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

• Sponsor: University Hospital, Lille (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01717924
• Collaborator: Federation Francophone de Cancerologie Digestive (Other), UNICANCER (Other), Federation of Research in Surgery (FRENCH) (Other)
• Enrollment: 314
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 181
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Signet Ring Cell Gastric Adenocarcinoma	Procedure: peri-operative chemotherapy; Procedure: Surgery first	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 314 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Oct 1, 2012
• Anticipated Primary Completion Date: Nov 1, 2027
• Anticipated Study Completion Date: Nov 1, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of patients dead in the 2-years [2 years]

Secondary Outcome Measures

1. Disease-free survival at 2 years [2 years]

2. Disease-free survival at 3 years [3 years]

3. Overall survival at 3 years [3 years]

4. R0 resection rate [within 1 year]

5. grade III/IV toxicity [2 years]

   tolerance will be measured by the rate and grade of chemotherapy's complications

6. post operative morbi-mortality [2 years]

7. Average of patients who benefit from the overall treatment strategy [2 years]

8. quality of life [2 years]

9. emotional status [2 years]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General and digestive surgical department, Claude Huriez Hospital, University Hospital	Lille cedex		France	59037

Sponsors and Collaborators

• University Hospital, Lille
• Federation Francophone de Cancerologie Digestive
• UNICANCER
• Federation of Research in Surgery (FRENCH)

Investigators

• Principal Investigator: Guillaume mariette, MD,PhD, FFCD, FNCLCC, FRENCH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Lille
• ClinicalTrials.gov Identifier: NCT01717924
• Other Study ID Numbers: 2011_25; 2012-000998-24
• First Posted: Oct 31, 2012
• Last Update Posted: Mar 26, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by University Hospital, Lille: Signet ring cell; gastric adenocarcinoma; peri-operative chemotherapy; surgery
• Additional relevant MeSH terms: Adenocarcinoma

Study Results

No Results Posted as of Mar 26, 2021