Gastric CancerERASNACNCT03272984
ERAS for Patients Received Neoadjuvant Chemotherapy
A study testing ERAS group and SC group in people with Gastric Cancer, run by JIANG Zhi-Wei at 1 site in China.
Trial summary
Patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the enhanced recovery after surgery (ERAS) programs or the standard cares (SC) programs. 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?
- ERAS group and SC group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2015to 6 Jul 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients received neoadjuvant chemotherapy with locally advanced gastric cancer.
- Age older than 18 and younger than 75 years.
- American Society of Anesthesiologists (ASA) class: I-III.
- Participants can describe the symptom objectively and cooperate actively.
- Written informed consent.
Who cannot join
- Patients allergic to oxaliplatin, tegafur gimerac etc.
- Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function > II (NYHA)
- Patients with complications (bleeding, perforation and obstruction) caused by gastric cancer.
- Patients with severe liver and renal dysfunction (Child - Pugh ≥ 10; Cr < 25 ml/min).
- Patients who require simultaneous surgery for other diseases.
- Patients who received upper abdominal surgery previously.
- Pregnant or breast-feeding women.
Trial locations and contacts
1 site in 1 country.
China1 site
Jinling Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210002
About this study
Official title: Enhanced Recovery After Surgery Programs for Patients Received Neoadjuvant Chemotherapy With Locally Advanced Gastric Cancer: a Randomized Controlled Clinical Trial
Patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the enhanced recovery after surgery (ERAS) programs or the standard cares (SC) programs.
Read the detailed description
Before, most trials about the ERAS for radical gastrectomy demonstrated ERAS programs accelerate the postoperative rehabilitation of gastric cancer patients without increasing postoperative complications. However, in most trials, patients who received neoadjuvant chemotherapy were excluded. The investigators designed this trial for patients received neoadjuvant chemotherapy. In this trial, patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the ERAS programs or the SC programs. Finally, the investigators evaluated whether patients who receive neoadjuvant chemotherapy can be enrolled into the ERAS programs for locally advanced gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- ERAS group, SC group
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS groupProcedure or surgery
ERAS is the name of a procedure. Patients in this group need receive the ERAS procedure instead of one drug.
SC groupProcedure or surgery
Patients were managed in accordance with SC programs during the perioperative period. SC programs were used daily in our center and were still routinely used in most of the other hospitals in China.
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Experimental | Patients will undergo the ERAS programs. Receives: Procedure: ERAS group |
| SC group | Other | Patients will undergo the SC group. Receives: Procedure: SC group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative length of stay
Postoperative length of stay
Measured: 1 month
Secondary outcomes (3)
Postoperative complications
Postoperative complications
Measured: 2 months
The time to first flatus
Bowel recovery
Measured: 1 week
Time to semi-liquid diet
Bowel recovery
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start1 Apr 2015
- Primary completion5 Jun 2017
- Study completion6 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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
- Model description
- This study is a parallel, open-label randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- JIANG Zhi-Wei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JIANG Zhi-Wei, Jinling Hospital, China
- Investigators
- Zhiwei JIANG, MD, Principal investigator, Jinling Hospital, Medical School of Nanjing UniversityJian ZHAO, MD, Study director, Jinling Hospital, Medical School of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272984
- Sponsor's protocol ID
- 8150041701
- Acronym
- ERASNAC
- Status last verified
- Sep 2017
- First submitted
- 4 Sep 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results and IPD will be considered to share in published articles.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery Programs for Patients Received Neoadjuvant Chemotherapy With Locally Advanced Gastric Cancer: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03272984
- Acronym / sponsor ID
- ERASNAC / 8150041701
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- JIANG Zhi-WeiUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 5 Jun 2017 (actual)
- Study completion
- 6 Jul 2017 (actual)
- First posted
- 6 Sep 2017 (actual)
- 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.
Patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the enhanced recovery after surgery (ERAS) programs or the standard cares (SC) programs.
Detailed description
Before, most trials about the ERAS for radical gastrectomy demonstrated ERAS programs accelerate the postoperative rehabilitation of gastric cancer patients without increasing postoperative complications. However, in most trials, patients who received neoadjuvant chemotherapy were excluded. The investigators designed this trial for patients received neoadjuvant chemotherapy. In this trial, patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the ERAS programs or the SC programs. Finally, the investigators evaluated whether patients who receive neoadjuvant chemotherapy can be enrolled into the ERAS programs for locally advanced gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a parallel, open-label randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| ERAS group | Experimental | Procedure: ERAS groupPatients will undergo the ERAS programs. |
| SC group | Other | Procedure: SC groupPatients will undergo the SC group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients received neoadjuvant chemotherapy with locally advanced gastric cancer.
- Age older than 18 and younger than 75 years.
- American Society of Anesthesiologists (ASA) class: I-III.
- Participants can describe the symptom objectively and cooperate actively.
- Written informed consent.
Key exclusion criteria (7 listed)
- Patients allergic to oxaliplatin, tegafur gimerac etc.
- Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function > II (NYHA)
- Patients with complications (bleeding, perforation and obstruction) caused by gastric cancer.
- Patients with severe liver and renal dysfunction (Child - Pugh ≥ 10; Cr < 25 ml/min).
- Patients who require simultaneous surgery for other diseases.
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 |
|---|---|---|
| ERAS groupERAS is the name of a procedure. Patients in this group need receive the ERAS procedure instead of one drug. | Procedure or surgery | ERAS group |
| SC groupPatients were managed in accordance with SC programs during the perioperative period. SC programs were used daily in our center and were still routinely used in most of the other hospitals in China. | Procedure or surgery | SC group |
Primary outcome
Postoperative length of stay
Time frame: 1 month
Postoperative length of stay
3 secondary outcomes
Postoperative complications
Time frame: 2 months
The time to first flatus
Time frame: 1 week
Time to semi-liquid diet
Time frame: 2 week
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 8 Sep 2017.
- Individual participant dataSharing planned: Undecided. The results and IPD will be considered to share in published articles.
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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.
Zhiwei JIANG, MD principal investigator
Jinling Hospital, Medical School of Nanjing University
Jian ZHAO, MD study director
Jinling Hospital, Medical School of Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS group and SC group in people with Gastric Cancer, run by JIANG Zhi-Wei 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 5 inclusion and 7 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 8 Sep 2017. 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?
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?
Postoperative length of stay (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2017; AzTrials last refreshed its copy on 1 Nov 2026.