AzTrials
AzTrials

Adenocarcinoma,StomachPhase 1/2S-1 adjuvantNCT02564367

Feasibility Study of Adjuvant Treatment With S-1 in Patients After R0-Resection of Adenocarcinoma of the Stomach and Esophagogastric Junction

A Phase 1/2 study testing S-1 in people with Adenocarcinoma,Stomach and Adenocarcinoma, Esophagogastric Junction, run by AIO-Studien-gGmbH at 1 site in Germany.

Completed

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

Official record
Search all trials

Trial summary

Multicenter trial in Germany: Feasibility Study of Adjuvant Treatment with S-1 in Patients after R0-Resection of Adenocarcinoma of the Stomach and Esophagogastric Junction with the aim to show the feasibility and tolerability of adjuvant S-1 treatment in Caucasian patients and to determine the recommended dose for the… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
S-1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteGermany
Study dates
6 Oct 2015to 6 Mar 2020
Phase
Phase 1/2
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

  • Patient signed and dated informed consent before the start of any specific protocol procedures
  • Adult Caucasian patients ≥ 18 years of age
  • Histologically confirmed diagnosis of adenocarcinoma of the stomach and esophagogastric (EG) junction classified as uT2/uT3/uT4, any N category, M0 or any uT, N+, M0 patient (for patients having received neoadjuvant chemotherapy) or pT2/pT3/pT4, any N category, M0 or any pT, N+, M0 (for patients having received primary surgery) according to Union international contre le cancer (UICC) TNM edition 7.
  • R0-resection after neoadjuvant treatment. However, patients can also be included if neoadjuvant treatment could not be performed due to medical indication of primary surgery (perforation, bleeding etc.) or was not performed due to understaging.
  • D2 lymph node dissection performed
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Show all 29Show fewer
  • Consent to translational research being performed on tumor tissue of the primary tumor that had been removed during the resection surgery. Translational research will be performed only upon completion of routine histological and pathological evaluations of the tumor
  • Females of childbearing potential (FCBP) must have a negative pregnancy test within 7 days of the first application of study treatment and must agree to use effective contraceptive birth control measures (Pearl Index < 1) during the course of the trial and for at least 6 months after last application of S-1.
  • Females of childbearing potential (FCBPs) should be included after a confirmed menstrual period (only if applicable, i.e. still having menses) and must have a negative highly sensitive pregnancy test within 7 days prior to the first application of study treatment and must agree to use highly effective contraceptive birth control measures (Pearl Index < 1) during the course of the trial and for at least 6 months after last application of S-1.
  • Such highly effective birth control methods include:
  • oral, intravaginal, or transdermal combined hormonal contraception associated with inhibition of ovulation
  • oral, injectable, or implantable progesterone-only hormonal contraception associated with inhibition of ovulation
  • intrauterine device
  • intrauterine hormone-releasing system
  • bilateral tubal occlusion
  • commitment to complete abstinence from heterosexual contact
  • A female subject following menarche is considered to be of childbearing potential unless she is naturally amenorrhoeic for ≥ 1 year without an alternative medical reason, or unless she is permanently sterile (permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy).
  • Males must agree not to father a child during the course of the trial and for at least 6 months after last administration of S-1 and must agree to use condoms during the course of the trial and for at least 6 months after last administration of S-1 in case of sexual intercourse with FCBP or pregnant female.
  • Patient must be able to take medication orally within eight weeks after surgery at the start of S-1.
  • Normal cardiac function demonstrated by Electrocardiogram (ECG) and echocardiogram (LVEF ≥ 55%)
  • Adequate bone marrow, hepatic and renal function defined as
  • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L
  • Haemoglobin ≥ 9 g/dL
  • Platelets ≥ 100 x 10^9/L
  • Albumin ≥ 2.5 g/dL
  • Total bilirubin ≤ 2 mg/dL
  • GOT/AST and GPT/ALT ≤ 3 x Upper normal limit (ULN)
  • Calculated creatinine clearance according to MDRD equation ≥ 50 mL/min
  • Patient's legal capacity to consent to study participation

