Chemotherapy EffectNCT03646591
Feasibility and Safety of Neoadjuvant Chemotherapy (FLOT ) for Gastric Cancer Patients in China
An observational study of Chemotherapy Effect, run by Ruijin Hospital at 1 site in China.
Trial summary
Neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies, however, there was not any large scale randomized controlled trial (RCT) to support it until German oncologist introduced a novel regimen(FLOT regimen) in 2017. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chemotherapy Effect
- What is being tested?
- Chemotherapy
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2017to 20 Aug 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort of operable gastric cancer patients.
Who may be able to join
- Sex: all
- Histology confirmed adenocarcinoma of the stomach or esophagogastric junction.
- Clinical stage: Clinical Tumor-Node-Metastasis (cTNM): stage III，IVa
- Performance status: Eastern Cooperative Oncology Group ECOG 0- 2
- Adequate renal, hepatic, hematologic, and pulmonary function.
- Written informed consent
- Known contraindications or hypersensitivity for planned chemotherapy
Who cannot join
- Uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities
- Distant metastases
- Prior chemo or radiotherapy
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanhgai, 200025
About this study
Official title: Pilot Study on Feasibility and Safety of FLOT Regimen as Neoadjuvant Chemotherapy in Chinese Gastric Cancer Patients
Neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies, however, there was not any large scale randomized controlled trial (RCT) to support it until German oncologist introduced a novel regimen(FLOT regimen) in 2017. Investigator assessed the FLOT regimen for safety and feasibility in Chinese gastric cancer patients.
Read the detailed description
Neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies, however, there was not any large scale RCT to support it until German oncologist introduced a novel regimen(FLOT regimen) in 2017. FLOT regimen was prescribed for German patients and various questions are raised by experts from Eastern countries. As the FLOT regimen was officially included in NCCN 2018 guidelines, the investigator used standard protocol of FLOT regimen on Chinese gastric cancer patients. Safety and feasibility were assessed carefully to provide basic data for further large scale studies in China.
- Conditions
- Chemotherapy Effect
- Being tested
- Chemotherapy
- Keywords
- gastric cancer, neoadjuvant chemotherapy, FLOT regimen
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Also called FLOT
Patients will receive four cycles of the standard dose of FLOT chemotherapy prior to curative gastrectomy. And four cycles of the FLOT chemotherapy is recommended after surgery. Preventive antiemetic and dexamethasone are allowed before chemotherapy, growth factor, or other supportive medicines are allowed for treatment only. Surgical intervention is allowed for acute bleeding or other surgical emergencies.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemotherapy | FLOT Chemotherapy regimen
A cycle consist of Day 1: 5-fluorouracil (5-FU) 2600mg/M2 intravenous Via peripherally inserted central catheter (PICC) for 24 hour Day 1: Leucovorin 200mg/M2 intravenous Day 1: Oxaliplatin 85mg/ M2 intravenous Day 1: Docetaxel 50mg/M2 intravenous Repeated every 15th day Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate of preoperative FLOT regimen
How many patients completed the plan preoperative chemotherapy regimen
Measured: upto 3 months
Secondary outcomes (4)
Adverse events
Chemotherapy related adverse events according to the CTCAE version 3.0
Measured: Upto three months
Pathological response rate
According to tumor regression grading(TRG)
Measured: Upto three months
Postoperative morbidity
Postoperative complications
Measured: Upto one month after hospital discharge
Postoperative mortality
Death due to surgical complication
Measured: Upto one month after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start15 Nov 2017
- Primary completion20 Aug 2018
- Study completion20 Aug 2018
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 Chemotherapy EffectStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BIRENDRA KUMAR SAH, Ruijin Hospital
- Investigators
- Birendra K Sah, PH D, Principal investigator, Ruijin HospitalChen Li, PH D, Study director, Ruijin HospitalZhenggang Zhu, PH D, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646591
- Sponsor's protocol ID
- Dragon III- Pilot study
- Status last verified
- Nov 2020
- First submitted
- 23 Aug 2018
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sah BK, Xu W, Zhang B, Zhang H, Yuan F, Li J, Liu W, Yan C, Li C, Yan M, Zhu Z. Feasibility and Safety of Perioperative Chemotherapy With Fluorouracil Plus Leucovorin, Oxaliplatin, and Docetaxel for Locally Advanced Gastric Cancer Patients in China. Front Oncol. 2021 Jan 18;10:567529. doi: 10.3389/fonc.2020.567529. eCollection 2020.
