Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach

Phase 3 Completed 1100 enrolled Mario Negri Institute for Pharmacological Research Aventis Pharmaceuticals · collab Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente · collab Gruppo Oncologico Italiano di Ricerca Clinica · collab Gruppo Oncologico del Nord-Ovest · collab Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · collab Italian Trial in Medical Oncology · collab Oncotech · collab Southern Italy Cooperative Oncology Group · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Open label, randomised, multicenter, superiority study for efficacy. Patients with histologically proven adenocarcinoma of the stomach or gastroesophageal junction without gross or microscopic evidence of residual disease after surgery with curative intent and fulfilling all the inclusion/exclusion criteria are eligible for this study.

Timeline

Start: 2005-02
Primary completion: 2013-01
Completion: 2013-01

Outcome

Missed primary endpoint

paper No statistically significant difference was detected for both disease-free [hazard ratio (HR) 1.00; 95% confidence interval (CI): 0.85-1.17; P = 0.974] PMID 24728035 ↗

paper A more intensive regimen failed to show any benefit in disease-free and OS versus monotherapy. PMID 24728035 ↗

Publications

Bajetta E, Floriani I, Di Bartolomeo M, Labianca R, Falcone A, Di Costanzo F, Comella G, Amadori D, Pinto C, Carlomagno C, Nitti D, Daniele B, Mini E, Poli D, Santoro A, Mosconi S, Casaretti R, Boni C, Pinotti G, Bidoli P, Landi L, Rosati G, Ravaioli A, Cantore M, Di Fabio F, Aitini E, Marchet A; ITACA-S (Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach Trial) Study Group. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer. Ann Oncol. 2014 Jul;25(7):1373-1378. doi: 10.1093/annonc/mdu146. Epub 2014 Apr 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Irinotecan	Small molecule	180 mg/m2	Intravenous
Comparator	Leucovorin	Small molecule	100 mg/m2	Intravenous
Comparator	fluorouracil	Small molecule	400 mg/m2	Intravenous
Comparator	fluorouracil	Small molecule	600 mg/m2	Intravenous