Signet Ring Cell Gastric AdenocarcinomaADCI002NCT01717924
Evaluation of Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma
A study testing peri-operative chemotherapy and Surgery first in people with Signet Ring Cell Gastric Adenocarcinoma, run by University Hospital, Lille at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Signet Ring Cell Gastric Adenocarcinoma
- What is being tested?
- peri-operative chemotherapy and Surgery first
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
General and digestive surgical department, Claude Huriez Hospital, University Hospital
Lille, 59037
christophe mariette, MD,PhD, +33320444407, christophe.mariette@chru-lille.fr
christophe mariette
About this study
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)
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
- Conditions
- Signet Ring Cell Gastric Adenocarcinoma
- Being tested
- peri-operative chemotherapy, Surgery first
- Keywords
- Signet ring cell, gastric adenocarcinoma, peri-operative chemotherapy, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peri-operative chemotherapyProcedure or surgery
Usual treatment strategy for gastric adenocarcinoma
Surgery firstProcedure or surgery
strategy with a surgical procedure first, without the usual peri-operative chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Surgery first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients dead in the 2-years
Measured: 2 years
Secondary outcomes (9)
Disease-free survival at 2 years
Measured: 2 years
Disease-free survival at 3 years
Measured: 3 years
Overall survival at 3 years
Measured: 3 years
R0 resection rate
Measured: within 1 year
grade III/IV toxicity
tolerance will be measured by the rate and grade of chemotherapy's complications
Measured: 2 years
post operative morbi-mortality
Measured: 2 years
Average of patients who benefit from the overall treatment strategy
Measured: 2 years
quality of life
Measured: 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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Signet Ring Cell Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Federation Francophone de Cancerologie Digestive, UNICANCER, Federation of Research in Surgery (FRENCH)
- Responsible party
- Sponsor
- Investigators
- Guillaume mariette, MD,PhD, Principal investigator, FFCD, FNCLCC, FRENCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717924
- Sponsor's protocol ID
- 2011_25
- Other IDs
- 2012-000998-24
- Acronym
- ADCI002
- Status last verified
- Jan 2023
- First submitted
- 23 Oct 2012
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23758655
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01717924
- Acronym / sponsor ID
- ADCI002 / 2011_25
- Conditions
- Signet Ring Cell Gastric Adenocarcinoma
- Keywords
- Signet ring cell, gastric adenocarcinoma, peri-operative chemotherapy, surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Federation Francophone de Cancerologie Digestive, UNICANCER, Federation of Research in Surgery (FRENCH)
- Study start
- Oct 2012 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| peri-operative chemotherapy | Active comparator | Procedure: peri-operative chemotherapyNeoadjuvant 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 | Procedure: Surgery firstSurgery first Adjuvant chemotherapy with 3 cycles of Epirubicin/Cisplatin/5FU within 6 and 12 weeks after surgery No neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peri-operative chemotherapyUsual treatment strategy for gastric adenocarcinoma | Procedure or surgery | peri-operative chemotherapy |
| Surgery firststrategy with a surgical procedure first, without the usual peri-operative chemotherapy | Procedure or surgery | surgery first with adjuvant chemotherapy |
Primary outcome
Percentage of patients dead in the 2-years
Time frame: 2 years
9 secondary outcomes
Disease-free survival at 2 years
Time frame: 2 years
Disease-free survival at 3 years
Time frame: 3 years
Overall survival at 3 years
Time frame: 3 years
R0 resection rate
Time frame: within 1 year
grade III/IV toxicity
Time frame: 2 years
post operative morbi-mortality
Time frame: 2 years
Average of patients who benefit from the overall treatment strategy
Time frame: 2 years
quality of life
Time frame: 2 years
emotional status
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 23758655Piessen 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.
Related trials for Signet Ring Cell Gastric Adenocarcinoma
Not yet recruitingPhase 2
Efficacy and Safety of AK112 Combined Chemotherapy as Neoadjuvant Treatment for Signet Ring Cell-containing G/GEJ Adenocarcinoma
Gastric or Gastroesophageal Junction Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume mariette, MD,PhD principal investigator
FFCD, FNCLCC, FRENCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peri-operative chemotherapy and Surgery first in people with Signet Ring Cell Gastric Adenocarcinoma, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Piessen, MD,PhD (+33320444407, guillaume.piessen@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients dead in the 2-years (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01717924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.