Gastric CancerSTOMACHNCT02130726
Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy
A study testing Minimally-invasive gastrectomy and Open Gastrectomy in people with Gastric Cancer, run by Amsterdam UMC, location VUmc at 8 sites in 4 countries.
Trial summary
Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less peri-operative blood loss, faster patient recovery and shorter hospital stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Minimally-invasive gastrectomy and Open Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Dec 2014to Jun 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal to or above 18 years
- Primary adenocarcinoma of stomach, indication for total gastrectomy with curative intent.
- Neoadjuvant therapy (epirubicin, cisplatin, capecitabine)
- Surgical resectable (T1-3, N0-1, M0)
- Informed consent
Who cannot join
- Previous or coexisting cancer
- Previous surgery of the stomach
- ASA classification (American Society of Anaesthesiologists) score 4 or higher
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Spain4 sites
Hospital universitari Basurto
Bilbao
Hospital Jerez de la Frontera
Cadiz
Hospital Universitario de Josep Trueta
Girona
Hospital Universitario del Sureste de Madrid
Madrid
Netherlands2 sites
VU Medical Center
Amsterdam, NLNH, 1081HV
Academic Medical Centre
Amsterdam, North Holland, 1105AZ
About this study
Official title: The STOMACH Trial: Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy
Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less peri-operative blood loss, faster patient recovery and shorter hospital stay. All while maintaining similar results with regard to tumour resection margin and oncological survival. In gastric cancer the role of laparoscopic surgery remains unclear.
Current recommended treatment for gastric cancer consists of radical resection of the stomach, combined with lymfadenectomy. The extent of lymfadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, It is imperative that a new surgical technique should be non-inferior with regard to radicality and lymph node yield.
Read more
Preliminary studies show promising results for laparoscopic gastrectomy, but the number of studies is small and due to lower incidence of gastric cancer in the West they are often underpowered. A prospective randomised clinical trial is indicated in order to establish the optimal surgical technique in gastric cancer: open versus minimally invasive gastrectomy.
Results of the STOMACH trial will further aid in determining the optimal surgical technique in patients with gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- Minimally-invasive gastrectomy, Open Gastrectomy
- Keywords
- Gastric cancer, Minimally-invasive, Oncological quality of resection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally-invasive gastrectomyProcedure or surgery
Also called laparoscopic gastrectomy
Patients allocated to the 'Minimally-invasive gastrectomy' arm will receive total gastrectomy via laparoscopy.
Open GastrectomyProcedure or surgery
Also called Conventional Gastrectomy
patients allocated to the 'Open gastrectomy' group will receive total gastrectomy via laparotomy
| Study group | Role | What they receive |
|---|---|---|
| Minimally-invasive Gastrectomy | Experimental | Patients allocated to the 'Minimally-invasive Gastrectomy' group will undergo minimally-invasive/laparoscopic total gastrectomy. If, during surgery, laparoscopic resection does not seem feasible, the procedure may be converted to an open one. Receives: Procedure: Minimally-invasive gastrectomy |
| Open Gastrectomy | Active comparator | Patients allocated to the 'Open Gastrectomy' group will receive total resection of the stomach via laparotomy. This group is considered the control group Receives: Procedure: Open Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of lymph node dissection
The extent of lymph node dissection in treatment of gastric cancer is considered a prognostic marker for postoperative survival and disease-free survival. Before implementation of a new surgical technique, it is imperative that this technique is non-inferior with regard to the extent of lymph node dissection. Measures will include the number of resected lymph nodes and the number of resected lymph node stations.
Measured: two weeks
Secondary outcomes (8)
Postoperative complications
Postoperative complications after major abdominal surgery, such as gastric resection, lead to increased morbidity and mortality. A new surgical technique should be non-inferior or even improve outcomes with regard to postoperative complications. Complications will be graded according to the Clavien-Dindo classification, which grades complications with regard to necessary treatment for this complication. Also Long-term complications, such as hernia cicatricialis will be monitored.
Measured: Postoperatively with follow-up to one year
Quality of Life
Patient Related Outcome Measures (PROMs) are of increasing importance. A new surgical technique should aim at improved PROMs, which will be measured with several questionnaires. The SF-36 and GIQLI questionnaires.
