Gastric AdenocarcinomaPhase 3ITACA-S2NCT01989858
ITACA-S2 (Intergroup Trial in Adjuvant Chemotherapy for Adenocarcinoma of the Stomach)
A Phase 3 study testing peri-operative cht, post-operative CHT and peri-operative cht + post-operative cht-rtx in people with Gastric Adenocarcinoma, run by Mario Negri Institute for Pharmacological Research at 32 sites in Italy.
Trial summary
The study addresses two primary questions, according to its factorial design: to compare the efficacy in terms of overall survival (OS) of a peri-operative vs. a post-operative chemotherapy (CHT) treatment, irrespectively of the presence of a post-surgical chemo-radiotherapy (CHT-RTX) (Timing Study); to compare the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- peri-operative cht, post-operative CHT and peri-operative cht + post-operative cht-rtx
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,180 participants
- Where
- 32 sitesItaly
- Study dates
- Nov 2010to Dec 2013
- Phase
- Phase 3
- 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
- age >18 years
- Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) 0-1
- T3 or T4 carcinoma without lymphnode involvement (N0) and any T-stage with (N+) lymphnode involvement
- no distant metastases (M0)
- fitness to receive CHT and CHT-RTX
- no peripheral neuropathy greater than grade 1
- absence of peritoneal carcinomatosis
- written informed consents (one for each trial) given before the randomization, according to International Conference on Harmonisation/Good Clinical Practice (ICH/GCP)
Who cannot join
- adenocarcinoma of the gastro-esophageal junction
- previous CHT or RTX
- abnormal haematological, hepatic or renal functions, assessed within 7 days prior to randomization
- lymphnode metastases (biopsy proof, if possible) outside the loco-regional field, such as supraclavicular, mediastinal or para-aortic nodes
- positive peritoneal cytology
- clinical significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤ 6 months), myocardial infarction (≤ 6 months), instable angina, New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
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- lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication
- history or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or patients at high risk from treatment complications
- pregnancy or breast feeding. Women of childbearing potential and their parents must be willing to practice acceptable methods of birth control to prevent pregnancy
- presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and f-up schedule
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Italy32 sites
Ospedali Riuniti di Bergamo
Bergamo, BG, 24128
A.O. Sant'Orsola Malpighi
Bologna, BO, 40138
Policlinico Sant'Orsola Malpighi
Bologna, BO, 40138
A. O. "Ospedale di Circolo di Busto Arsizio" - Busto Arsizio (VA)
Busto Arsizio, VA, 21052
IRCC/FPO -Istituto per la Ricerca e la Cura del Cancro di Candiolo
Candiolo, TO, 10060
Ospedale "Ramazzini " di Carpi
Carpi, MO, 41012
Azienda Ospedaliero-Universitaria "Policlinico-Vittorio Emanuele"
Catania, CT, 95123
Policlinico Universitario Mater Domini
Catanzaro, CZ, 88100
A.O. Santa Croce e Carle
Cuneo, CN, 12100
Ospedale Santa Croce Fano
Fano, PU, 61032
Azienda Ospedaliero- Universitaria Careggi - Firenze
Florence, FI, 50141
A. O. "Carlo Poma"
Mantua, MN, 46100
Fondazione IRCCS Ospedale Maggiore Policlinico
Milan, MI, 20122
Istituto Nazionale per la Cura e lo Studio dei Tumori
Milan, MI, 20133
Istituto Oncologico Europeo
Milan, MI, 20141
Azienda Ospedaliera "San Paolo"
Milan, MI, 20142
A.O. Ospedale San Gerardo
Monza, MB, 20052
Fondazione "G. Pascale" Istituto Tumori di Napoli
Naples, 80131
IRCCS Istituto Oncologico Veneto
Padova, PD, 35128
Ospedale "Guglielmo da Saliceto"
Piacenza, PC, 29100
Azienda Ospedaliera 'San Carlo'
Potenza, PZ, 85100
Ospedale Misericordia e Dolce - USL 4
Prato, PO, 59100
Arcispedale S. Maria Nuova Azienda Ospedaliera
