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Esophageal CancerPhase 1SOXNCT02347904

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

A Phase 1 study testing S-1 and Oxaliplatin in people with Esophageal Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer
What is being tested?
S-1 and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteNetherlands
Study dates
Dec 2014to Nov 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Academic Medical Center, Medical Oncology

    Amsterdam, 1100 DD

Other trials in Netherlands

About this study

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.

Read the detailed description

Since the outcome of patients with esophageal cancer treated with neoadjuvant chemoradiation and surgery is still poor, strategies to improve survival should be explored. The benefit of adjuvant chemotherapy after neoadjuvant chemoradiotherapy followed by surgery is unknown. Preferably, such adjuvant chemotherapy regimen should consist of a non-cross resistant, well-tolerated schedule. For this purpose, the combination of S-1, an oral fluoropyrimidine, with oxaliplatin, may be of benefit, as each of these compounds have shown efficacy in gastroesophageal cancer. Also, importantly, the combination of S-1 with oxaliplatin (SOX) in advanced gastric cancer was well-tolerated. Nevertheless, it should be acknowledged that after major surgery for esophageal cancer, adjuvant treatment with combination chemotherapy may be hard to accomplish as was shown in the MAGIC trial for gastric cancer where less than half of all patients completed adjuvant therapy.

Therefore the investigators want to assess the feasibility of an adjuvant treatment scheme with S-1 and Oxaliplatin. When the proposed treatment scheme is feasible the potential benefit on survival will be evaluated in further studies. Feasibility is defined ≥50% of patients completing the pre-planned number of cycles

Study Objectives Primary Objective To assess the feasibility of administering adjuvant SOX in patients with esophageal cancer after neoadjuvant chemoradiotherapy with paclitaxel and carboplatin and esophagectomy

Secondary Objectives

  1. Percentage of patients completing 6 cycles of S-1 (with or without oxaliplatin).
  2. Dose modifications (ie, delays, dose reductions, or interruptions) for S-1.
  3. Dose modifications (ie, delays, dose reductions, or interruptions) for oxaliplatin.
  4. Dose intensity of S-1.
  5. Dose intensity of oxaliplatin.
  6. Toxicity.
  7. Disease free survival.

Exploratory Objectives

  1. Assessment of pharmacokinetics of S1 as predictive factors for efficacy and toxicity.
  2. Potential biomarker development based on assessment of archived tumor tissue and blood samples and the proposed mechanism of action of study drugs.
Being tested
S-1 and Oxaliplatin
Keywords
Esophageal cancer, Adjuvant treatment, S-1, Oxaliplatin, Feasibility
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S-1 and OxaliplatinDrug

    Also called Teysuno

    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

Study groups in NCT02347904
Study groupRoleWhat they receive
Adjuvant S-1 and OxaliplatinExperimentalAdjuvant treatment with s-1 and oxaliplatin after neoadjuvant chemoradiation and esophagectomy in patients with resectable esophageal cancer
Receives: Drug: S-1 and Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 24 months

Secondary outcomes (12)

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

    Measured: 24 months

  2. Dose modifications for S-1

    in terms of delay of treatment in weeks

    Measured: 24 months

  3. Dose modifications for S-1

    in terms of dose reduction in percentage of orginal dose

    Measured: 24 months

  4. Dose modifications for S-1

    in terms of number of interruptions of treatment

    Measured: 24 months

  5. Dose modifications for Oxaliplatin

    in terms of delay of treatment in weeks

    Measured: 24 months

  6. Dose modifications for Oxaliplatin

    in terms of dose reduction in percentage of orginal dose

    Measured: 24 months

  7. Dose modifications for Oxaliplatin

    in terms of number of interruptions of treatment

    Measured: 24 months

  8. Dose intensity for S-1

    total received dose of S-1 in mg/m2 per week

    Measured: 24 months

  9. Dose intensity for Oxaliplatin

    total received dose of oxaliplatin in mg/m2 per week

    Measured: 24 months

  10. Toxicity

    in terms of CTCAE v4.0 criteria

    Measured: 24 months

  11. Disease free survival

    in months

    Measured: 24 months

  12. Overall survival

    in months

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionNov 2019
  4. Study completionNov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02347904
Sponsor's protocol ID
NL49889.018.14
Acronym
SOX
Status last verified
Nov 2019
First submitted
16 Dec 2014
Last updated
18 Nov 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing S-1 and Oxaliplatin in people with Esophageal Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage of patients completing the preplanned number of 6 cycles of SOX. (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02347904.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.

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