Gastric Cancer
Conditions
Keywords
gastric cancer, radiotherapy, chemoradiotherapy
Brief summary
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
Interventions
RADIATIONradiotherapy of gastric cancer
5 weeks of radiation, 5 times a week with a total of 45 Gy (in arm 2 and 3)
DRUGDocetaxel
3 weekly course of docetaxel i.v in arm 1 and 2
DRUGOxaliplatin
3 weekly course oxaliplatin as a 2 hr i.v. in arm 1 and 2
DRUGCapecitabine
oral capecitabine in arm 1 and 2
PROCEDUREgastrectomy
resection of gastric cancer after pre-operative chemotherapy for all arms
DRUGPaclitaxel
5 weeks of paclitaxel i.v once a week (in arm 2 and 3)
DRUGCarboplatin
5 weeks of carboplatin i.v once a week (in arm 2 and 3)
Sponsors
The Netherlands Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* TNM 8th ed stage IB-IIIC gastric cancer (histologically proven); tumour bulk has to be in the stomach but may involve gastro-oesophageal junction * WHO \< 2 * Age ≥ 18 yrs * Resectable adenocarcinoma of the stomach or gastro-oesophageal junction * No prior abdominal radiotherapy * Haematology: Hb ≥5.0 mmol/l; leukocytes≥3.0x109/l, neutrophils ≥1.5x109/l, thrombocytes ≥100x109/l * Renal function: serum creatinine ≤1.25x ULN, creatinine clearance ≥ 50 ml/min (calculated by Cockcroft and Gault formula) Liver function: total bilirubin ≤1.5x ULN, alkaline phosphatase and ASAT/ALAT ≤ 3x ULN * At staging laparoscopy (mandatory) obtained biopsies of suspected peritoneal lesions and/or substantial free peritoneal fluid if any should be pathologically proven tumor negative * Written informed consent * Expected adequacy of follow-up * Caloric intake≥1500 kcal/day, verified by a dietician before registration. * if caloric intake is \< 1500 kcal/day or if bodyweight has decreased \> 10% over the last 6 months or \> 5% over the last month, dietary intervention such as oral nutritional support or enteral tube feeding is mandatory
Exclusion criteria
* T1N0 disease (assessed by endoscopic ultrasound) * Distant metastases * Inoperable patients; due to technical surgery-related factors or general condition * Previous malignancy, except adequately treated non-melanoma skin cancer or in-situ cancer of the cervix uteri; in case of a previous other malignancy with a disease-free period≥5 years, inclusion can be accepted after consultation of the principal investigator * Solitary functioning kidney that will be within the radiation field * Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery * Uncontrolled (bacterial) infections * Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments * Uncontrolled angina pectoris, cardiac failure or clinically significant arrhythmias * Continuous use of immunosuppressive agents equivalent to \>10 mg daily prednison * Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine * Neurotoxicity \> CTC grade 1 * Pregnancy or breast feeding * Patients (M/F) with reproductive potential not implementing adequate contraceptive measures * Gastric or gastro-esophageal stent within radiation field
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-Free survival | 1 year | Event-free survival will be measured by clinical outcome and CT-scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Event (events: local recurrence, regional recurrence, local-regional recurrence or progression, distant recurrence, or death from any cause) | 1 year | Interval between randomization and event measured by clinical outcome and CT scan |
| Time to recurrence (events: local recurrence, regional recurrence, local-regional recurrence or progression, distant recurrence) | 1 year | Interval between randomization and recurrence determined by clinical outcome and CT scan |
| Toxicity | 1 year | Number of patients with treatment-related adverse events as assessed by CTCAE v4.0 |
Countries
Netherlands
Outcome results
None listed