NCT01717924

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Oct 2012Nov 2027

Study Start

First participant enrolled

October 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 31, 2012

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

15.1 years

First QC Date

October 23, 2012

Last Update Submit

January 25, 2023

Conditions

Signet Ring Cell Gastric Adenocarcinoma

Keywords

Signet ring cellgastric adenocarcinomaperi-operative chemotherapysurgery

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients dead in the 2-years

    2 years

Secondary Outcomes (9)

  • Disease-free survival at 2 years

    2 years

  • Disease-free survival at 3 years

    3 years

  • Overall survival at 3 years

    3 years

  • R0 resection rate

    within 1 year

  • grade III/IV toxicity

    2 years

  • +4 more secondary outcomes

Study Arms (2)

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

Procedure: peri-operative chemotherapy

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

Procedure: Surgery first

Interventions

peri-operative chemotherapyPROCEDURE

Usual treatment strategy for gastric adenocarcinoma

peri-operative chemotherapy
Surgery firstPROCEDURE

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

surgery first with adjuvant chemotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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
  • 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
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lille, 59037, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23758655DERIVED

Study Officials

  • Guillaume mariette, MD,PhD

    FFCD, FNCLCC, FRENCH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume Piessen, MD,PhD

CONTACT

+33320444407guillaume.piessen@chru-lille.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2012

First Posted

October 31, 2012

Study Start

October 1, 2012

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations

FR(1)