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Gastric AdenocarcinomaPhase 3SURGIGASTNCT03042169

Surgical Resection Plus Chemotherapy Versus Chemotherapy Alone in Oligometastatic Stage IV Gastric Cancer

A Phase 3 study testing Preoperative Chemotherapy, Surgery and Postoperative chemotherapy in people with Gastric Adenocarcinoma, run by University Hospital, Lille at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Surgical resection of the primary tumour and treatment of the metastatic site in oligometastatic stage IV metastatic gastric adenocarcinoma enhances survival and improves quality of life with acceptable postoperative morbidity and mortality in a selected group of operable patients with only one metastatic site that… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Gastric Adenocarcinoma
What is being tested?
Preoperative Chemotherapy, Surgery and Postoperative chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteFrance
Study dates
25 Aug 2021to 28 Aug 2024
Phase
Phase 3
Are there results?
None posted in the registry

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

  • 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)
  • 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
  • Locally resectable primary tumour and oligometastatic lesion accessible to surgical resection or local ablation procedure
  • 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:
  • 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
  • Other acceptable limited metastatic lesions:
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  • 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
  • ECOG performance status 0 or 1
  • Man or women aged ≥ 18 years and ≤ 80 years
  • For surgery and/or chemotherapy, adequate cardiac, respiratory, bone marrow, renal and liver functions according to usual practices standards
  • Ability to understand and complete quality of life questionnaires (EORTC QLQ C30 and QLQ STO 22)
  • Negative pregnancy test (urine or serum) performed prior to start the study in for females of childbearing potential with reproductive potential
  • 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
  • Patient covered by a government Health Insurance
  • Patient who provides a signed written Inform Consent

Who cannot join

  • Other histological subtype than adenocarcinoma
  • ECOG performance status ≥ 2 2,3 or 4
  • Diffuse peritoneal carcinomatosis (PCI ≥ 7) or significant ascites
  • Metastatic disease involving more than one solid organ metastatic site
  • 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
  • Contraindication to chemotherapy or surgery according to the multidisciplinary team decision
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  • Second uncontrolled malignant tumour
  • Proximal (junctionnal) tumour growth across the Z-line requiring additional trans thoracic oesophageal resectionµ
  • Emergency surgery due to bleeding or perforation
  • Age > 80 years
  • Weight loss ≥ 20% persisting despite appropriate nutritional assistance
  • Severe comorbid conditions that may jeopardize short term outcomes (e.g. cardiac, respiratory, bone marrow, renal or liver insufficiency...)
  • Dihydropyrimidine dehydrogenase Deficiency (DPD)
  • Women who are pregnant or breastfeeding
  • Patients in emergency situations
  • Patients kept in detention and/or under legal protection under psychiatric care and/or interned in a social or psychiatric institution
  • Adult patient under legal protection or in the incapacity to express his/her consent
  • Patient not covered by a health insurance system

Trial locations and contacts

1 site in 1 country.

France1 site

  • Ico - Site Gauducheau - St Herblain

    Saint-Herblain

Other trials in France

About this study

Official title: Surgical Resection Plus Chemotherapy Versus Chemotherapy Alone in Oligometastatic Stage IV Gastric Cancer - a Multicenter, Prospective, Open-labeled, Two-armed, Randomized, Controlled Phase III Trial

Surgical resection of the primary tumour and treatment of the metastatic site in oligometastatic stage IV metastatic gastric adenocarcinoma enhances survival and improves quality of life with acceptable postoperative morbidity and mortality in a selected group of operable patients with only one metastatic site that does not progress under chemotherapy.

Being tested
Preoperative Chemotherapy, Surgery, Postoperative chemotherapy
Keywords
Stage IV gastric cancer, palliative surgery, chemotherapy, survival, quality of life
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preoperative ChemotherapyDrug

    Standard chemotherapy regiments according to risk of recurrence

  • SurgeryProcedure or surgery

    Also called surgical removal of the primary tumour followed by chemotherapy

    the surgical treatment will undergo gastrectomy between D1 and D30 after randomization.

  • Postoperative chemotherapyDrug

    Chemotherapy should be restarted between D1 and D30 post-randomization

Study groups in NCT03042169
Study groupRoleWhat they receive
continuation of chemotherapyActive comparatorPatients assigned to arm A will continue to receive the same chemotherapy regimen they received before randomization. Chemotherapy should be restarted between D1 and D30 after randomization. In case of poor tolerance to the induction chemotherapy, alternative chemotherapy regimen might be discussed, according to local standards and national guidelines (www.tncd.org).
Receives: Drug: Preoperative Chemotherapy; Drug: Postoperative chemotherapy
surgical removal of the primary tumour and treatment of the metastatic site followed by chemotherapyExperimentalPatients assigned to arm B will undergo gastrectomy (subtotal or total according to the location of the primary tumour) between D1 and D30 after randomization. Subtotal gastrectomy is recommended if it allows a complete resection of the primary tumour to limit postoperative morbidity in such metastatic situations, based on the results of REGATTA
Receives: Procedure: Surgery; Drug: Postoperative chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: Between the date of randomisation to the date of death whatever the cause,assessed up to 2 years

Secondary outcomes (8)

  1. EORTC QLQ C30

    Measured: Every 3 months during 2 years

  2. QLQ STO 22 questionnaires

    Measured: Every 3 months during 2 years

  3. Progression free survival

    Measured: from randomisation to the date of documented progression according to RECIST or death whatever the cause,assessed up to 2 years

  4. Surgery related postoperative morbidity-mortality

    grade III, IV and V and complications according to the Dindo-Clavien classification

    Measured: within 30 days and 90 days

  5. Specific complications related to treatment of the metastatic site

    grade III, IV and V complications according to the Dindo-Clavien classification for surgical treatment strategy and grade III, IV and V adverse reactions according to the NCI-CTCAE v5.0 for other treatment strategies (i.e. HIPEC, radiofrequency, microwave and radiotherapy).

    Measured: within 30 days and 90 days post-treatment

  6. Chemotherapy related toxicities : grade III, IV and V toxicities according to the NCI-CTCAE v5.0

    Measured: Every 3 months during 2 years]

  7. Overall cumulative duration of hospitalisation

    calculated in days from randomization

    Measured: throughout the duration of the study, during 2 years

  8. Number of interventional palliative procedures per patient

    mean per patient from randomization

    Measured: throughout the duration of the study, during 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2017 (estimated)
  2. Study start25 Aug 2021
  3. Primary completion28 Aug 2024
  4. Study completion28 Aug 2024

Why it stopped: default inclusion

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03042169
Sponsor's protocol ID
2015_07
Other IDs
2016-A01265-46
Acronym
SURGIGAST
Status last verified
Dec 2025
First submitted
31 Jan 2017
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Preoperative Chemotherapy, Surgery and Postoperative chemotherapy in people with 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 20 inclusion and 18 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: stopped early, as of the sponsor's last update on 23 Dec 2025. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: default inclusion). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Between the date of randomisation to the date of death whatever the cause,assessed up to 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 NCT03042169.

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 23 Dec 2025.

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