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

NCT ID: NCT01717924

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2027-11-30

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

Conditions

Signet Ring Cell Gastric Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

peri-operative chemotherapy

Intervention Type: PROCEDURE

Usual treatment strategy for gastric adenocarcinoma

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

Group Type: EXPERIMENTAL

Surgery first

Intervention Type: PROCEDURE

strategy with a surgical procedure first, without the usual peri-operative chemotherapy

Interventions

peri-operative chemotherapy

Usual treatment strategy for gastric adenocarcinoma

Intervention Type: PROCEDURE

Surgery first

strategy with a surgical procedure first, without the usual peri-operative chemotherapy

Intervention Type: PROCEDURE

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federation Francophone de Cancerologie Digestive

OTHER

Sponsor Role: collaborator

UNICANCER

OTHER

Sponsor Role: collaborator

Federation of Research in Surgery (FRENCH)

OTHER

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume mariette, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

FFCD, FNCLCC, FRENCH

Locations

General and digestive surgical department, Claude Huriez Hospital, University Hospital

Lille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Guillaume Piessen, MD,PhD

Role: CONTACT

guillaume.piessen@chru-lille.fr

+33320444407

Facility Contacts

christophe mariette, MD,PhD

Role: primary

christophe.mariette@chru-lille.fr

+33320444407

References

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.

Reference Type: DERIVED

PMID: 23758655 (View on PubMed)

Other Identifiers

2012-000998-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2011_25

Identifier Type: -

Identifier Source: org_study_id