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

Primary Purpose

Signet Ring Cell Gastric Adenocarcinoma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
peri-operative chemotherapy
Surgery first
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Signet Ring Cell Gastric Adenocarcinoma focused on measuring Signet ring cell, gastric adenocarcinoma, peri-operative chemotherapy, surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

peri-operative chemotherapy

surgery first with adjuvant chemotherapy

Arm Description

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 Adjuvant chemotherapy with 3 cycles of Epirubicin/Cisplatin/5FU within 6 and 12 weeks after surgery No neoadjuvant chemotherapy

Outcomes

Primary Outcome Measures

Percentage of patients dead in the 2-years

Secondary Outcome Measures

Disease-free survival at 2 years
Disease-free survival at 3 years
Overall survival at 3 years
R0 resection rate
grade III/IV toxicity
tolerance will be measured by the rate and grade of chemotherapy's complications
post operative morbi-mortality
Average of patients who benefit from the overall treatment strategy
quality of life
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)

Full Information

First Posted
October 23, 2012
Last Updated
January 25, 2023
Sponsor
University Hospital, Lille
Collaborators
Federation Francophone de Cancerologie Digestive, UNICANCER, Federation of Research in Surgery (FRENCH)
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1. Study Identification

Unique Protocol Identification Number
NCT01717924
Brief Title
Evaluation of Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma
Acronym
ADCI002
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2012 (Actual)
Primary Completion Date
November 2027 (Anticipated)
Study Completion Date
November 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Federation Francophone de Cancerologie Digestive, UNICANCER, Federation of Research in Surgery (FRENCH)

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Signet Ring Cell Gastric Adenocarcinoma
Keywords
Signet ring cell, gastric adenocarcinoma, peri-operative chemotherapy, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
314 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
peri-operative chemotherapy
Arm Type
Active Comparator
Arm Description
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
Arm Title
surgery first with adjuvant chemotherapy
Arm Type
Experimental
Arm Description
Surgery first Adjuvant chemotherapy with 3 cycles of Epirubicin/Cisplatin/5FU within 6 and 12 weeks after surgery No neoadjuvant chemotherapy
Intervention Type
Procedure
Intervention Name(s)
peri-operative chemotherapy
Intervention Description
Usual treatment strategy for gastric adenocarcinoma
Intervention Type
Procedure
Intervention Name(s)
Surgery first
Intervention Description
strategy with a surgical procedure first, without the usual peri-operative chemotherapy
Primary Outcome Measure Information:
Title
Percentage of patients dead in the 2-years
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Disease-free survival at 2 years
Time Frame
2 years
Title
Disease-free survival at 3 years
Time Frame
3 years
Title
Overall survival at 3 years
Time Frame
3 years
Title
R0 resection rate
Time Frame
within 1 year
Title
grade III/IV toxicity
Description
tolerance will be measured by the rate and grade of chemotherapy's complications
Time Frame
2 years
Title
post operative morbi-mortality
Time Frame
2 years
Title
Average of patients who benefit from the overall treatment strategy
Time Frame
2 years
Title
quality of life
Time Frame
2 years
Title
emotional status
Description
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)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume Piessen, MD,PhD
Phone
+33320444407
Email
guillaume.piessen@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume mariette, MD,PhD
Organizational Affiliation
FFCD, FNCLCC, FRENCH
Official's Role
Principal Investigator
Facility Information:
Facility Name
General and digestive surgical department, Claude Huriez Hospital, University Hospital
City
Lille cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
christophe mariette, MD,PhD
Phone
+33320444407
Email
christophe.mariette@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
christophe mariette

12. IPD Sharing Statement

Citations:
PubMed Identifier
23758655
Citation
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.
Results Reference
derived

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

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