Gastric CancerPhase 2/3RJGC-SenileNCT04677673
Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients
A Phase 2/3 study testing Chemotherapy and Curative gastrectomy in people with Gastric Cancer and Chemotherapy Effect, run by BIRENDRA KUMAR SAH.
Trial summary
The main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified SOX) for elderly patients with locally advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 76 years and older
- Conditions the study is for
- Gastric Cancer, Chemotherapy Effect, Elderly Patients
- What is being tested?
- Chemotherapy and Curative gastrectomy
- 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
- 232 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jan 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 76 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.
- Clinical stage: cTNM: stage III
- Performance status: Eastern Cooperative Oncology Group ECOG ≤ 2 (normal to symptomatic but in bed less than half the day)
- Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.
- Written informed consent
- Known contraindications or hypersensitivity for planned chemotherapy
Who cannot join
- Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia
- Distant metastases (including retroperitoneal lymph node)
- Locally advanced inoperable disease (Clinical assessment)
- Relapse of gastric cancer
- Malignant secondary disease
- Prior chemo or radiotherapy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Zhenggang Zhu contact
About this study
The main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified SOX) for elderly patients with locally advanced gastric cancer.
Read the detailed description
DRAGON SENILE research, Neoadjuvant Chemotherapy plus Surgery versus surgery first for elderly Gastric Cancer patients, is an investigator-initiated; phase II/III, open-label, randomized controlled study. The main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified SOX) for elderly patients with locally advanced gastric cancer.
- Conditions
- Gastric Cancer, Chemotherapy Effect, Elderly Patients, Surgery
- Being tested
- Chemotherapy, Curative 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.
ChemotherapyDrug
Also called Modified SOX
Modified SOX Chemotherapy regimen A cycle consists of Day 1: Oxaliplatin 100mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 60mg/M2 oral (twice daily) Repeated every 22nd day
Curative gastrectomyProcedure or surgery
Radical gastrectomy with D2 lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| NAC PLUS SURGERY | Experimental | Patients receive three cycles of the modified dose of TGO plus oxaliplatin before curative gastrectomy. Receives: Drug: Chemotherapy |
| SURGERY FIRST | Active comparator | Patients undergo curative gastrectomy without any prior chemotherapy. Receives: Procedure: Curative gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Time from randomization to death from any cause
Measured: Five years
Secondary outcomes (4)
Completion rate of planned NAC
Completion rate of planned chemotherapy before surgery.
Measured: Three months
Percentage of Grade 3/4 hematological adverse events
Percentage of Grade 3/4 hematological adverse events during neoadjuvant chemotherapy
Measured: Three months
Pathological response
Total percentage of patients with pathological complete tumor regression (TRG1a) and sub-total tumor regression (TRG1b) in the primary tumor
Measured: Four months
Disease-free survival (DFS)
Time from randomization to relapse of the disease
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2027 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BIRENDRA KUMAR SAH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, BIRENDRA KUMAR SAH, Ruijin Hospital
- Investigators
- Zhenggang Zhu, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677673
- Sponsor's protocol ID
- Dragon Senile
- Acronym
- RJGC-Senile
- Status last verified
- Dec 2020
- First submitted
- 17 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT04677673
- Acronym / sponsor ID
- RJGC-Senile / Dragon Senile
- Conditions
- Gastric Cancer, Chemotherapy Effect, Elderly Patients, Surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- BIRENDRA KUMAR SAHUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Dec 2020 (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 main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified SOX) for elderly patients with locally advanced gastric cancer.
Detailed description
DRAGON SENILE research, Neoadjuvant Chemotherapy plus Surgery versus surgery first for elderly Gastric Cancer patients, is an investigator-initiated; phase II/III, open-label, randomized controlled study. The main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified SOX) for elderly patients with locally advanced gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAC PLUS SURGERY | Experimental | Drug: ChemotherapyPatients receive three cycles of the modified dose of TGO plus oxaliplatin before curative gastrectomy. |
| SURGERY FIRST | Active comparator | Procedure: Curative gastrectomyPatients undergo curative gastrectomy without any prior chemotherapy. |
Who may qualify
- Ages
- 76 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.
- Clinical stage: cTNM: stage III
- Performance status: Eastern Cooperative Oncology Group ECOG ≤ 2 (normal to symptomatic but in bed less than half the day)
- Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.
- Written informed consent
Key exclusion criteria (6 listed)
- Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia
- Distant metastases (including retroperitoneal lymph node)
- Locally advanced inoperable disease (Clinical assessment)
- Relapse of gastric cancer
- Malignant secondary disease
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: Modified SOXModified SOX Chemotherapy regimen A cycle consists of Day 1: Oxaliplatin 100mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 60mg/M2 oral (twice daily) Repeated every 22nd day | Drug | NAC PLUS SURGERY |
| Curative gastrectomyRadical gastrectomy with D2 lymph node dissection | Procedure or surgery | SURGERY FIRST |
Primary outcome
Overall Survival
Time frame: Five years
Time from randomization to death from any cause
4 secondary outcomes
Completion rate of planned NAC
Time frame: Three months
Percentage of Grade 3/4 hematological adverse events
Time frame: Three months
Pathological response
Time frame: Four months
Disease-free survival (DFS)
Time frame: Two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Gastric Cancer
Recruiting
TEAS Timing for Gastrectomy Recovery (TEAS-TIME Trial)
Gastric Cancer (GC), Stomach Neoplasms
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08098488 in People With Advanced Solid Tumors.
Pancreatic Ductal Adenocarcinoma, Esophageal Cancer
RecruitingPhase 1
Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors
Breast Cancer, Non-small Cell Lung Cancer (NSCLC)
RecruitingPhase 1
A Phase 1 Study of IM-1617 in Participants With Advanced Cancer
Colorectal Cancer, Non-Small Cell Lung Cancer
RecruitingPhase 1
Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor
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.
Zhenggang Zhu contact
Zhenggang Zhu study chair
Ruijin Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Chemotherapy and Curative gastrectomy in people with Gastric Cancer and Chemotherapy Effect, run by BIRENDRA KUMAR SAH.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Birendra K Sah (0086-21-64370045 ext. 6701302, rjsurgeon@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Five years). 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 21 Dec 2020.