Evaluation of Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma (ADCI002)

Multicenter Randomized Controlled Trial to Evaluate the Strategy of Primary Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma (ADCI002 Study)

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 Overview

• Status: Recruiting
• Conditions: Signet Ring Cell Gastric Adenocarcinoma
• Intervention / Treatment: Procedure: peri-operative chemotherapy; Procedure: Surgery first

• Study Type: Interventional
• Enrollment (Anticipated): 314
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume Piessen, MD,PhD; Phone Number: +33320444407; Email: guillaume.piessen@chru-lille.fr

Study Locations

• France
  • Lille cedex, France, 59037
    • Recruiting
    • General and digestive surgical department, Claude Huriez Hospital, University Hospital
    • Contact: christophe mariette, MD,PhD; Phone Number: +33320444407; Email: christophe.mariette@chru-lille.fr
    • Principal Investigator: christophe mariette

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: peri-operative chemotherapy; 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	Procedure: peri-operative chemotherapy; Usual treatment strategy for gastric adenocarcinoma
Experimental: surgery first with adjuvant chemotherapy; Surgery first Adjuvant chemotherapy with 3 cycles of Epirubicin/Cisplatin/5FU within 6 and 12 weeks after surgery No neoadjuvant chemotherapy	Procedure: Surgery first; strategy with a surgical procedure first, without the usual peri-operative chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients dead in the 2-years	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
grade III/IV toxicity	tolerance will be measured by the rate and grade of chemotherapy's complications	2 years
post operative morbi-mortality		2 years
Average of patients who benefit from the overall treatment strategy		2 years
quality of life		2 years
emotional status	It will be assessed by quality of life questionnaire(QLQ-C30, QLQ-STO-22,SF-36) and emotional status questionnaire(CES-D, STAI-Y-A, Brief-IPQ, WCC, ICEC-R, CRA)	2 years

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Federation Francophone de Cancerologie Digestive; UNICANCER; Federation of Research in Surgery (FRENCH)
• Investigators: Principal Investigator: Guillaume mariette, MD,PhD, FFCD, FNCLCC, FRENCH

Publications and helpful links

General 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: 10.1186/1471-2407-13-281.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Anticipated): November 1, 2027
• Study Completion (Anticipated): November 1, 2027

Study Registration Dates

• First Submitted: October 23, 2012
• First Submitted That Met QC Criteria: October 26, 2012
• First Posted (Estimate): October 31, 2012

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: surgery; gastric adenocarcinoma; Signet ring cell; peri-operative chemotherapy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: 2011_25; 2012-000998-24 (EudraCT Number)