Gastric CancerNCT03238404
Neoadjuvant Chemotherapy for Patients With Advanced Gastric Cancer in ERAS Programs for Radical Gastrectomy
A study testing NAC group and Surgery alone group in people with Gastric Cancer, run by JIANG Zhi-Wei at 1 site in China.
Trial summary
Patients with advanced gastric cancer received neoadjuvant chemotherapy undergo enhanced recovery after surgery (ERAS) 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?
- NAC group and Surgery alone group
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2015to 20 Dec 2016
- 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 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: The Application of Neoadjuvant Chemotherapy for Patients With Advanced Gastric Cancer in Enhanced Recovery After Surgery Programs for Radical Gastrectomy
Patients with advanced gastric cancer received neoadjuvant chemotherapy undergo enhanced recovery after surgery (ERAS) programs.
Read the detailed description
In recent years, enhanced recovery after surgery (ERAS) programs were applied in gastrectomy in areas with a high prevalence of gastric cancer, such as China and Japan, confirming that ERAS programs accelerate the postoperative rehabilitation of gastric cancer patients without increasing the occurrence rate of postoperative complications. However, in most studies on ERAS for gastric cancer, patients who received neoadjuvant chemotherapy were excluded. Investigators designed this study aimed to evaluate whether patients who receive neoadjuvant chemotherapy can enrolled into enhanced recovery after surgery programs for locally advanced gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- NAC group, Surgery alone group
- Keywords
- gastric cancer, neoadjuvant chemotherapy, enhanced recovery after surgery, gastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAC groupProcedure or surgery
NAC is the name of a procedure. NAC doesn't mean different interventions are used. Patients in this group need receive this NAC procedure instead of one drug before the gastrectomy and ERAS. The program consists of an intravenous injection of 130 mg/m2 oxaliplatin on day 1, followed by oral administration of 50 mg tegafur gimerac (the name of an anticarcinogen) twice daily on days 1-14, every 3 weeks.
Surgery alone groupProcedure or surgery
Patients will not receive neoadjuvant chemotherapy and they will undergo the gastrectomy and ERAS alone.
| Study group | Role | What they receive |
|---|---|---|
| NAC group | Experimental | Patients will receive neoadjuvant chemotherapy (NAC) before the gastrectomy and ERAS. Receives: Procedure: NAC group |
| Surgery alone group | Active comparator | Patients will not receive NAC before the gastrectomy and ERAS. Receives: Procedure: Surgery alone 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 (6)
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 weeks
Total protein
Nutritional status
Measured: 1 week
Albumin
Nutritional status
Measured: 1 week
Prealbumin
Nutritional status
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Aug 2015
- Primary completion10 Aug 2016
- Study completion20 Dec 2016
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 single-center, parallel, open-label randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 88 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
- Zhi-Wei JIANG, Ph.D., Principal investigator, Jinling Hospital, Medical School of Nanjing UniversityJian ZHAO, Ph.D., Study director, Jinling Hospital, Medical School of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238404
- Sponsor's protocol ID
- BE2015687NAC
- Status last verified
- Aug 2017
- First submitted
- 27 Jul 2017
- Last updated
- 3 Aug 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 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Neoadjuvant Chemotherapy for Patients With Advanced Gastric Cancer in Enhanced Recovery After Surgery Programs for Radical Gastrectomy
- ClinicalTrials.gov ID
- NCT03238404
- Acronym / sponsor ID
- BE2015687NAC
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, neoadjuvant chemotherapy, enhanced recovery after surgery, gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- JIANG Zhi-WeiUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 10 Aug 2016 (actual)
- Study completion
- 20 Dec 2016 (actual)
- First posted
- 3 Aug 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 with advanced gastric cancer received neoadjuvant chemotherapy undergo enhanced recovery after surgery (ERAS) programs.
Detailed description
In recent years, enhanced recovery after surgery (ERAS) programs were applied in gastrectomy in areas with a high prevalence of gastric cancer, such as China and Japan, confirming that ERAS programs accelerate the postoperative rehabilitation of gastric cancer patients without increasing the occurrence rate of postoperative complications. However, in most studies on ERAS for gastric cancer, patients who received neoadjuvant chemotherapy were excluded. Investigators designed this study aimed to evaluate whether patients who receive neoadjuvant chemotherapy can enrolled into enhanced recovery after surgery 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 single-center, parallel, open-label randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| NAC group | Experimental | Procedure: NAC groupPatients will receive neoadjuvant chemotherapy (NAC) before the gastrectomy and ERAS. |
| Surgery alone group | Active comparator | Procedure: Surgery alone groupPatients will not receive NAC before the gastrectomy and ERAS. |
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 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 |
|---|---|---|
| NAC groupNAC is the name of a procedure. NAC doesn't mean different interventions are used. Patients in this group need receive this NAC procedure instead of one drug before the gastrectomy and ERAS. The program consists of an intravenous injection of 130 mg/m2 oxaliplatin on day 1, followed by oral administration of 50 mg tegafur gimerac (the name of an anticarcinogen) twice daily on days 1-14, every 3 weeks. | Procedure or surgery | NAC group |
| Surgery alone groupPatients will not receive neoadjuvant chemotherapy and they will undergo the gastrectomy and ERAS alone. | Procedure or surgery | Surgery alone group |
Primary outcome
Postoperative length of stay
Time frame: 1 month
Postoperative length of stay
6 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 weeks
Total protein
Time frame: 1 week
Albumin
Time frame: 1 week
Prealbumin
Time frame: 1 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 3 Aug 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.
Zhi-Wei JIANG, Ph.D. principal investigator
Jinling Hospital, Medical School of Nanjing University
Jian ZHAO, Ph.D. 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 NAC group and Surgery alone 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 3 Aug 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 3 Aug 2017.