- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02564367
Feasibility Study of Adjuvant Treatment With S-1 in Patients After R0-Resection of Adenocarcinoma of the Stomach and Esophagogastric Junction (S-1 adjuvant)
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.
Study Overview
Status
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Bayern
-
München, Bayern, Germany
- Klinikum der Universität München, Campus Großhadern
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
First Cohort 1: (n = 30 patients) 18 cycles S-1 |
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of patients with discontinuation of S-1 due to intolerable adverse reactions
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 2 years
|
2 years
|
|
One-year relapse-free survival rate
Time Frame: 12 months
|
Mo local relapse or distant metastases within one year after start of adjuvant treatment
|
12 months
|
Relapse-free survival
Time Frame: 2 years
|
relapse-free survival until end of study
|
2 years
|
Quality of life
Time Frame: 12 months
|
European Organisation for Research and Treatment of Cancer (EORTC) C30 questionnaires
|
12 months
|
One-year survival rate
Time Frame: 1 years
|
1 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
plasma concentration of Tegafur (FT)
Time Frame: 12 months
|
To evaluate the pharmacokinetics of FT
|
12 months
|
plasma concentration of 5-Fluorouracil (5-FU)
Time Frame: 12 months
|
To evaluate the pharmacokinetics of 5-FU
|
12 months
|
plasma concentration of Gimeracil (CDHP)
Time Frame: 12 months
|
To evaluate the pharmacokinetics of CDHP
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Volker Heinemann, Prof. Dr., Klinikum der Universität München, Campus Großhadern
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GMBH-STO-0114
- 2014-004116-11 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adenocarcinoma,Stomach
-
Imugene LimitedActive, not recruitingStomach Cancer | Gastric Cancer | Gastric Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | Cancer of Stomach | Stomach AdenocarcinomaTaiwan, Australia
-
National Cancer Institute (NCI)CompletedStage IV Gastric Cancer | Recurrent Gastric Cancer | Stage III Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the StomachUnited States
-
Ukrainian Society of Clinical OncologyRecruitingStomach Cancer | Gastric Cancer | Gastric Adenocarcinoma | Gastrointestinal Cancer | Gastroesophageal Junction Adenocarcinoma | Advanced Gastric Adenocarcinoma | GastroEsophageal Cancer | Stomach Neoplasm | Gastric Neoplasm | Advanced Gastric Carcinoma | Advanced Gastroesophageal Junction AdenocarcinomaUkraine
-
Anwaar SaeedBristol-Myers Squibb; Clovis Oncology, Inc.RecruitingEsophagus Cancer, Adenocarcinoma | Stomach Cancer, AdenocarcinomaUnited States
-
National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
-
National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
-
National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
-
Jeeyun LeeRecruitingStomach Cancer, AdenocarcinomaKorea, Republic of
-
National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Adenocarcinoma of the Esophagus | Recurrent Esophageal Cancer | Stage IV Esophageal Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma...United States
Clinical Trials on S-1
-
Tomoshi TsuchiyaCompleted
-
Fudan UniversityThe First Affiliated Hospital of Anhui Medical University; Guangdong Provincial... and other collaboratorsWithdrawn
-
Sun Yat-sen UniversityUnknown
-
Peking University Cancer Hospital & InstituteRecruiting
-
Zhejiang Cancer HospitalCompleted
-
Taiho Oncology, Inc.Quintiles, Inc.; United BioSource, LLCCompletedAdvanced Non-Small Cell Lung Cancer
-
Hamamatsu UniversityUnknownGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Colon CancerJapan
-
Taiho Oncology, Inc.Quintiles, Inc.; United BioSource, LLCCompletedLocally Advanced or Metastatic Pancreatic Cancer
-
TTY BiopharmNational Taiwan University Hospital; Chang Gung Memorial Hospital; Taipei Veterans... and other collaboratorsTerminatedPancreatic Cancer | Adjuvant Chemotherapy | Resected Pancreatic CancerTaiwan
-
Fudan UniversityCompletedNasopharyngeal CarcinomaChina