Chemotherapy Effect, Elderly Patients, Gastric Cancer, Surgery
Conditions
Brief 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.
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
DRUGChemotherapy
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
PROCEDURECurative gastrectomy
Radical gastrectomy with D2 lymph node dissection
Sponsors
BIRENDRA KUMAR SAH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
76 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Five years | Time from randomization to death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion rate of planned NAC | Three months | Completion rate of planned chemotherapy before surgery. |
| Percentage of Grade 3/4 hematological adverse events | Three months | Percentage of Grade 3/4 hematological adverse events during neoadjuvant chemotherapy |
| Pathological response | Four months | Total percentage of patients with pathological complete tumor regression (TRG1a) and sub-total tumor regression (TRG1b) in the primary tumor |
| Disease-free survival (DFS) | Two years | Time from randomization to relapse of the disease |
Contacts
Primary ContactBirendra K Sah
Backup ContactZhenggang Zhu
Outcome results
None listed