Short-Course Chemoradiotherapy Followed by Chemotherapy for the Treatment of Resectable Gastric Adenocarcinoma

NCT04523818 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-14

No results posted yet for this study

Summary

This phase Ib trial investigates the side effects and how well a shorter course of chemotherapy and radiation treatment (chemoradiotherapy) for 2 weeks instead of 5 weeks followed by standard chemotherapy works in treating patients with gastric cancer who are scheduled to have treatment and then surgery to remove the tumor. Chemotherapy drugs, such as capecitabine and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy sources to kill tumor cells and shrink tumors. Giving short-course chemo-radiotherapy before chemotherapy and surgery may help to control the disease.

Conditions

  • Clinical Stage I Gastric Cancer AJCC v8
  • Clinical Stage IIA Gastric Cancer AJCC v8
  • Clinical Stage III Gastric Cancer AJCC v8
  • Clinical Stage IVA Gastric Cancer AJCC v8
  • Gastric Adenocarcinoma
  • Pathologic Stage IB Gastric Cancer AJCC v8
  • Pathologic Stage II Gastric Cancer AJCC v8
  • Pathologic Stage IIA Gastric Cancer AJCC v8
  • Pathologic Stage IIB Gastric Cancer AJCC v8
  • Pathologic Stage III Gastric Cancer AJCC v8
  • Pathologic Stage IIIA Gastric Cancer AJCC v8
  • Pathologic Stage IIIB Gastric Cancer AJCC v8
  • Pathologic Stage IIIC Gastric Cancer AJCC v8
  • Postneoadjuvant Therapy Stage I Gastric Cancer AJCC v8
  • Postneoadjuvant Therapy Stage II Gastric Cancer AJCC v8
  • Postneoadjuvant Therapy Stage III Gastric Cancer AJCC v8

Interventions

DRUG

Capecitabine

Given PO

DRUG

Fluorouracil

Given IV

RADIATION

Radiation Therapy

Undergo radiation therapy

PROCEDURE

Therapeutic Surgical Procedure

Undergo standard of care surgery

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Brian D Badgwell · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-11
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04523818 on ClinicalTrials.gov