Reggio Emilia, RE, 42100
Università "Campus Bio-Medico"
Roma, RM, 00128
Policlinico Universitario A. Gemelli
Roma, RM, 00168
Istituto Clinico Humanitas
Rozzano, MI, 20089
A. O. Busto Arsizio - P.O. Saronno
Saronno, VA, 21047
Casa di Cura MultiMedica
Sesto San Giovanni, MI, 20099
A.O. della Valtellina e della Valchiavenna - "Ospedale E. Morelli"
Sondalo, SO, 23100
A. O. Ospedale Treviglio-Caravaggio
Treviglio, BG, 24047
A.O. Ospedale di Circolo e Fondazione Macchi
Varese, VA, 21100
Azienda Ospedaliera di Desio e Vimercate
Vimercate, MB, 20059
About this study
Official title: ITACA-S2(Intergroup Trial in Adjuvant Chemotherapy for Adenocarcinoma of the Stomach:Comparison of the Efficacy of a Peri-operative Versus a Post-operative Chemotherapy Treatment in Patients With Operable Gastric Cancer and Assessment of the Benefit of a Post-operative Chemo-radiotherapy.
The study addresses two primary questions, according to its factorial design:
- to compare the efficacy in terms of overall survival (OS) of a peri-operative vs. a post-operative chemotherapy (CHT) treatment, irrespectively of the presence of a post-surgical chemo-radiotherapy (CHT-RTX) (Timing Study);
- to compare the efficacy in terms of relapse free survival (l-RFS) of a post-surgical CHT-RTX treatment vs. no other treatment, irrespectively of the timing of CHT (RTX Study).
Read more
The study has a 2x2 factorial design, thus consisting of two independent, following specific eligibility criteria and with different randomization scheme studies, the Timing Study and the RTX Study.
Both studies are Italian, multicentre, open-label, randomized, superiority, phase III trials conducted in patients with histologically confirmed, localized gastric adenocarcinoma, which is considered operable.
In the Timing Study patients fulfilling the eligibility criteria will be randomized with a 1:1 ratio to receive:
- peri-operative CHT (Arm A) or
- post-operative CHT (Arm B) Once randomized in the Timing Study, patients may also be randomized in the RTX
Study to receive in addition to CHT a post-operative CHT-RTX treatment or no other treatment. This is possible since the randomization will be done in two steps: the first for the Timing Study for all the participating centres (peri-operative CHT vs. post-operative CHT) and the second one for the RTX Study, only for those centres with the radiotherapist willing and able to participate (post- surgical CHT-RTX vs. no other treatment). Thus the following four arms will be generated:
- peri-operative CHT (Arm A)
- post-operative CHT (Arm B)
- peri-operative CHT + post-operative CHT-RTX (Arm C)
- post-operative CHT + post-operative CHT-RTX (Arm D) The study will be conducted in more than one hundred experimental centres. Follow-up F(-up) procedures and timing of the visits will be consistent with current clinical practice.
Based on case-mix of sample 1000-1180 patients are needed in the Timing study and 420-520 in the RTX study.
- Conditions
- Gastric Adenocarcinoma
- Being tested
- peri-operative cht, post-operative CHT, peri-operative cht + post-operative cht-rtx, post-operative cht + post-operative cht-rtx
- Keywords
- localized gastric adenocarcinoma, operable considered.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peri-operative chtOther
CHT treatment have to be chosen between the following associations:
Chemotherapy regimen containing epirubicin, cisplatin and capecitabine (EOX) E: epirubicin 50 mg/m² intravenous (iv) bolus, day 1 every 3 weeks O: oxaliplatin 130 mg/m² iv infusion, day 1 in 2-3 hours every 3 weeks X: capecitabine 625 mg/m² bis in die (bid), day 1 per os (po) continuously
or
Chemotherapy regimen containing epirubicin, cisplatin and 5-fluorouracil (ECF) E: epirubicin 50 mg/m² iv bolus, day 1 every 3 weeks C: cisplatin 60 mg/m² iv with standard hydration day 1 every 3 weeks F: 5FU 200 mg/m² daily by continuous infusion via central line.
