Multicenter Trial to Evaluate the Strategy of Primary Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma (ADCI002)
This study is currently recruiting participants.
Verified October 2012 by University Hospital, Lille
Sponsor:
University Hospital, Lille
Collaborators:
Federation Francophone de Cancerologie Digestive
UNICANCER
Fédération de Recherche en Chirurgie (FRENCH)
Information provided by (Responsible Party):
Christophe MARIETTE, University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01717924
First received: October 23, 2012
Last updated: October 26, 2012
Last verified: October 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Resectable Signet Ring Cell Gastric Adenocarcinoma |
Procedure: peri-operative chemotherapy Procedure: Surgery first |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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) |
Further study details as provided by University Hospital, Lille:
Primary Outcome Measures:
- Percentage of patients dead in the 2-years [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Disease-free survival at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Disease-free survival at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Overall survival at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- R0 resection rate [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
- Treatment tolerance [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]tolerance will be measured by the rate and grade of chemotherapy's complications
- post operative morbi-mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Average of patients who benefit from the overall treatment strategy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- emotional and cognitive impact of the treatment strategy [ Time Frame: 2 years ] [ Designated as safety issue: No ]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)
| Estimated Enrollment: | 314 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2022 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717924
Contacts
| Contact: christophe Mariette, MD,PhD | +33320444407 | christophe.mariette@chru-lille.fr |
Locations
| France | |
| General and digestive surgical department, Claude Huriez Hospital, University Hospital | Recruiting |
| Lille cedex, France, 59037 | |
| Contact: christophe mariette, MD,PhD +33320444407 christophe.mariette@chru-lille.fr | |
| Principal Investigator: christophe mariette | |
Sponsors and Collaborators
University Hospital, Lille
Federation Francophone de Cancerologie Digestive
UNICANCER
Fédération de Recherche en Chirurgie (FRENCH)
Investigators
| Principal Investigator: | christophe mariette, MD,PhD | FFCD, FNCLCC, FRENCH |
More Information
No publications provided
| Responsible Party: | Christophe MARIETTE, MD, PhD, University Hospital, Lille |
| ClinicalTrials.gov Identifier: | NCT01717924 History of Changes |
| Other Study ID Numbers: | A120566-21 |
| Study First Received: | October 23, 2012 |
| Last Updated: | October 26, 2012 |
| Health Authority: | France: Agence Nationale de Sécurité du Médicament et des produits de santé |
Keywords provided by University Hospital, Lille:
|
Signet ring cell gastric adenocarcinoma peri-operative chemotherapy surgery |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
ClinicalTrials.gov processed this record on June 18, 2013