Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal JunctionPhase 2MATEONCT02128243
Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer
A Phase 2 study testing S-1 de-escalation and Chemotherapy by Investigator's choice in people with Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction and Gastric Neoplasm, run by AIO-Studien-gGmbH at 1 site in Germany.
Trial summary
The aim is to assess the relative efficacy of S-1 de-escalation therapy vs. continuation of chemotherapy after induction therapy in patients with metastatic esophagogastric cancer in terms of overall survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction, Gastric Neoplasm, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- S-1 de-escalation and Chemotherapy by Investigator's choice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to 8 Oct 2020
- Phase
- Phase 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
- Signed written informed consent incl. participation in translational research
- Male or female patient 18 years or older
- Histologically confirmed metastatic or locally advanced unresectable gastric adenocarcinoma or adenocarcinoma of the esophagus or the esophagogastric junction (Her-2/neu negative or with unknown Her-2/neu status)
- Adjuvant/neoadjuvant or perioperative chemotherapy or (chemo-)radiotherapy must have been finished at least 6 months before start of the induction therapy
- For patients enrolled before induction therapy: No previous systemic treatment (i.e. chemotherapy) for metastatic disease
- For patients enrolled after induction therapy: Having finished a three-months induction therapy (6 cycles of a bi-weekly regimen, 4 cycles of a three-weekly regimens or 3 cycles of a four-weekly regimen) without tumor progression or limiting toxicity
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- ECOG Performance Score 0-1 (Karnofsky Performance status >= 80%)
- Ability for oral intake of the study drug, patients with tumor-related problems with oral intake might be registered if the symptom is expected to be improved during induction therapy (e.g. due to a tumor stenosis)
- Female patient of childbearing potential (i.e. did not undergo surgical sterilization - hysterectomy, bilateral tubal ligation, or bilateral oophorectomy - and is not post-menopausal for at least 24 consecutive months) with a negative pregnancy test
- Hematology and biochemistry laboratory results within the limits normally expected for the patient population, defined by the following:
- Absolute neutrophil count ≥ 1500/µl
- Platelet count ≥ 100000/µl
- Leukocyte count > 3000/µl
- Hemoglobin ≥ 9 g/dL or 5.59 mmol/l, previous transfusions (>3 days) of erythrocytes are allowed
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), in patients with known Meulengracht syndrom ≤3 x ULN
- AST ≤ 3xULN in absence of liver metastases, or ≤5xULN in presence of liver metastases
- ALT ≤ 3xULN in absence of liver metastases, or ≤5xULN in presence of liver metastases
- Creatinine clearance ≥30 mL/min according to Cockcroft-Gault formula
Who cannot join
- Previous major sugery within the last 28 days before the start of the induction treatment. The implantation of a central venous access (e.g. porth-a cath system) is allowed.
- History of other malignant tumors within the last 5 years before start of induction treatment, except basal cell carcinoma or curatively excised cervical carcinoma in situ
- Known brain metastases
- Concurrent radiotherapy involving target lesions used for this study. Concurrent palliative radiation for non-target lesions is allowed if other target lesions are available outside the involved field; previous radiotherapy including target lesions must have been finished at least 28 days before start of induction treatment.
- For patients enrolled before the induction therapy: Previous systemic treatment (i.e. chemotherapy) for metastatic disease
- Known active HBV, HCV infection or documented HIV infection
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- Serious concomitant disease or medical condition that by judgment of the Investigator renders the patient at high risk of treatment complications
- Clinically relevant coronary artery disease (NYHA functional angina classification III/IV), congestive heart failure (NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the last 3 months, or high risk of uncontrolled arrhythmia
- Female patient pregnant or breast feeding
- Female patient of childbearing potential (i.e. did not undergo surgical sterilization - hysterectomy, bilateral tubal ligation, or bilateral oophorectomy - and is not post-menopausal for at least 24 consecutive months) not willing to use an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the end of treatment. Male patient not willing to use an adequate method of contraception to avoid conception throughout the study and for up to 26 weeks after the end of treatment in such a manner that the risk of pregnancy is minimized.
- Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 60 days prior to start of induction (e.g. one of the allowed standard chemotherapies (see above) with or without additional placebo within a clinical trial is allowed)
- Chronic diarrhea or short bowel syndrome
- Known hypersensitivity to S-1, other fluoropyrimidines or platinum compounds. Contraindication to receive S-1 or the polychemotherapy (induction \& arm B) chosen for this patient as per current Summary of Product Characteristics. Known DPD deficiency
- For patients enrolled before the induction therapy: Grade ≥2 peripheral neuropathy
- Known drug abuse/alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer
The aim is to assess the relative efficacy of S-1 de-escalation therapy vs. continuation of chemotherapy after induction therapy in patients with metastatic esophagogastric cancer in terms of overall survival.
Read the detailed description
Open-label, multi-center, controlled, randomized, parallel-group phase II trial in patients with metastatic esophagogastric cancer having received induction chemotherapy.
Patients will be registered before or after application of a three-months induction chemotherapy . This 12-week induction therapy will consist of one of the following regimens: FLO/mod. Folfox-6, Cisplatin/5-FU, Cisplatin/S-1, FLOT, EOX/EOF or XP. Regarding dose adjustments, Investigators should refer to Section 6.3 and to the summary of product characteristics of the chemotherapeutical agents. Patients having finished the preplanned induction therapy without tumor progression (i.e. with complete remission (CR), partial remission (PR), stable disease (SD) or non-CR/non-PD in patients with non-measurable disease only according to RECIST Criteria Version 1.1) at week 12, being able to swallow capsules and having Eastern Cooperative Oncology Group (ECOG) performance score of 0-1 will be randomized in a 2:1 ratio to receive Arm A or B.
In Arm A patients will continue with S-1 de-escalation phase starting at week 13 until disease progression, toxicities requiring discontinuation, withdrawal of consent, pregnancy, death or lost to follow up whichever occurs first. In patients with drug-related severe toxicity S-1 dose will be adjusted or study treatment will be terminated.
In Arm B patients will continue to receive the same polychemotherapy as during induction therapy until tumor progression, toxicities requiring discontinuation, withdrawal of consent, pregnancy, death or loss to follow up whichever occurs first.
- Conditions
- Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction, Gastric Neoplasm, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma, Gastric Adenocarcinoma, Esophageal Neoplasms
- Being tested
- S-1 de-escalation, Chemotherapy by Investigator's choice
- Medical subject headings
- Neoplasm Metastasis, Stomach Neoplasms, Adenocarcinoma Of Esophagus, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1 de-escalationDrug
Also called Teysuno
S-1 30 mg/m² bid d1-14 q21d
Chemotherapy by Investigator's choiceDrug
Also called FLO regimen, - Oxaliplatin 85 mg/m², - Leucovorin 200 mg/m², - 5-Fluorouracil 2600 mg/m²
Polychemotherapy administration as in induction therapy consists of a platinum and fluoropyrimidine compound as well as optional a taxane / an anthracycline compound.
Two-Drug combinations:
FLO / mod. FOLFOX-6; Cisplatin, S-1; Cisplatin, 5-FU; Cisplatin, Capecitabine (XP)
Three-drug combinations:
EOX/EOF FLOT
| Study group | Role | What they receive |
|---|---|---|
| Arm A: De-escalation therapy | Experimental | Patients in Arm A will continue with S-1 de-escalation phase starting at week 13 until disease progression, toxicities requiring discontinuation, withdrawal of consent, pregnancy, death or lost to follow up whichever occurs first. In patients with drug-related severe toxicity S-1 dose will be adjusted or study treatment will be terminated. Receives: Drug: S-1 de-escalation |
| Arm B: Chemotherapy by Investigator's choice | Experimental | Patients in Arm B will continue to receive the same polychemotherapy as during induction therapy until tumor progression, toxicities requiring discontinuation, withdrawal of consent, pregnancy, death or loss to follow up whichever occurs first. Receives: Drug: Chemotherapy by Investigator's choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS will be defined as the time length between randomization and the date of death from any cause or the date of last follow-up in case of no documentation of death.
Measured: approx. 12 month
Secondary outcomes (2)
Progression-free survival (PFS)
PFS will be defined as the time length between the date of randomization and the date of first disease progression or death (whichever occurs first).