post-operative CHTOther
CHT treatment have to be chosen between the following associations:
EOX E: epirubicin 50 mg/m² intravenous (iv) bolus, day 1 every 3 weeks O: oxaliplatin 130 mg/m² iv infusion, day 1 in 2-3 hours every 3 weeks X: capecitabine 625 mg/m² bis in die (bid), day 1 per os (po) continuously
or ECF E: epirubicin 50 mg/m² iv bolus, day 1 every 3 weeks C: cisplatin 60 mg/m² iv with standard hydration day 1 every 3 weeks F: 5fluorouracil (5FU) 200 mg/m² daily by continuous infusion via central line.
peri-operative cht + post-operative cht-rtxOther
CHT treatment have to be chosen between the following associations:
- EOX E: epirubicin 50 mg/m² intravenous (iv) bolus, day 1 every 3 weeks O: oxaliplatin 130 mg/m² iv infusion, day 1 in 2-3 hours every 3 weeks X: capecitabine 625 mg/m² bis in die (bid), day 1 per os (po) continuously or
- ECF E: epirubicin 50 mg/m² iv bolus, day 1 every 3 weeks C: cisplatin 60 mg/m² iv with standard hydration day 1 every 3 weeks F: 5FU 200 mg/m² daily by continuous infusion via central line.
The prescribed RTX dose to clinical target volume should be 45 gray (Gy) delivered in daily fraction of 1.8 Gy, five times per week for six weeks. RTX will be administered concurrently with CHT. The choice of the associated CHT should be between the following schedules:
- 5FU 225 mg/m² given as a continuous iv infusion or
- capecitabine 825 mg/m² bid given as a continuous oral administration during the entire course of RTX.
post-operative cht + post-operative cht-rtxOther
CHT treatment have to be chosen between the following associations:
- EOX E: epirubicin 50 mg/m² intravenous (iv) bolus, day 1 every 3 weeks O: oxaliplatin 130 mg/m² iv infusion, day 1 in 2-3 hours every 3 weeks X: capecitabine 625 mg/m² bis in die (bid), day 1 per os (po) continuously or
- ECF E: epirubicin 50 mg/m² iv bolus, day 1 every 3 weeks C: cisplatin 60 mg/m² iv with standard hydration day 1 every 3 weeks F: 5FU 200 mg/m² daily by continuous infusion via central line.
The prescribed RTX dose to clinical target volume should be 45 gray (Gy) delivered in daily fraction of 1.8 Gy, five times per week for six weeks. RTX will be administered concurrently with CHT. The choice of the associated CHT should be between the following schedules:
- 5FU 225 mg/m² given as a continuous iv infusion or
- capecitabine 825 mg/m² bid given as a continuous oral administration during the entire course of RTX.
| Study group | Role | What they receive |
|---|---|---|
| peri-operative CHT (Arm A) | Experimental | In peri-operative CHT arm CHT will be administered within 1 week (+3 days) after randomization, surgery will be performed after re-staging and 3+1 weeks after completion of the third cycle of CHT (approximately 13+1 weeks after randomization). Then CHT will be re-administered 5+1 weeks after surgery. Receives: Other: peri-operative cht |
| post-operative CHT (Arm B) | Active comparator | In post-operative CHT arm, surgery will take place 3+1 weeks after randomization and CHT will be administered 5+1 weeks after surgery (approximately 8+1 weeks after randomization). Receives: Other: post-operative CHT |
| peri-operative CHT + post-operative CHT-RTX (Arm C) | Experimental | CHT 1 week (+3 days) after randomization surgery after re-staging and 3+1 weeks after completion of the third cycle of CHT CHT 5+1 weeks after surgery. Receives: Other: peri-operative cht + post-operative cht-rtx |
| post-operative CHT + post-operative CHT-RTX (Arm D) | Active comparator | surgery will take place 3+1 weeks after randomization and CHT will be administered 5+1 weeks after surgery (approximately 8+1 weeks after randomization). Receives: Other: post-operative cht + post-operative cht-rtx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)- Timing Study
OS, defined for each patient as the time from the date of randomization to the date of death from any cause. Patients not reported as having died at the end of the study will be censored at the date they were last known to be alive.
