Gastric CancerNCT04198051
The Clinical Study of Adjuvant Chemotherapy on Intestinal and Urethral Flora in Patients With Gastric and Colon Cancer
A study testing adjuvant chemotherapy in people with Gastric Cancer and Colon Cancer, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial summary
The human intestine is colonized with a complex microbial community and forms a super organism with the human body. Intestinal microorganisms include more than 1,000 kinds of bacterias, and their flora is very complex and functions are very diverse. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer, Colon Cancer
- What is being tested?
- adjuvant chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2019to 1 May 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old, male or female
- Surgery specimens were clearly diagnosed as gastric cancer and colon cancer by histopathology
- The operation method is not limited (both laparoscopic surgery and open surgery)
- After the perioperative period, stop using antibiotics for not less than 2 weeks
- It is planned to receive a chemotherapy regimen with a combination of platinum and fluorouracil for a period of 21 days (gastric cancer is the SOX or XELOX regimen, and colon cancer is the XELOX or FOLFOX regimen)
- Blood routine, biochemical and other related laboratory tests showed no obvious abnormalities
- There are no contraindications for related adjuvant chemotherapy indications.
Who cannot join
- Neoadjuvant treatment before gastric and bowel cancer surgery
- Previous history: He has suffered from intestinal microecology-related diseases such as cirrhosis, ulcerative colitis, Crohn's disease, irritable bowel syndrome, and urinary system diseases
- Before the perioperative period, because of anastomotic fistula and gastrointestinal perforation, reoperation
- The following drugs were used within 2 weeks before enrollment:
- Various antibiotics, including antifungals (oral and intravenous)
- Probiotic preparations, various prebiotic preparations, etc c Glucocorticoids; d Take drugs known to have a significant effect on the intestinal and urethral flora within half a year (such as proton pump inhibitors, purgatives, bismuth, adsorbents, non-steroidal anti-inflammatory drugs, etc.)
- Other situations that the researcher considers unsuitable to participate in the experiment;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116000
Xiaonan Cui, MD,PhD, +8618098876725, cxn23@sina.com
About this study
The human intestine is colonized with a complex microbial community and forms a super organism with the human body. Intestinal microorganisms include more than 1,000 kinds of bacterias, and their flora is very complex and functions are very diverse. The intestinal flora affects the body's nutrition, immunity and metabolism through interaction with the human body and the external environment, and is closely related to multiple systems. When the flora structure and function are changed, it will lead to the occurrence of various diseases or increase the risk of disease. In recent years, the role of intestinal microbes in tumorigenesis and development, as well as the role of diagnosis and treatment have been paid more and more attention. Abnormal intestinal flora can not only promote tumorigenesis, but also affect radiochemotherapy and immunotherapy effects. It is worth noting that the huge impact of the intestinal flora on immunotherapy suggests that immune checkpoint inhibitors can maximize the efficacy by protecting the balance and diversity of the intestinal microecology. Therefore, in this study, quantitative analysis of the diversity and abundance of intestinal, urinary tract flora, and urine components before and after adjuvant chemotherapy in patients with gastric and bowel cancer was performed. The link between treatment efficacy and prognosis.
- Conditions
- Gastric Cancer, Colon Cancer
- Being tested
- adjuvant chemotherapy
- Medical subject headings
- Stomach Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjuvant chemotherapyDrug
Form、dosage and frequency： Gastric cancer was given the SOX regimen (oxaliplatin + tegafur regimen,oxaliplatin 130mg/m2 intravenous infusion, the 1st day; tegafur 80mg/ m2/d orally Bid, the 1st to 14th day, every 21 days is one cycle) or XELOX regimen (oxaliplatin + capecitabine regimen，oxaliplatin 130mg/m2 intravenous infusion, the 1st day; capecitabine 1000mg/m2/d orally Bid, the 1st to 14th day, every 21 days is one cycle).
Colon cancer was given the XELOX regimen (the dosage、frequency and administration are the same as the gastric cancer) or FOLFOX regimen (oxaliplatin + calcium folinate + fluorouracil regimen，oxaliplatin 85mg/m2 intravenous infusion, the 1st day; calcium folinate 400 mg/m2 intravenous infusion, the 1st day; fluorouracil 400 mg/m2 intravenous infusion, the 1st day, then 1200 mg/m2/d × 2d continuous intravenous infusion，every 14 days is one cycle).
Duration：through chemotherapy completion，about six months.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Not described Receives: Drug: adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of diversity of intestinal flora in faeces during chemotherapy
Measured: The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.
The change of diversity of urethral flora in urine during chemotherapy
Measured: The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.
The change of abundance of intestinal flora in faeces during chemotherapy
Measured: The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.
The change of abundance of urethral flora in urine during chemotherapy
Measured: The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.
The change of concentration of purine metabolites in urine during chemotherapy
Measured: The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.
The change of concentration of P-hydroxyphenylalanine metabolites in urine during chemotherapy
Measured: The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.
Secondary outcomes (4)
The change of the number of Gastrin in blood during chemotherapy
Measured: the 1st day before the start of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, 6 months.
The change of the number of CD4+T cell and CD8+T cell in blood during chemotherapy chemotherapy
Measured: the 1st day before the start of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, 6 months.
The change of the number of Interleukin(IL)-2,Interleukin(IL)-4,Interleukin(IL)-6, in blood during chemotherapy
Measured: the 1st day before the start of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, 6 months.