Measured: approx. 12 month
Quality of Life
Quality of life will be evaluated using the validated European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 questionnaire and the gastric module STO22.
Measured: approx. 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startSep 2014
- Primary completion8 Oct 2020
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal JunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIO-Studien-gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Taiho Pharmaceutical Co., Ltd., Nordic Pharma SAS
- Responsible party
- Sponsor
- Investigators
- Georg Martin Haag, Dr., Principal investigator, NCT-Med. Onkologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128243
- Sponsor's protocol ID
- AIO-YMO-0111
- Other IDs
- 2013-002742-37
- Acronym
- MATEO
- Status last verified
- Mar 2021
- First submitted
- 29 Apr 2014
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Stocker G, Lorenzen S, Ettrich T, Herz AL, Longo F, Kiani A, Venerito M, Trojan J, Mahlberg R, Moosmann N, Chibaudel B, Kubicka S, Greil R, Daum S, Geissler M, Larcher-Senn J, Keller G, Lordick F, Haag GM. S-1 maintenance therapy in Caucasian patients with metastatic esophagogastric adenocarcinoma-final results of the randomized AIO MATEO phase II trial. ESMO Open. 2023 Jun;8(3):101572. doi: 10.1016/j.esmoop.2023.101572. Epub 2023 Jun 2.
PubMed 37270871Haag GM, Stocker G, Quidde J, Jaeger D, Lordick F. Randomized controlled trial of S-1 maintenance therapy in metastatic esophagogastric cancer - the multinational MATEO study. BMC Cancer. 2017 Jul 31;17(1):509. doi: 10.1186/s12885-017-3497-9.
PubMed 28760152
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer
- ClinicalTrials.gov ID
- NCT02128243
- Acronym / sponsor ID
- MATEO / AIO-YMO-0111
- Conditions
- Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction, Gastric Neoplasm, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma, Gastric Adenocarcinoma, Esophageal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- AIO-Studien-gGmbHUniversity, hospital or other
- Collaborators
- Taiho Pharmaceutical Co., Ltd., Nordic Pharma SAS
- Study start
- Sep 2014
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to assess the relative efficacy of S-1 de-escalation therapy vs. continuation of chemotherapy after induction therapy in patients with metastatic esophagogastric cancer in terms of overall survival.
Detailed description
Open-label, multi-center, controlled, randomized, parallel-group phase II trial in patients with metastatic esophagogastric cancer having received induction chemotherapy.
Patients will be registered before or after application of a three-months induction chemotherapy . This 12-week induction therapy will consist of one of the following regimens: FLO/mod. Folfox-6, Cisplatin/5-FU, Cisplatin/S-1, FLOT, EOX/EOF or XP. Regarding dose adjustments, Investigators should refer to Section 6.3 and to the summary of product characteristics of the chemotherapeutical agents. Patients having finished the preplanned induction therapy without tumor progression (i.e. with complete remission (CR), partial remission (PR), stable disease (SD) or non-CR/non-PD in patients with non-measurable disease only according to RECIST Criteria Version 1.1) at week 12, being able to swallow capsules and having Eastern Cooperative Oncology Group (ECOG) performance score of 0-1 will be randomized in a 2:1 ratio to receive Arm A or B.
In Arm A patients will continue with S-1 de-escalation phase starting at week 13 until disease progression, toxicities requiring discontinuation, withdrawal of consent, pregnancy, death or lost to follow up whichever occurs first. In patients with drug-related severe toxicity S-1 dose will be adjusted or study treatment will be terminated.