Measured: 5 years
Secondary outcomes (4)
Dose-intensity
- Dose-intensity, that is the dose of effective drug administrated per unit time (mg/m2/week or Gy/week)
- Dose and/or time modifications
- Premature withdrawals
Measured: up to 8 weeks
Maximum toxicity grade
- Maximum toxicity grade experienced by each patient for each toxicity
- Patients experiencing grade 3-4 toxicity for each toxicity
- Type,frequency and nature of serious adverse events (SAEs)
- Patients with at least a SAE
- Patients with at least a serious adverse drug reaction (SADR)
Measured: up to 8 weeks
Disease Free Survival (DFS) - Timing Study
DFS, defined for each patient as the time from the date of randomization to the date of local or regional relapse, distant metastasis, second primary malignancy or death from any cause, whichever comes first. Patients not recurred, progressed or died while on study or lost to f-up will be censored at their last disease assessment date.
Measured: 3 years
Relapse Free Survival (l-RFS)- RTX Study
1-RFS, defined for each patient as the time from the date of randomization to the date of first local recurrence or death from any cause, whichever comes first.
Description: 1-RFS, defined for each patient as the time from the date of randomization to the date of first local recurrence or death from any cause, whichever comes first. Patients not locally recurred or died while on study or lost to f-up will be censored at their last disease assessment date
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startNov 2010
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: lack of clinical cases
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,180 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Di Costanzo, MD, Principal investigator, Azienda Ospedaliero- Universitaria Careggi - Firenze U.O. Medica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989858
- Sponsor's protocol ID
- 2010-021052-25
- Acronym
- ITACA-S2
- Status last verified
- Jul 2010
- First submitted
- 16 Jun 2011
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ITACA-S2(Intergroup Trial in Adjuvant Chemotherapy for Adenocarcinoma of the Stomach:Comparison of the Efficacy of a Peri-operative Versus a Post-operative Chemotherapy Treatment in Patients With Operable Gastric Cancer and Assessment of the Benefit of a Post-operative Chemo-radiotherapy.
- ClinicalTrials.gov ID
- NCT01989858
- Acronym / sponsor ID
- ITACA-S2 / 2010-021052-25
- Conditions
- Gastric Adenocarcinoma
- Keywords
- localized gastric adenocarcinoma, operable considered.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of clinical cases
- Enrolment
- 1,180 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Nov 2013 (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 study addresses two primary questions, according to its factorial design:
- to compare the efficacy in terms of overall survival (OS) of a peri-operative vs. a post-operative chemotherapy (CHT) treatment, irrespectively of the presence of a post-surgical chemo-radiotherapy (CHT-RTX) (Timing Study);
- to compare the efficacy in terms of relapse free survival (l-RFS) of a post-surgical CHT-RTX treatment vs. no other treatment, irrespectively of the timing of CHT (RTX Study).
The study has a 2x2 factorial design, thus consisting of two independent, following specific eligibility criteria and with different randomization scheme studies, the Timing Study and the RTX Study.
Both studies are Italian, multicentre, open-label, randomized, superiority, phase III trials conducted in patients with histologically confirmed, localized gastric adenocarcinoma, which is considered operable.
