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

NCT02564367 | Completed Phase 1

• 2 other identifiers: GMBH-STO-01142014-004116-11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 treatment regimen.

Conditions

Adenocarcinoma,Stomach; Adenocarcinoma, Esophagogastric Junction

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (5)

• One-year relapse-free survival rate

  12 months

• Relapse-free survival

  2 years

• Quality of life

  12 months

• One-year survival rate

  1 years

• Overall survival

  2 years

Other Outcomes (3)

• plasma concentration of Tegafur (FT)

  12 months

• plasma concentration of 5-Fluorouracil (5-FU)

  12 months

• plasma concentration of Gimeracil (CDHP)

  12 months

Study Arms (1)

Treatment

EXPERIMENTAL

First Cohort 1: (n = 30 patients) 18 cycles S-1

Drug: S-1

Interventions

S-1 DRUG

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

Also known as: Teysuno

Treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AIO-Studien-gGmbH: lead
• Nordic Pharma SAS: collaborator
• Taiho Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Klinikum der Universität München, Campus Großhadern

München, Bavaria, Germany

Location

MeSH Terms

Conditions

Adenocarcinoma

Interventions

S 1 (combination); tegafur-gimeracil-oteracil

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Volker Heinemann, Prof. Dr.

  Klinikum der Universität München, Campus Großhadern

  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: SPONSOR

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: September 30, 2015
• Study Start: October 6, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 6, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

DE (1)