PubMed 33537232
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Feasibility and Safety of FLOT Regimen as Neoadjuvant Chemotherapy in Chinese Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT03646591
- Acronym / sponsor ID
- Dragon III- Pilot study
- Conditions
- Chemotherapy Effect
- Keywords
- gastric cancer, neoadjuvant chemotherapy, FLOT regimen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 24 Aug 2018 (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.
Neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies, however, there was not any large scale randomized controlled trial (RCT) to support it until German oncologist introduced a novel regimen(FLOT regimen) in 2017. Investigator assessed the FLOT regimen for safety and feasibility in Chinese gastric cancer patients.
Detailed description
Neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies, however, there was not any large scale RCT to support it until German oncologist introduced a novel regimen(FLOT regimen) in 2017. FLOT regimen was prescribed for German patients and various questions are raised by experts from Eastern countries. As the FLOT regimen was officially included in NCCN 2018 guidelines, the investigator used standard protocol of FLOT regimen on Chinese gastric cancer patients. Safety and feasibility were assessed carefully to provide basic data for further large scale studies in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemotherapy | – | Drug: ChemotherapyFLOT Chemotherapy regimen A cycle consist of Day 1: 5-fluorouracil (5-FU) 2600mg/M2 intravenous Via peripherally inserted central catheter (PICC) for 24 hour Day 1: Leucovorin 200mg/M2 intravenous Day 1: Oxaliplatin 85mg/ M2 intravenous Day 1: Docetaxel 50mg/M2 intravenous Repeated every 15th day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of operable gastric cancer patients.
Key inclusion criteria (7 listed)
- Sex: all
- Histology confirmed adenocarcinoma of the stomach or esophagogastric junction.
- Clinical stage: Clinical Tumor-Node-Metastasis (cTNM): stage III，IVa
- Performance status: Eastern Cooperative Oncology Group ECOG 0- 2
- Adequate renal, hepatic, hematologic, and pulmonary function.
Key exclusion criteria (3 listed)
- Uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities
- Distant metastases
- Prior chemo or radiotherapy
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 |
|---|---|---|
| ChemotherapyAlso: FLOTPatients will receive four cycles of the standard dose of FLOT chemotherapy prior to curative gastrectomy. And four cycles of the FLOT chemotherapy is recommended after surgery. Preventive antiemetic and dexamethasone are allowed before chemotherapy, growth factor, or other supportive medicines are allowed for treatment only. Surgical intervention is allowed for acute bleeding or other surgical emergencies. | Drug | Neoadjuvant chemotherapy |
Primary outcome
Completion rate of preoperative FLOT regimen
Time frame: upto 3 months
How many patients completed the plan preoperative chemotherapy regimen
4 secondary outcomes
Adverse events
Time frame: Upto three months
Pathological response rate
Time frame: Upto three months
Postoperative morbidity
Time frame: Upto one month after hospital discharge
Postoperative mortality
Time frame: Upto one month after hospital discharge
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 13 Nov 2020.
- Derived from this study: PubMed 33537232Sah BK, Xu W, Zhang B, Zhang H, Yuan F, Li J, Liu W, Yan C, Li C, Yan M, Zhu Z. Feasibility and Safety of Perioperative Chemotherapy With Fluorouracil Plus Leucovorin, Oxaliplatin, and Docetaxel for Locally Advanced Gastric Cancer Patients in China. Front Oncol. 2021 Jan 18;10:567529. doi: 10.3389/fonc.2020.567529. eCollection 2020.
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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.
Birendra K Sah, PH D principal investigator
Ruijin Hospital
Chen Li, PH D study director
Ruijin Hospital
Zhenggang Zhu, PH D study chair
Ruijin Hospital
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 Chemotherapy Effect, run by Ruijin 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 7 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 13 Nov 2020. 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?
Completion rate of preoperative FLOT regimen (time frame: upto 3 months). 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 NCT03646591, 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 13 Nov 2020.