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NCT Number: NCT04677673

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

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.

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Key information

Conditions

Gastric Cancer Chemotherapy Effect Digestive System Diseases Digestive System Neoplasms Elderly Patients Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms Surgery

Age range

76 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

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

Other names: Modified SOX

Curative gastrectomy

Procedure

Radical gastrectomy with D2 lymph node dissection

Primary outcomes

  1. Overall Survival

    Time frame: Five years

    Time from randomization to death from any cause

Secondary outcomes

  1. Completion rate of planned NAC

    Time frame: Three months

    Completion rate of planned chemotherapy before surgery.

  2. Percentage of Grade 3/4 hematological adverse events

    Time frame: Three months

    Percentage of Grade 3/4 hematological adverse events during neoadjuvant chemotherapy

  3. Pathological response

    Time frame: Four months

    Total percentage of patients with pathological complete tumor regression (TRG1a) and sub-total tumor regression (TRG1b) in the primary tumor

  4. Disease-free survival (DFS)

    Time frame: Two years

    Time from randomization to relapse of the disease

Study contacts

Contact information is provided by the study sponsor or research team.

Birendra K Sah

CONTACT

[email protected]

0086-21-64370045 ext. 6701302

Zhenggang Zhu

CONTACT

Sponsors and collaborators

Lead sponsor

BIRENDRA KUMAR SAH

Other

Registry information

Acronym: RJGC-Senile

Important dates

Study start
2021
Primary completion
2022
Study completion
2027
First posted
Dec 21, 2020
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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