The change of the number of tumor necrosis factor(TNF)-α in blood during chemotherapy
Measured: the 1st day before the start of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start20 Dec 2019 (estimated)
- Primary completion20 Dec 2020 (estimated)
- Study completion1 May 2021 (estimated)
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaonan Cui, MD,PhD, Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198051
- Sponsor's protocol ID
- PJ-KY-2019-101
- Status last verified
- Sep 2019
- First submitted
- 3 Dec 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of Adjuvant Chemotherapy on Intestinal and Urethral Flora in Patients With Gastric and Colon Cancer
- ClinicalTrials.gov ID
- NCT04198051
- Acronym / sponsor ID
- PJ-KY-2019-101
- Conditions
- Gastric Cancer, Colon Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 20 Dec 2019 (estimated)
- Primary completion
- 20 Dec 2020 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 13 Dec 2019 (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.
The human intestine is colonized with a complex microbial community and forms a super organism with the human body. Intestinal microorganisms include more than 1,000 kinds of bacterias, and their flora is very complex and functions are very diverse. The intestinal flora affects the body's nutrition, immunity and metabolism through interaction with the human body and the external environment, and is closely related to multiple systems. When the flora structure and function are changed, it will lead to the occurrence of various diseases or increase the risk of disease. In recent years, the role of intestinal microbes in tumorigenesis and development, as well as the role of diagnosis and treatment have been paid more and more attention. Abnormal intestinal flora can not only promote tumorigenesis, but also affect radiochemotherapy and immunotherapy effects. It is worth noting that the huge impact of the intestinal flora on immunotherapy suggests that immune checkpoint inhibitors can maximize the efficacy by protecting the balance and diversity of the intestinal microecology. Therefore, in this study, quantitative analysis of the diversity and abundance of intestinal, urinary tract flora, and urine components before and after adjuvant chemotherapy in patients with gastric and bowel cancer was performed. The link between treatment efficacy and prognosis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: adjuvant chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-70 years old, male or female
- Surgery specimens were clearly diagnosed as gastric cancer and colon cancer by histopathology
- The operation method is not limited (both laparoscopic surgery and open surgery)
- After the perioperative period, stop using antibiotics for not less than 2 weeks
- It is planned to receive a chemotherapy regimen with a combination of platinum and fluorouracil for a period of 21 days (gastric cancer is the SOX or XELOX regimen, and colon cancer is the XELOX or FOLFOX regimen)
Key exclusion criteria (7 listed)
- Neoadjuvant treatment before gastric and bowel cancer surgery
- Previous history: He has suffered from intestinal microecology-related diseases such as cirrhosis, ulcerative colitis, Crohn's disease, irritable bowel syndrome, and urinary system diseases
- Before the perioperative period, because of anastomotic fistula and gastrointestinal perforation, reoperation
- The following drugs were used within 2 weeks before enrollment:
- Other situations that the researcher considers unsuitable to participate in the experiment;
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 |
|---|---|---|
| adjuvant chemotherapyForm、dosage and frequency： Gastric cancer was given the SOX regimen (oxaliplatin + tegafur regimen,oxaliplatin 130mg/m2 intravenous infusion, the 1st day; tegafur 80mg/ m2/d orally Bid, the 1st to 14th day, every 21 days is one cycle) or XELOX regimen (oxaliplatin + capecitabine regimen，oxaliplatin 130mg/m2 intravenous infusion, the 1st day; capecitabine 1000mg/m2/d orally Bid, the 1st to 14th day, every 21 days is one cycle). Colon cancer was given the XELOX regimen (the dosage、frequency and administration are the same as the gastric cancer) or FOLFOX regimen (oxaliplatin + calcium folinate + fluorouracil regimen，oxaliplatin 85mg/m2 intravenous infusion, the 1st day; calcium folinate 400 mg/m2 intravenous infusion, the 1st day; fluorouracil 400 mg/m2 intravenous infusion, the 1st day, then 1200 mg/m2/d × 2d continuous intravenous infusion，every 14 days is one cycle). Duration：through chemotherapy completion，about six months. | Drug | treatment group |
Primary outcome
The change of diversity of intestinal flora in faeces during chemotherapy
Time frame: The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.
The change of diversity of urethral flora in urine during chemotherapy
Time frame: The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.
The change of abundance of intestinal flora in faeces during chemotherapy
Time frame: The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.
The change of abundance of urethral flora in urine during chemotherapy
Time frame: The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.
The change of concentration of purine metabolites in urine during chemotherapy
Time frame: The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.
The change of concentration of P-hydroxyphenylalanine metabolites in urine during chemotherapy
Time frame: The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.
4 secondary outcomes
The change of the number of Gastrin in blood during chemotherapy
Time frame: the 1st day before the start of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, 6 months.
The change of the number of CD4+T cell and CD8+T cell in blood during chemotherapy chemotherapy
Time frame: the 1st day before the start of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, 6 months.
The change of the number of Interleukin(IL)-2,Interleukin(IL)-4,Interleukin(IL)-6, in blood during chemotherapy
Time frame: the 1st day before the start of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, 6 months.
The change of the number of tumor necrosis factor(TNF)-α in blood during chemotherapy
Time frame: the 1st day before the start of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
Xiaonan Cui, MD,PhD principal investigator
The First Affiliated Hospital of Dalian Medical 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 adjuvant chemotherapy in people with Gastric Cancer and Colon Cancer, run by The First Affiliated Hospital of Dalian Medical University 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 7 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: status not confirmed, as of the sponsor's last update on 13 Dec 2019. 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?
Contact Xiaonan Cui, MD,PhD (+8618098876725, cxn23@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of diversity of intestinal flora in faeces during chemotherapy (time frame: The 1st day before the start of each cycle of chemotherapy, and the 1st day after the completion of each cycle of chemotherapy(each cycle is 21 days,except for the FOLFOX regimen of colon cancer is 14 days),through chemotherapy completion, six months.). The study lists 6 primary outcomes in all. 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 13 Dec 2019.