Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chemotherapy, Curative gastrectomy.
- Who it may be relevant to
- Registry conditions: Gastric Cancer, Chemotherapy Effect, Elderly Patients, Surgery. Basic parameters: from 76 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Chemotherapy
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 - Procedure Curative gastrectomy
Radical gastrectomy with D2 lymph node dissection
Primary outcome measures
- Overall Survival [Time frame: Five years]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- Inclusion in another clinical trial
- Known contraindications or hypersensitivity for planned chemotherapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04677673 · Dragon Senile