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NCT04677673Not yet recruitingPhase 2/3

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

Source: ClinicalTrials.gov · Last updated 21 Dec 2020 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
232 (estimated)
First submitted
17 Dec 2020
Start date
Jan 2021
Primary completion date
Jan 2022
Lead sponsor
BIRENDRA KUMAR SAH
NCT number
NCT04677673

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 232
  • From Jan 2021 to the primary completion date, Jan 2022
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior chemo or radiotherapy

Other illness

  • 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
  • Locally advanced inoperable disease (Clinical assessment)
  • Relapse of gastric cancer
  • Malignant secondary disease
  • Known contraindications or hypersensitivity for planned chemotherapy

Other

  • Distant metastases (including retroperitoneal lymph node)
  • Inclusion in another clinical trial

Who the study is looking for

  • 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

Age in the registry: 76 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.