Recruiting NCT01717924
Evaluation of Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: peri-operative chemotherapy, Surgery first.
- Who it may be relevant to
- Registry conditions: Signet Ring Cell Gastric Adenocarcinoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicenter Randomized Controlled Trial to Evaluate the Strategy of Primary Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma (ADCI002 Study)
Overview
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
Interventions
- Procedure peri-operative chemotherapy
Usual treatment strategy for gastric adenocarcinoma - Procedure Surgery first
strategy with a surgical procedure first, without the usual peri-operative chemotherapy
Primary outcome measures
- Percentage of patients dead in the 2-years [Time frame: 2 years]
Secondary outcome measures (9)
- Disease-free survival at 2 years [Time frame: 2 years]
- Disease-free survival at 3 years [Time frame: 3 years]
- Overall survival at 3 years [Time frame: 3 years]
- R0 resection rate [Time frame: within 1 year]
- grade III/IV toxicity [Time frame: 2 years]
- post operative morbi-mortality [Time frame: 2 years]
- Average of patients who benefit from the overall treatment strategy [Time frame: 2 years]
- quality of life [Time frame: 2 years]
- emotional status [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- General and digestive surgical department, Claude Huriez Hospital, University Hospital — Lille
Publications
- Piessen G, Messager M, Le Malicot K, Robb WB, Di Fiore F, Guilbert M, Moreau M, Christophe V, Adenis A, Mariette C. Phase II/III multicentre randomised controlled trial evaluating a strategy of primary surgery and adjuvant chemotherapy versus peri-operative chemotherapy for resectable gastric signet ring cell adenocarcinomas - PRODIGE 19 - FFCD1103 - ADCI002. BMC Cancer. 2013 Jun 10;13:281. doi: 1 PMID 23758655
Identifiers
NCT: NCT01717924 · 2011_25 · 2012-000998-24