In Arm B patients will continue to receive the same polychemotherapy as during induction therapy until tumor progression, toxicities requiring discontinuation, withdrawal of consent, pregnancy, death or loss to follow up whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: De-escalation therapy | Experimental | Drug: S-1 de-escalationPatients in Arm A will continue with S-1 de-escalation phase starting at week 13 until disease progression, toxicities requiring discontinuation, withdrawal of consent, pregnancy, death or lost to follow up whichever occurs first. In patients with drug-related severe toxicity S-1 dose will be adjusted or study treatment will be terminated. |
| Arm B: Chemotherapy by Investigator's choice | Experimental | Drug: Chemotherapy by Investigator's choicePatients in Arm B will continue to receive the same polychemotherapy as during induction therapy until tumor progression, toxicities requiring discontinuation, withdrawal of consent, pregnancy, death or loss to follow up whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed written informed consent incl. participation in translational research
- Male or female patient 18 years or older
- Histologically confirmed metastatic or locally advanced unresectable gastric adenocarcinoma or adenocarcinoma of the esophagus or the esophagogastric junction (Her-2/neu negative or with unknown Her-2/neu status)
- Adjuvant/neoadjuvant or perioperative chemotherapy or (chemo-)radiotherapy must have been finished at least 6 months before start of the induction therapy
- For patients enrolled before induction therapy: No previous systemic treatment (i.e. chemotherapy) for metastatic disease
Key exclusion criteria (15 listed)
- Previous major sugery within the last 28 days before the start of the induction treatment. The implantation of a central venous access (e.g. porth-a cath system) is allowed.
- History of other malignant tumors within the last 5 years before start of induction treatment, except basal cell carcinoma or curatively excised cervical carcinoma in situ
- Known brain metastases
- Concurrent radiotherapy involving target lesions used for this study. Concurrent palliative radiation for non-target lesions is allowed if other target lesions are available outside the involved field; previous radiotherapy including target lesions must have been finished at least 28 days before start of induction treatment.
- For patients enrolled before the induction therapy: Previous systemic treatment (i.e. chemotherapy) for metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-1 de-escalationAlso: TeysunoS-1 30 mg/m² bid d1-14 q21d | Drug | Arm A: De-escalation therapy |
| Chemotherapy by Investigator's choiceAlso: FLO regimen, - Oxaliplatin 85 mg/m², - Leucovorin 200 mg/m², - 5-Fluorouracil 2600 mg/m²Polychemotherapy administration as in induction therapy consists of a platinum and fluoropyrimidine compound as well as optional a taxane / an anthracycline compound. Two-Drug combinations: FLO / mod. FOLFOX-6; Cisplatin, S-1; Cisplatin, 5-FU; Cisplatin, Capecitabine (XP) Three-drug combinations: EOX/EOF FLOT | Drug | Arm B: Chemotherapy by Investigator's choice |
Primary outcome
Overall Survival (OS)
Time frame: approx. 12 month
OS will be defined as the time length between randomization and the date of death from any cause or the date of last follow-up in case of no documentation of death.
2 secondary outcomes
Progression-free survival (PFS)
Time frame: approx. 12 month
Quality of Life
Time frame: approx. 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Derived from this study: PubMed 37270871Stocker G, Lorenzen S, Ettrich T, Herz AL, Longo F, Kiani A, Venerito M, Trojan J, Mahlberg R, Moosmann N, Chibaudel B, Kubicka S, Greil R, Daum S, Geissler M, Larcher-Senn J, Keller G, Lordick F, Haag GM. S-1 maintenance therapy in Caucasian patients with metastatic esophagogastric adenocarcinoma-final results of the randomized AIO MATEO phase II trial. ESMO Open. 2023 Jun;8(3):101572. doi: 10.1016/j.esmoop.2023.101572. Epub 2023 Jun 2.
- Derived from this study: PubMed 28760152Haag GM, Stocker G, Quidde J, Jaeger D, Lordick F. Randomized controlled trial of S-1 maintenance therapy in metastatic esophagogastric cancer - the multinational MATEO study. BMC Cancer. 2017 Jul 31;17(1):509. doi: 10.1186/s12885-017-3497-9.
- Working Group for Medical Oncology (AIO) from the German Cancer Society (DKG)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Martin Haag, Dr. principal investigator
NCT-Med. Onkologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1 de-escalation and Chemotherapy by Investigator's choice in people with Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction and Gastric Neoplasm, 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 18 inclusion and 15 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 26 Mar 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 phase mean?
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?
Overall Survival (OS) (time frame: approx. 12 month). 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 NCT02128243, which also lists 2 linked publications.
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 26 Mar 2021.