Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients

Surgery Clinical Trial

— RJGC-Senile  

Official title:

Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04677673
• Other study ID #: Dragon Senile
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: January 2021
• Est. completion date: January 2027

Study information

• Verified date: December 2020
• Source: Ruijin Hospital
• Contact: Birendra K Sah
• Phone: 0086-21-64370045
• Email: rjsurgeon[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 232
• Est. completion date: January 2027
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 76 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy Effect
• Elderly Patients
• Gastric Cancer
• Stomach Neoplasms
• Surgery

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BIRENDRA KUMAR SAH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Time from randomization to death from any cause	Five years
Secondary	Completion rate of planned NAC	Completion rate of planned chemotherapy before surgery.	Three months
Secondary	Percentage of Grade 3/4 hematological adverse events	Percentage of Grade 3/4 hematological adverse events during neoadjuvant chemotherapy	Three months
Secondary	Pathological response	Total percentage of patients with pathological complete tumor regression (TRG1a) and sub-total tumor regression (TRG1b) in the primary tumor	Four months
Secondary	Disease-free survival (DFS)	Time from randomization to relapse of the disease	Two years