NCT01717924RecruitingNot Applicable
Multicenter Randomized Controlled Trial to Evaluate the Strategy of Primary Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma (ADCI002 Study)
University Hospital, Lille1 site in 1 country314 target enrollmentStarted: October 1, 2012Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 314
- Locations
- 1
- Primary Endpoint
- Percentage of patients dead in the 2-years
Study Overview
Brief Summary
The ADCI 002 trial is a large multicenter phase II-III prospective randomized controlled trial comparing primary surgery versus primary chemotherapy followed by surgery in patients with a resectable signet ring cell gastric adenocarcinoma
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adenocarcinoma of the stomach or the oesogastric junction of type III of Siewert classification,histologically proven with the presence of signet ring cells (according to WHO 2000 classification) or diffuse form (according to Lauren classification) on pre-therapeutic biopsies
- •tumoural stage IB, II or III (according to UICC-AJCC 2009)
- •patient judged resectable in a curative intent on inclusion
- •absence of distant metastasis
- •absence of peritoneal carcinomatosis during pre-treatment explorative laparoscopy
- •WHO performance status 2 or less
- •age over 18 or under 80 years
- •weight loss at the time of inclusion < 15%
- •neutrophilic polynuclears more than 1500/mm3
- •platelets more than 100000/mm3
- •creatinine clearance more than 50 ml/min
- •serum-albumin more than 30 gram/l
- •bilirubin less than 1,5 normal
- •prothrombin rate over 80%
- •absence of prior treatment with chemotherapy or radiotherapy for gastric cancer
- •absence of kniwn child B or C cirrhosis
- •left ventricular ejection fraction more than 50% before epirubicin treatment
- •extension check-up performed within 4 weeks of inclusion
- •signed written informed consent given by the patient
Exclusion Criteria
- •no corresponding to the inclusion criteria
- •another malignant tumour treated for curative purposes during the past 5 years excepted basocellular skin carcinoma or in situ uterine cervix cancer
- •allergy to the active substance or one of the excipients in the study drugs
- •pregnancy or breast-feeding
- •any other concommitant treatment, immunotherapy or hormonal therapy
- •history of abdominal or chest radiotherapy
- •any evolving disorder which is not under control (liver failure, kidney failure, respiratory failure, evolving heart failure or myocardial necrosis during the past 6 months)
- •patients who cannot be regularly monitored
Arms & Interventions
peri-operative chemotherapy
Active Comparator
Neoadjuvant chemotherapy with 3 cycles of Epirubicin/Cisplatin/5 fluoro-uracil (oral or intra-veinous) Surgery within 3 and 6 weeks after the end of neoadjuvant chemotherapy Adjuvant chemotherapy with 3 cycles of the same chemotherapy within 6 and 12 weeks after surgery
Intervention: peri-operative chemotherapy (Procedure)
surgery first with adjuvant chemotherapy
Experimental
Surgery first Adjuvant chemotherapy with 3 cycles of Epirubicin/Cisplatin/5FU within 6 and 12 weeks after surgery No neoadjuvant chemotherapy
Intervention: Surgery first (Procedure)
Outcomes
Primary Outcomes
Percentage of patients dead in the 2-years
Time Frame: 2 years
Secondary Outcomes
- grade III/IV toxicity(2 years)
- post operative morbi-mortality(2 years)
- Average of patients who benefit from the overall treatment strategy(2 years)
- Disease-free survival at 2 years(2 years)
- Disease-free survival at 3 years(3 years)
- Overall survival at 3 years(3 years)
- R0 resection rate(within 1 year)
- quality of life(2 years)
- emotional status(2 years)
Investigators
Study Sites (1)
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