Comparing surgery and chemotherapy for treating a specific type of stomach cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness of primary surgery versus primary chemotherapy followed by surgery in patients with resectable signet ring cell gastric adenocarcinoma. It is a multicenter, randomized controlled trial designed to determine which approach yields better outcomes for patients. Participants will be assigned to either receive surgery first or undergo chemotherapy before surgery. The study aims to provide insights into the optimal treatment strategy for this rare and aggressive form of gastric cancer.

Why it matters

Who can join: the full rules

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

Where it's running

• General and digestive surgical department, Claude Huriez Hospital, University Hospital
  Lille, France Recruiting

Study contacts

• Principal investigator: Guillaume mariette, MD,PhD — Ffcd, Fnclcc, French
• Study coordinator: Guillaume Piessen, MD,PhD
• Email: guillaume.piessen@chru-lille.fr
• Phone: +33320444407

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Molecular and immune profiling of lung signet ring cell carcinoma in Chinese patients

  This project will see if genetic and immune profiling of untreated Chinese patients with lung signet ring cell carcinoma can find molecular markers and immune subtypes, and patients with ALK fusions and specific immune patterns may receive targeted TKI treatment.

  Recruiting First People's Hospital of Hangzhou · Hangzhou, Zhejiang · NCT07207278

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.