NCT01498289.

Trial name or title	A randomized phase II pilot study prospectively evaluating treatment for participants based on ERCC1(excision repair cross‐complementing 1) for advanced/metastatic oesophageal, gastric or gastroesophageal junction (GEJ) cancer
Methods	Multicentre RCT 2 arms stratification according to ERCC1
Participants	N = 225 with unresectable, advanced or recurrent gastric cancer, age ≥18 years, HER‐2 negative
Interventions	Arm A (FOLFOX): 4‐FU (bolus 400 mg/m², ci 2400 mg/m² )+ LV (400 mg/m²) + oxaliplatin (85 mg/m²) d 1, repeated at d 14. Arm B docetaxel (30 mg/m² on day 1 + 8 qd 21) + irinotecan (65 mg/m² on day 1 + 8 qd 21).
Outcomes	Progression‐free survival (PFS) between high‐ERCC1 and low‐ERCC1 participants treated with FOLFOX versus irinotecan hydrochloride plus docetaxel, overall survival, response rate, toxicity
Starting date	February 2012
Contact information	Contact: Kimberly Kaberle: kkaberle@swog.org; Dana Sparks: dsparks@swog.org Principal Investigator: Syma Iqbal
Notes	Sponsors: Southwest Oncology Group and National Cancer Institute (NCI)