Gastric CancerNCT03001726
To Observe the Efficacy and Safety by Comparing Chemotherapy(Docetaxel, Oxaliplatin Plus S1 ) Followed With Radical Resection Versus Chemotherapy Alone in Advanced Gastric Cancer With Single Non-curable Factor.
An observational study of Gastric Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Investigators assessed the effectiveness of conversional gastrectomy compared with chemotherapy alone following docetaxel, oxalipaltin and S1 therapy for advanced gastric cancer with a single non-curable factor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Gastrectomy, oxaliplatin and S1
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 2023
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical diagnosis of gastric cancer with a single non-curable factor
Who may be able to join
- Clinical diagnosis of gastric cancer with a single non-curable factor
- A single non-curable factor was defined as hepatic metastasis (H1; two to four lesions of maximum diameter ≤5 cm and minimum diameter ≥1 cm); peritoneal metastasis (P1) in the diaphragm or peritoneum caudal to the transverse colon without massive ascites or intestinal obstruction; positive cytology (CY1) when the cancer cells were found in the peritoneal washing; para-aortic lymph node (PAN) metastasis above the coeliac axis or below the inferior mesenteric artery (lymph node 16a1/b2 of maximum diameter ≥1 cm), or both; or ovary implant metastasis for one site or two.
Who cannot join
- Patients who can have radical resection.
- Patietns who have more than one metastasis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastrectomy Plus Chemotherapy Versus Chemotherapy Alone for Advanced Gastric Cancer With a Single Non-curable Factor
Investigators assessed the effectiveness of conversional gastrectomy compared with chemotherapy alone following docetaxel, oxalipaltin and S1 therapy for advanced gastric cancer with a single non-curable factor.
Read the detailed description
Palliative chemotherapy is still the standard of care for incurable advanced gastric cancer. Several retrospective, single institutional studies have shown that the addition of gastrectomy to chemotherapy might improve patient survival among patients with metastatic gastric cancer with a single non-curable factor. However, REGATTA trial, a phase 3, randomized controlled trial, concluded an opposite conclusion that gastrectomy followed by chemotherapy did not show any survival benefit compared with chemotherapy alone in advanced gastric cancer with a single non-curable factor. Interestingly, five patients initially assigned to chemotherapy alone in the study had got survival benefit form gastrectomy with curative intent because of complete disappear of all non-curable factors during chemotherapy. This finding raised the question as to conversional radical surgery following upfront chemotherapy could be a possible treatment option. We assessed the effectiveness of conversional radical surgery following docetaxel, oxalipaltin and S1 therapy for advanced gastric cancer with a single non-curable factor.
- Conditions
- Gastric Cancer
- Being tested
- Gastrectomy, oxaliplatin, S1, Docetaxel
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastrectomyProcedure or surgery
In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.
oxaliplatinDrug
Also called Eloxatin
oxaliplatin 100 mg/m2
S1Drug
Also called tegafur
S1 40mg/m2
DocetaxelDrug
Also called Taxotere
docetaxel 40 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Gastrectomy plus chemotherapy | In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location. Receives: Procedure: Gastrectomy; Drug: oxaliplatin; Drug: S1; Drug: Docetaxel | |
| chemotherapy alone | Patients received chemotherapy alone.All patients received oral S1 80 mg/m2 per day (80-120 mg/day total dose depending on the patient's body surface area as follows: <1.25 m2, 80 mg; 1.25-1.5 m2, 100 mg; and >1.5 m2, 120 mg) on days 1-21 of every 3-week cycle, oxaliplatin 100 mg/m2 on day 1 of every 3-week cycle and docetaxel 40mg/m2 on day 1 of every 3-weeks cycle. Receives: Drug: oxaliplatin; Drug: S1; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: through study completion, an average of 2 year
Secondary outcomes (1)
progression-free survival
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2022 (estimated)
- Study completionDec 2023 (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 Gastric CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tianshu Liu, Shanghai Zhongshan Hospital
- Investigators
- Tianshu Liu, Physician, Principal investigator, Zhongshan Hopital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001726
- Sponsor's protocol ID
- NEO-REGATTA
- Status last verified
- Dec 2016
- First submitted
- 21 Dec 2016
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cui Y, Yu Y, Zheng S, Ying J, Du Y, Wang Y, Wang X, Shen Z, Liu F, Lv M, Sun Y, Liu T. Does resection after neoadjuvant chemotherapy of docetaxel, oxaliplatin, and S-1 (DOS regimen) benefit for gastric cancer patients with single non-curable factor? a multicenter, prospective cohort study (Neo-REGATTA). BMC Cancer. 2023 Apr 4;23(1):308. doi: 10.1186/s12885-023-10773-x.
