Trial Evaluating the Efficacy and Tolerance of Perioperative Chemotherapy With 5FU-Cisplatin-Cetuximab in Adenocarcinomas of the Stomach and Gastroesophageal Junction. Phase II Single Arm, Multicenter.
- To evaluate the objective response rate according to RECIST V1.1 criteria in patients
with adenocarcinoma of the stomach or gastroesophageal junction treated with
neoadjuvant chemotherapy comprising fluorouracil, cisplatin, leucovorin calcium, and
cetuximab followed by surgery and adjuvant chemotherapy.
- To determine the non-toxicity rate in these patients.
- To determine the rate of macroscopically and microscopically complete surgical
- To determine the overall tolerance in patients treated with this regimen.
- To determine post-operative mortality and morbidity in these patients.
- To determine the rate of recurrence at 1 and 2 years in these patients.
- To determine recurrence-free survival at 3 years in these patients.
- To determine disease-free survival at 3 years in these patients.
- To determine overall survival at 3 years in these patients.
- To determine quality of life using EORTC QLC-C30 and STO-22 questionnaires.
- To determine the correlation between the response rate and the degree of skin toxicity.
OUTLINE: This is a multicenter study.
- Neoadjuvant therapy and surgery: Patients receive leucovorin calcium IV over 2 hours,
cisplatin IV, fluorouracil IV continuously over 46 hours, and cetuximab IV over 1-2
hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease
progression or unacceptable toxicity. Within 3-4 weeks after completing neoadjuvant
chemotherapy, patients undergo surgery.
- Adjuvant therapy: Within 4-8 weeks after completing neoadjuvant chemotherapy, patients
receive leucovorin calcium, cisplatin, fluorouracil, and cetuximab as in neoadjuvant
therapy. Treatment repeats every 2 weeks for 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients complete quality-of-life questionnaires (QLC-C30 and STO-22) periodically. Blood
and tissue samples are collected periodically for correlative and translational studies.
After completing study therapy, patients are followed up every 4 months for 2 years and then
every 6 months for 1 year.
Masking: Open Label, Primary Purpose: Treatment
Objective response rate according to RECIST V1.1 criteria
Christophe Mariette, MD, PhD
Centre Hospitalier Regional et Universitaire de Lille