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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000998-24 | EudraCT Number |
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| Name | Class |
|---|---|
| Federation Francophone de Cancerologie Digestive | OTHER |
| UNICANCER | OTHER |
| Federation of Research in Surgery (FRENCH) | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peri-operative chemotherapy | Procedure | Usual treatment strategy for gastric adenocarcinoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients dead in the 2-years | 2 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillaume Piessen, MD,PhD | Contact | +33320444407 | guillaume.piessen@chru-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Guillaume mariette, MD,PhD | FFCD, FNCLCC, FRENCH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General and digestive surgical department, Claude Huriez Hospital, University Hospital | Recruiting | Lille | 59037 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23758655 | Result | 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. |
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| Surgery first | Procedure | strategy with a surgical procedure first, without the usual peri-operative chemotherapy |
|
| 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 |