Measured: 1 and 5 days postoperatively, 3 months, 6 months and 12 months
Duration of hospital admission
Minimally-invasive surgery is associated with faster patient recovery and shorter duration of hospital admission. The number of days of hospital admission will be recorded. Readmission will be registered separately.
Measured: during admission, average 2 weeks
Duration of Intensive Care admission
Minimally-invasive surgery is associated with faster patient recovery, therefore we expect the number of days spent on the intensive care unit to be less in this group.
Measured: During submission, average 2 days
Peri-operative blood loss
Minimally-invasive surgery is associated with less peri-operative blood loss. Blood loss will be measured in milliliters and average blood loss will be compared to the conventional 'open' group.
Measured: during surgery, 1 day
Duration of Surgery
Due to the techniques associated with minimally-invasive surgery the average procedure takes longer to complete. The duration of the procedure will be registered in minutes.
Measured: Peri-operatively, 1 day
Cost-effectiveness
Cost-effectiveness will be measured based on duration and equipment necessary for surgery, admission duration, ICU admission and reinterventions.
Measured: from surgery to one year follow-up
Disease-free survival
In order to further assess oncological feasibility of minimally-invasive gastrectomy disease-free survival will be monitored up to 5 years postoperatively. Patients are informed, when they enter the study, that they can be contacted for additional information up to 5 years postoperatively.
Measured: up to 5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Nuts Ohra
- Responsible party
- Principal investigator, J. Straatman, Amsterdam UMC, location VUmc
- Investigators
- D.L. van der Peet, MD, PhD, Principal investigator, VU Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130726
- Sponsor's protocol ID
- STOMACH trial
- Acronym
- STOMACH
- Status last verified
- Jul 2019
- First submitted
- 28 Apr 2014
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van der Wielen N, Daams F, Rosati R, Parise P, Weitz J, Reissfelder C, Del Val ID, Loureiro C, Parada-Gonzalez P, Pintos-Martinez E, Vallejo FM, Achirica CM, Sanchez-Pernaute A, Campos AR, Bonavina L, Asti ELG, Poza AA, Gilsanz C, Nilsson M, Lindblad M, Gisbertz SS, van Berge Henegouwen MI, Romario UF, De Pascale S, Akhtar K, Cuesta MA, van der Peet DL, Straatman J. Three-year survival and distribution of lymph node metastases in gastric cancer following neoadjuvant chemotherapy: results from a European randomized clinical trial. Surg Endosc. 2023 Sep;37(9):7317-7324. doi: 10.1007/s00464-023-10278-5. Epub 2023 Jul 19.
PubMed 37468751Straatman J, van der Wielen N, Cuesta MA, Gisbertz SS, Hartemink KJ, Alonso Poza A, Weitz J, Mateo Vallejo F, Ahktar K, Diez Del Val I, Roig Garcia J, van der Peet DL. Surgical techniques, open versus minimally invasive gastrectomy after chemotherapy (STOMACH trial): study protocol for a randomized controlled trial. Trials. 2015 Mar 27;16:123. doi: 10.1186/s13063-015-0638-9.
PubMed 25873249
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STOMACH Trial: Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy
- ClinicalTrials.gov ID
- NCT02130726
- Acronym / sponsor ID
- STOMACH / STOMACH trial
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Minimally-invasive, Oncological quality of resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Stichting Nuts Ohra
- Study start
- Dec 2014
- Primary completion
- Mar 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 5 May 2014 (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.
Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less peri-operative blood loss, faster patient recovery and shorter hospital stay. All while maintaining similar results with regard to tumour resection margin and oncological survival. In gastric cancer the role of laparoscopic surgery remains unclear.
Current recommended treatment for gastric cancer consists of radical resection of the stomach, combined with lymfadenectomy. The extent of lymfadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, It is imperative that a new surgical technique should be non-inferior with regard to radicality and lymph node yield.
Preliminary studies show promising results for laparoscopic gastrectomy, but the number of studies is small and due to lower incidence of gastric cancer in the West they are often underpowered. A prospective randomised clinical trial is indicated in order to establish the optimal surgical technique in gastric cancer: open versus minimally invasive gastrectomy.
