cancer; Adjuvant treatment; S-1; Oxaliplatin; Feasibility

Outcome Measures

Primary Outcomes (1)

• The percentage of patients completing the preplanned number of 6 cycles of SOX.

  24 months

Secondary Outcomes (12)

• Percentage of patients completing 6 cycles of S-1 (with or without oxaliplatin)

  24 months

• Dose modifications for S-1

  24 months

• Dose modifications for S-1

  24 months

• Dose modifications for S-1

  24 months

• Dose modifications for Oxaliplatin

  24 months

Other Outcomes (1)

• AUC of S-1

  24 months

Study Arms (1)

Adjuvant S-1 and Oxaliplatin

EXPERIMENTAL

Adjuvant treatment with s-1 and oxaliplatin after neoadjuvant chemoradiation and esophagectomy in patients with resectable esophageal cancer

Drug: S-1 and Oxaliplatin

Interventions

S-1 and Oxaliplatin DRUG

Six courses of oxaliplatin (130 mg/m2) intravenously on day 1 and S-1 (25 mg/m2 b.i.d.) orally from day 1 to 14 every 3 weeks, starting within 12 weeks after esophagectomy

Also known as: Teysuno

Adjuvant S-1 and Oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radically resected adenocarcinoma of the esophagus
• Completed neoadjuvant treatment with paclitaxel 50 mg/m2 and carboplatin Area Under Curve (AUC) = 2 on days 1, 8, 15, 22 and 29 and radiotherapy to a total dose of 41.4 Gy in 23 fractions of 1.8 Gy, 5 fractions per week.
• 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 Upper Limit Normal (ULN), serum transaminases ≤ 3 x).
• Negative pregnancy test in women with childbearing potential.
• Expected adequacy of follow-up.
• Written informed consent.

You may not qualify if:

• Any history or clinical signs of metastasis
• History of a second malignancy \<5 years with the exception of adequately treated carcinoma of cervix or basal/squamous cell carcinoma of skin.
• 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 (symptomatic congestive heart failure, myocardial ischemia or infarction, unstable angina pectoris, serious uncontrolled cardiac arrhythmia, arterial thrombosis, cerebrovascular event, 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 CTC grade 2 or higher), malabsorption syndrome, bowel obstruction, or inability to swallow tablets).
• Concomitant treatments: concomitant (or within 4 weeks before start of the study) 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).

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Celgene Corporation: collaborator

Study Sites (1)

Academic Medical Center, Medical Oncology

Amsterdam, 1100 DD, Netherlands

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

S 1 (combination); Oxaliplatin; tegafur-gimeracil-oteracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• H WM van Laarhoven, MD,PHD,PHD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. H.W.M. van Laarhoven

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: January 28, 2015
• Study Start: December 1, 2014
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

NL (1)