Status:
NOT_YET_RECRUITING
Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients
Lead Sponsor:
BIRENDRA KUMAR SAH
Conditions:
Gastric Cancer
Chemotherapy Effect
Eligibility:
All Genders
76+ years
Phase:
PHASE2
PHASE3
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 st...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT04677673
Start Date
January 1 2021
End Date
January 1 2027
Last Update
December 21 2020
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