Who is sponsoring ITACA-S2?

ITACA-S2 is sponsored by Mario Negri Institute for Pharmacological Research.

What condition does ITACA-S2 study?

ITACA-S2 studies Gastric Adenocarcinoma.

What drugs are being tested in ITACA-S2?

Interventions: peri-operative cht, post-operative CHT, peri-operative cht + post-operative cht-rtx, post-operative cht + post-operative cht-rtx.

What is the status of ITACA-S2?

ITACA-S2 is currently TERMINATED.

Last reviewed 2015-01-28 · How we verify

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.

NCT01989858 Phase 3 TERMINATED

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.

Details

Lead sponsor	Mario Negri Institute for Pharmacological Research
Phase	Phase 3
Status	TERMINATED
Enrolment	1180
Start date	2010-11
Completion	2013-12

Conditions

Gastric Adenocarcinoma

Interventions

peri-operative cht
post-operative CHT
peri-operative cht + post-operative cht-rtx
post-operative cht + post-operative cht-rtx

Primary outcomes

Overall survival (OS)- Timing Study — 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.

Countries

Italy