Who cannot join

  • Metastatic disease (exclusion of metastatic disease by a postoperative CT or MRI scan of thorax and abdomen within 3 weeks prior to start of adjuvant therapy)
  • Polyneuropathy > grade 1 (NCI CTCAE version 4.0)
  • Evidence of ascites or liver cirrhosis
  • Patient is pregnant or breast-feeding
  • Patient underwent a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment, or there is an anticipated need for major surgical procedure during the course of the study.
  • Heart failure ≥ NYHA functional classification system grade 2
Show all 20Show fewer
  • Myocardial infarction, unstable angina, cardiac angioplasty or stenting procedure within the last 6 months.
  • Medical history of pulmonary fibrosis or interstitial lung disease (ILD)
  • Active or uncontrolled bacterial, viral, or fungal infection that requires systemic treatment
  • Known HIV-, HBV-, and HCV-infection
  • Concurrent disease or condition that would make the patient inappropriate for study participation or would interfere with the patient's safety.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  • Any cancer therapy (chemotherapy, radiation therapy, biologic therapy, immunotherapy, or hormonal therapy) after resection surgery or requirement for concurrent cancer treatment during study treatment with S-1.
  • Participation in another clinical trial or treatment with an investigational drug after surgery and during study treatment with S-1.
  • Known immediate or delayed hypersensitivity to any of the active substances of S-1 (tegafur, gimeracil, and oteracil) or to any of the excipients or to drugs chemically related to S-1 (e.g. 5-fluorouracil)
  • History of severe and unexpected reactions to fluoropyrimidine therapy
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Treatment with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine within 4 weeks before start of study drug or during study treatment
  • Previous or concurrent malignant tumor disease other than underlying tumor disease with the exception of cervical cancer in situ, adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder tumors (Ta, Tis, and T1) or any curatively treated tumors > 5 years prior to enrolment
  • Known alcohol abuse or drug addiction

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinikum der Universität München, Campus Großhadern

    München, Bavaria

Other trials in Germany

About this study

Official title: Multicenter Phase I/II Feasibility Study of Adjuvant Treatment With S-1 in Patients After R0-Resection of Adenocarcinoma of the Stomach and Esophagogastric Junction

Multicenter trial in Germany:

Feasibility Study of Adjuvant Treatment with S-1 in Patients after R0-Resection of Adenocarcinoma of the Stomach and Esophagogastric Junction with the aim to show the feasibility and tolerability of adjuvant S-1 treatment in Caucasian patients and to determine the recommended dose for the treatment regimen.

Read the detailed description

Patients will be enrolled in one cohorts.

Cohort 1 consists of 30 patients who receive S-1 twice daily for 18 cycles (D1-14 q 3 wks).

Being tested
S-1
Medical subject headings
Adenocarcinoma

What participants receive

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

  • S-1Drug

    Also called Teysuno

    18 cycles S-1, orally administered twice daily D1-14, q 3 wks

    S-1 starting dose: 2 x 30 mg/m^2 body surface area (BSA), D1-14, q 3 wks First dose reduction: 2 x 25 mg/m^2 BSA, D1-14, q 3 wks Second dose reduction: 2 x 20 mg/m^2 BSA, D1-14, q 3 wks

Study groups in NCT02564367
Study groupRoleWhat they receive
TreatmentExperimentalFirst Cohort 1: (n = 30 patients) 18 cycles S-1
Receives: Drug: S-1

What is being measured

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

  1. number of patients with discontinuation of S-1 due to intolerable adverse reactions

    Measured: 12 months

Secondary outcomes (5)

  1. One-year relapse-free survival rate

    Mo local relapse or distant metastases within one year after start of adjuvant treatment

    Measured: 12 months

  2. Relapse-free survival

    relapse-free survival until end of study

    Measured: 2 years

  3. Quality of life

    European Organisation for Research and Treatment of Cancer (EORTC) C30 questionnaires

    Measured: 12 months

  4. One-year survival rate

    Measured: 1 years

  5. Overall survival

    Measured: 2 years

Timeline

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

  1. First posted30 Sep 2015 (estimated)
  2. Study start6 Oct 2015
  3. Primary completion1 Mar 2019
  4. Study completion6 Mar 2020

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02564367
Sponsor's protocol ID
GMBH-STO-0114
Other IDs
2014-004116-11, 2014
Acronym
S-1 adjuvant
Status last verified
Apr 2021
First submitted
10 Apr 2015
Last updated
29 Apr 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing S-1 in people with Adenocarcinoma,Stomach and Adenocarcinoma, Esophagogastric Junction, run by AIO-Studien-gGmbH at 1 site in Germany.

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 29 inclusion and 20 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 29 Apr 2021. 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 Germany. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

number of patients with discontinuation of S-1 due to intolerable adverse reactions (time frame: 12 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 NCT02564367.

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 29 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in