In the Timing Study patients fulfilling the eligibility criteria will be randomized with a 1:1 ratio to receive:
- peri-operative CHT (Arm A) or
- post-operative CHT (Arm B) Once randomized in the Timing Study, patients may also be randomized in the RTX
Study to receive in addition to CHT a post-operative CHT-RTX treatment or no other treatment. This is possible since the randomization will be done in two steps: the first for the Timing Study for all the participating centres (peri-operative CHT vs. post-operative CHT) and the second one for the RTX Study, only for those centres with the radiotherapist willing and able to participate (post- surgical CHT-RTX vs. no other treatment). Thus the following four arms will be generated:
- peri-operative CHT (Arm A)
- post-operative CHT (Arm B)
- peri-operative CHT + post-operative CHT-RTX (Arm C)
- post-operative CHT + post-operative CHT-RTX (Arm D) The study will be conducted in more than one hundred experimental centres. Follow-up F(-up) procedures and timing of the visits will be consistent with current clinical practice.
Based on case-mix of sample 1000-1180 patients are needed in the Timing study and 420-520 in the RTX study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| peri-operative CHT (Arm A) | Experimental | Other: peri-operative chtIn peri-operative CHT arm CHT will be administered within 1 week (+3 days) after randomization, surgery will be performed after re-staging and 3+1 weeks after completion of the third cycle of CHT (approximately 13+1 weeks after randomization). Then CHT will be re-administered 5+1 weeks after surgery. |
| post-operative CHT (Arm B) | Active comparator | Other: post-operative CHTIn post-operative CHT arm, surgery will take place 3+1 weeks after randomization and CHT will be administered 5+1 weeks after surgery (approximately 8+1 weeks after randomization). |
| peri-operative CHT + post-operative CHT-RTX (Arm C) | Experimental | Other: peri-operative cht + post-operative cht-rtxCHT 1 week (+3 days) after randomization surgery after re-staging and 3+1 weeks after completion of the third cycle of CHT CHT 5+1 weeks after surgery. |
| post-operative CHT + post-operative CHT-RTX (Arm D) | Active comparator | Other: post-operative cht + post-operative cht-rtxsurgery will take place 3+1 weeks after randomization and CHT will be administered 5+1 weeks after surgery (approximately 8+1 weeks after randomization). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age >18 years
- Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) 0-1
- T3 or T4 carcinoma without lymphnode involvement (N0) and any T-stage with (N+) lymphnode involvement
- no distant metastases (M0)
- fitness to receive CHT and CHT-RTX
Key exclusion criteria (10 listed)
- adenocarcinoma of the gastro-esophageal junction
- previous CHT or RTX
- abnormal haematological, hepatic or renal functions, assessed within 7 days prior to randomization
- lymphnode metastases (biopsy proof, if possible) outside the loco-regional field, such as supraclavicular, mediastinal or para-aortic nodes
- positive peritoneal cytology
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 |
|---|---|---|
| peri-operative chtCHT treatment have to be chosen between the following associations: Chemotherapy regimen containing epirubicin, cisplatin and capecitabine (EOX) E: epirubicin 50 mg/m² intravenous (iv) bolus, day 1 every 3 weeks O: oxaliplatin 130 mg/m² iv infusion, day 1 in 2-3 hours every 3 weeks X: capecitabine 625 mg/m² bis in die (bid), day 1 per os (po) continuously or Chemotherapy regimen containing epirubicin, cisplatin and 5-fluorouracil (ECF) E: epirubicin 50 mg/m² iv bolus, day 1 every 3 weeks C: cisplatin 60 mg/m² iv with standard hydration day 1 every 3 weeks F: 5FU 200 mg/m² daily by continuous infusion via central line. | Other | peri-operative CHT (Arm A) |