Results of the STOMACH trial will further aid in determining the optimal surgical technique in patients with gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally-invasive Gastrectomy | Experimental | Procedure: Minimally-invasive gastrectomyPatients allocated to the 'Minimally-invasive Gastrectomy' group will undergo minimally-invasive/laparoscopic total gastrectomy. If, during surgery, laparoscopic resection does not seem feasible, the procedure may be converted to an open one. |
| Open Gastrectomy | Active comparator | Procedure: Open GastrectomyPatients allocated to the 'Open Gastrectomy' group will receive total resection of the stomach via laparotomy. This group is considered the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age equal to or above 18 years
- Primary adenocarcinoma of stomach, indication for total gastrectomy with curative intent.
- Neoadjuvant therapy (epirubicin, cisplatin, capecitabine)
- Surgical resectable (T1-3, N0-1, M0)
- Informed consent
Key exclusion criteria (3 listed)
- Previous or coexisting cancer
- Previous surgery of the stomach
- ASA classification (American Society of Anaesthesiologists) score 4 or higher
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 |
|---|---|---|
| Minimally-invasive gastrectomyAlso: laparoscopic gastrectomyPatients allocated to the 'Minimally-invasive gastrectomy' arm will receive total gastrectomy via laparoscopy. | Procedure or surgery | Minimally-invasive Gastrectomy |
| Open GastrectomyAlso: Conventional Gastrectomypatients allocated to the 'Open gastrectomy' group will receive total gastrectomy via laparotomy | Procedure or surgery | Open Gastrectomy |
Primary outcome
Extent of lymph node dissection
Time frame: two weeks
The extent of lymph node dissection in treatment of gastric cancer is considered a prognostic marker for postoperative survival and disease-free survival. Before implementation of a new surgical technique, it is imperative that this technique is non-inferior with regard to the extent of lymph node dissection. Measures will include the number of resected lymph nodes and the number of resected lymph node stations.
8 secondary outcomes
Postoperative complications
Time frame: Postoperatively with follow-up to one year
Quality of Life
Time frame: 1 and 5 days postoperatively, 3 months, 6 months and 12 months
Duration of hospital admission
Time frame: during admission, average 2 weeks
Duration of Intensive Care admission
Time frame: During submission, average 2 days
Peri-operative blood loss
Time frame: during surgery, 1 day
Duration of Surgery
Time frame: Peri-operatively, 1 day
Cost-effectiveness
Time frame: from surgery to one year follow-up
Disease-free survival
Time frame: up to 5 years postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Derived from this study: PubMed 37468751van der Wielen N, Daams F, Rosati R, Parise P, Weitz J, Reissfelder C, Del Val ID, Loureiro C, Parada-Gonzalez P, Pintos-Martinez E, Vallejo FM, Achirica CM, Sanchez-Pernaute A, Campos AR, Bonavina L, Asti ELG, Poza AA, Gilsanz C, Nilsson M, Lindblad M, Gisbertz SS, van Berge Henegouwen MI, Romario UF, De Pascale S, Akhtar K, Cuesta MA, van der Peet DL, Straatman J. Three-year survival and distribution of lymph node metastases in gastric cancer following neoadjuvant chemotherapy: results from a European randomized clinical trial. Surg Endosc. 2023 Sep;37(9):7317-7324. doi: 10.1007/s00464-023-10278-5. Epub 2023 Jul 19.
- Derived from this study: PubMed 25873249Straatman J, van der Wielen N, Cuesta MA, Gisbertz SS, Hartemink KJ, Alonso Poza A, Weitz J, Mateo Vallejo F, Ahktar K, Diez Del Val I, Roig Garcia J, van der Peet DL. Surgical techniques, open versus minimally invasive gastrectomy after chemotherapy (STOMACH trial): study protocol for a randomized controlled trial. Trials. 2015 Mar 27;16:123. doi: 10.1186/s13063-015-0638-9.
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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. This study is not recruiting at the moment.
D.L. van der Peet, MD, PhD principal investigator
VU Medisch Centrum
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally-invasive gastrectomy and Open Gastrectomy in people with Gastric Cancer, run by Amsterdam UMC, location VUmc at 8 sites in 4 countries.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Netherlands, Germany, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Extent of lymph node dissection (time frame: two weeks). 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 NCT02130726, which also lists 2 linked publications.
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 17 Jul 2019.