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Stomach cancer surgery combo trial fizzles: only 6 patients enrolled

NCT ID NCT03042169

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding surgery to chemotherapy helps people with stage IV stomach cancer that has spread to only one other area. The goal was to see if surgery could improve survival and quality of life. However, the trial was stopped early after enrolling only 6 participants, so no strong conclusions can be drawn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
chemotherapy and surgery
What this could lead to
If it had succeeded, this could have shown that surgery plus chemotherapy improves survival for some patients with stage IV gastric cancer that has spread to only one other site.
What could go wrong
The trial was terminated early with only 6 participants, so results are very limited. It is unclear if the approach is truly beneficial, and surgery carries risks like complications and recovery time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

6 people

The number who actually took part.

Started

Aug 2021

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Primary diagnosis of UICC stage IV gastric adenocarcinoma with histological proof of the primary tumour (with HER2 status, PCC histology and MMR status available and SRC histology available on anatomo-pathology reports) 2. Without any form of previous treatment (surgery and / or chemotherapy and / or radiotherapy) for this diagnosis other than local endoscopic treatment. Note : 3. pPatients having received first line chemotherapy for at least 2 months and completing inclusion/exclusion criteria can be included in the study at V2 3. Locally resectable primary tumour and oligometastatic lesion accessible to surgical resection or local ablation procedure 4. Oligometastatic lesion : Retro-Peritoneal Lymph Node Metastases (RPLM) and/or another metastatic lesion on only one organ (solid organ, lymph node or limited localised peritoneal carcinomatosis with PCI \< 7) according to the following non-exhaustive list of definitions: 1. RPLM: para-aortal, intra-aorto-caval, para-pancreatic or mesenteric lymph node(s). Note: in duodenum invading gastric cancer, retro-pancreatic nodes are not regarded as metastatic sites 2. Other acceptable limited metastatic lesions: * Localized potentially operable peritoneal carcinomatosis: PCI \< 7 including uni or bilateral Krukenberg tumors (ovarian metastases) * Liver: maximum of 5 metastatic lesions that are potentially resectable * Lung: unilateral involvement, potentially resectable * Uni- or bilateral adrenal gland metastases * Extra-abdominal lymph node metastases such as supraclavicular or cervical lymph node involvement * Localized bone involvement (defined as being within one radiation field) Notes: 1. Patients with more than one metastatic site in only one organ are eligible. 2. In case of doubt for considering whether a metastatic site is limited or not, please submit the case with relevant anonymised information to the medical coordinator of the study for approval. 6. Only one solid organ metastatic site (hepatic, lung, adrenal gland, bone, brain...). Patients with more than one metastatic lesion in only one organ are eligible 5. ECOG performance status 0 or 1 6. Man or women aged ≥ 18 years and ≤ 80 years 7. For surgery and/or chemotherapy, adequate cardiac, respiratory, bone marrow, renal and liver functions according to usual practices standards 8. Ability to understand and complete quality of life questionnaires (EORTC QLQ C30 and QLQ STO 22) 9. Negative pregnancy test (urine or serum) performed prior to start the study in for females of childbearing potential with reproductive potential 10. Male and female patients of child-bearing reproductive potential must agree to us an effective method of contraception approved by the investigator during the study and for a minimum of 6 months after the end of study treatment 11. Patient covered by a government Health Insurance 12. Patient who provides a signed written Inform Consent Exclusion Criteria: 1. Other histological subtype than adenocarcinoma 2. ECOG performance status ≥ 2 2,3 or 4 3. Diffuse peritoneal carcinomatosis (PCI ≥ 7) or significant ascites 4. Metastatic disease involving more than one solid organ metastatic site 5. Primary tumor irresectability and/or metastatic lesion not accessible for resection or local ablation procedure or need for multi-visceral resection with expected high complication rate 6. Contraindication to chemotherapy or surgery according to the multidisciplinary team decision 7. Second uncontrolled malignant tumour 8. Proximal (junctionnal) tumour growth across the Z-line requiring additional trans thoracic oesophageal resectionµ 9. Emergency surgery due to bleeding or perforation 10. Age \> 80 years 11. Weight loss ≥ 20% persisting despite appropriate nutritional assistance 12. Severe comorbid conditions that may jeopardize short term outcomes (e.g. cardiac, respiratory, bone marrow, renal or liver insufficiency...) 13. Dihydropyrimidine dehydrogenase Deficiency (DPD) 14. Women who are pregnant or breastfeeding 15. Patients in emergency situations 16. Patients kept in detention and/or under legal protection under psychiatric care and/or interned in a social or psychiatric institution 17. Adult patient under legal protection or in the incapacity to express his/her consent 18. Patient not covered by a health insurance system

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Ico - Site Gauducheau - St Herblain

    Saint-Herblain, France

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Other studies related to the condition(s) this trial covers.