| post-operative CHTCHT treatment have to be chosen between the following associations: EOX E: epirubicin 50 mg/m² intravenous (iv) bolus, day 1 every 3 weeks O: oxaliplatin 130 mg/m² iv infusion, day 1 in 2-3 hours every 3 weeks X: capecitabine 625 mg/m² bis in die (bid), day 1 per os (po) continuously or ECF E: epirubicin 50 mg/m² iv bolus, day 1 every 3 weeks C: cisplatin 60 mg/m² iv with standard hydration day 1 every 3 weeks F: 5fluorouracil (5FU) 200 mg/m² daily by continuous infusion via central line. | Other | post-operative CHT (Arm B) |
| peri-operative cht + post-operative cht-rtxCHT treatment have to be chosen between the following associations: * EOX E: epirubicin 50 mg/m² intravenous (iv) bolus, day 1 every 3 weeks O: oxaliplatin 130 mg/m² iv infusion, day 1 in 2-3 hours every 3 weeks X: capecitabine 625 mg/m² bis in die (bid), day 1 per os (po) continuously or * ECF E: epirubicin 50 mg/m² iv bolus, day 1 every 3 weeks C: cisplatin 60 mg/m² iv with standard hydration day 1 every 3 weeks F: 5FU 200 mg/m² daily by continuous infusion via central line. The prescribed RTX dose to clinical target volume should be 45 gray (Gy) delivered in daily fraction of 1.8 Gy, five times per week for six weeks. RTX will be administered concurrently with CHT. The choice of the associated CHT should be between the following schedules: * 5FU 225 mg/m² given as a continuous iv infusion or * capecitabine 825 mg/m² bid given as a continuous oral administration during the entire course of RTX. | Other | peri-operative CHT + post-operative CHT-RTX (Arm C) |
| post-operative cht + post-operative cht-rtxCHT treatment have to be chosen between the following associations: * EOX E: epirubicin 50 mg/m² intravenous (iv) bolus, day 1 every 3 weeks O: oxaliplatin 130 mg/m² iv infusion, day 1 in 2-3 hours every 3 weeks X: capecitabine 625 mg/m² bis in die (bid), day 1 per os (po) continuously or * ECF E: epirubicin 50 mg/m² iv bolus, day 1 every 3 weeks C: cisplatin 60 mg/m² iv with standard hydration day 1 every 3 weeks F: 5FU 200 mg/m² daily by continuous infusion via central line. The prescribed RTX dose to clinical target volume should be 45 gray (Gy) delivered in daily fraction of 1.8 Gy, five times per week for six weeks. RTX will be administered concurrently with CHT. The choice of the associated CHT should be between the following schedules: * 5FU 225 mg/m² given as a continuous iv infusion or * capecitabine 825 mg/m² bid given as a continuous oral administration during the entire course of RTX. | Other | post-operative CHT + post-operative CHT-RTX (Arm D) |
Primary outcome
Overall survival (OS)- Timing Study
Time frame: 5 years
OS, defined for each patient as the time from the date of randomization to the date of death from any cause. Patients not reported as having died at the end of the study will be censored at the date they were last known to be alive.
4 secondary outcomes
Dose-intensity
Time frame: up to 8 weeks
Maximum toxicity grade
Time frame: up to 8 weeks
Disease Free Survival (DFS) - Timing Study
Time frame: 3 years
Relapse Free Survival (l-RFS)- RTX Study
Time frame: 3 years
Results and safety
The study was stopped early (reason given: lack of clinical cases). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
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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.
Francesco Di Costanzo, MD principal investigator
Azienda Ospedaliero- Universitaria Careggi - Firenze U.O. Medica
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing peri-operative cht, post-operative CHT and peri-operative cht + post-operative cht-rtx in people with Gastric Adenocarcinoma, run by Mario Negri Institute for Pharmacological Research at 32 sites in Italy.
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 10 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: stopped early, as of the sponsor's last update on 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: lack of clinical cases). Results are not available in the source record.
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)- Timing Study (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2015; AzTrials last refreshed its copy on 7 Nov 2026.