The CRITICS-II trial aims to identify the optimal preoperative regimen in resectable gastric cancer by comparing three investigational treatment arms: chemotherapy vs. chemotherapy and subsequent chemoradiotherapy vs. chemoradiotherapy. The rationale behind this trial design is based on the following concepts: * Preoperative treatment is associated with better patient compliance than postoperative regimens * Preoperative treatment increases the likelihood of disease downsizing/downstaging and radical R0 resections * Preoperative paclitaxel/carboplatin-based concurrent chemoradiotherapy and DOC chemotherapy are effective, feasible and safe regimens
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
207
3 weekly course of docetaxel i.v in arm 1 and 2
3 weekly course oxaliplatin as a 2 hr i.v. in arm 1 and 2
oral capecitabine in arm 1 and 2
resection of gastric cancer after pre-operative chemotherapy for all arms
5 weeks of radiation, 5 times a week with a total of 45 Gy (in arm 2 and 3)
5 weeks of paclitaxel i.v once a week (in arm 2 and 3)
5 weeks of carboplatin i.v once a week (in arm 2 and 3)
Zuyderland Medisch Centrum
Sittard-Geleen, Limburg, Netherlands
Viecuri Medisch Centrum
Venlo, Limburg, Netherlands
Elkerliek
Deurne, North Brabant, Netherlands
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands
Maxima Medisch Centrum
Eindhoven, North Brabant, Netherlands
St. Anna Zorggroep
Geldrop, North Brabant, Netherlands
Elkerliek
Helmond, North Brabant, Netherlands
Instituut Verbeeten
Tilburg, North Brabant, Netherlands
Bernhoven
Uden, North Brabant, Netherlands
Maxima Medisch Centrum
Veldhoven, North Brabant, Netherlands
...and 18 more locations
Event-Free survival
Event-free survival will be measured by clinical outcome and CT-scan
Time frame: 1 year
Time to Event (events: local recurrence, regional recurrence, local-regional recurrence or progression, distant recurrence, or death from any cause)
Interval between randomization and event measured by clinical outcome and CT scan
Time frame: 1 year
Time to recurrence (events: local recurrence, regional recurrence, local-regional recurrence or progression, distant recurrence)
Interval between randomization and recurrence determined by clinical outcome and CT scan
Time frame: 1 year
Toxicity
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.