PubMed 37016303
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrectomy Plus Chemotherapy Versus Chemotherapy Alone for Advanced Gastric Cancer With a Single Non-curable Factor
- ClinicalTrials.gov ID
- NCT03001726
- Acronym / sponsor ID
- NEO-REGATTA
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Dec 2016 (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.
Investigators assessed the effectiveness of conversional gastrectomy compared with chemotherapy alone following docetaxel, oxalipaltin and S1 therapy for advanced gastric cancer with a single non-curable factor.
Detailed description
Palliative chemotherapy is still the standard of care for incurable advanced gastric cancer. Several retrospective, single institutional studies have shown that the addition of gastrectomy to chemotherapy might improve patient survival among patients with metastatic gastric cancer with a single non-curable factor. However, REGATTA trial, a phase 3, randomized controlled trial, concluded an opposite conclusion that gastrectomy followed by chemotherapy did not show any survival benefit compared with chemotherapy alone in advanced gastric cancer with a single non-curable factor. Interestingly, five patients initially assigned to chemotherapy alone in the study had got survival benefit form gastrectomy with curative intent because of complete disappear of all non-curable factors during chemotherapy. This finding raised the question as to conversional radical surgery following upfront chemotherapy could be a possible treatment option. We assessed the effectiveness of conversional radical surgery following docetaxel, oxalipaltin and S1 therapy for advanced gastric cancer with a single non-curable factor.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastrectomy plus chemotherapy | – | Procedure: Gastrectomy, Drug: oxaliplatin, Drug: S1, Drug: DocetaxelIn patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location. |
| chemotherapy alone | – | Drug: oxaliplatin, Drug: S1, Drug: DocetaxelPatients received chemotherapy alone.All patients received oral S1 80 mg/m2 per day (80-120 mg/day total dose depending on the patient's body surface area as follows: <1.25 m2, 80 mg; 1.25-1.5 m2, 100 mg; and >1.5 m2, 120 mg) on days 1-21 of every 3-week cycle, oxaliplatin 100 mg/m2 on day 1 of every 3-week cycle and docetaxel 40mg/m2 on day 1 of every 3-weeks cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical diagnosis of gastric cancer with a single non-curable factor
Key inclusion criteria (2 listed)
- Clinical diagnosis of gastric cancer with a single non-curable factor
- A single non-curable factor was defined as hepatic metastasis (H1; two to four lesions of maximum diameter ≤5 cm and minimum diameter ≥1 cm); peritoneal metastasis (P1) in the diaphragm or peritoneum caudal to the transverse colon without massive ascites or intestinal obstruction; positive cytology (CY1) when the cancer cells were found in the peritoneal washing; para-aortic lymph node (PAN) metastasis above the coeliac axis or below the inferior mesenteric artery (lymph node 16a1/b2 of maximum diameter ≥1 cm), or both; or ovary implant metastasis for one site or two.
Key exclusion criteria (2 listed)
- Patients who can have radical resection.
- Patietns who have more than one metastasis.
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 |
|---|---|---|
| GastrectomyIn patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location. | Procedure or surgery | Gastrectomy plus chemotherapy |
| oxaliplatinAlso: Eloxatinoxaliplatin 100 mg/m2 | Drug | Gastrectomy plus chemotherapy, chemotherapy alone |
| S1Also: tegafurS1 40mg/m2 | Drug | Gastrectomy plus chemotherapy, chemotherapy alone |
| DocetaxelAlso: Taxoteredocetaxel 40 mg/m2 | Drug | Gastrectomy plus chemotherapy, chemotherapy alone |
Primary outcome
overall survival
Time frame: through study completion, an average of 2 year
1 secondary outcome
progression-free survival
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Derived from this study: PubMed 37016303Cui Y, Yu Y, Zheng S, Ying J, Du Y, Wang Y, Wang X, Shen Z, Liu F, Lv M, Sun Y, Liu T. Does resection after neoadjuvant chemotherapy of docetaxel, oxaliplatin, and S-1 (DOS regimen) benefit for gastric cancer patients with single non-curable factor? a multicenter, prospective cohort study (Neo-REGATTA). BMC Cancer. 2023 Apr 4;23(1):308. doi: 10.1186/s12885-023-10773-x.
- Individual participant dataSharing planned: No
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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.
Tianshu Liu, Physician principal investigator
Zhongshan Hopital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 May 2022. 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 China. 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?
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: through study completion, an average of 2 year). 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 NCT03001726, 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 6 May 2022.