Fact CheckerSign in

NCT04523818Active, not recruitingPhase 1

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

A Phase Ib Trial of Preoperative Short-Course Chemoradiotherapy Followed by Chemotherapy for Resectable Gastric Adenocarcinoma

Source: ClinicalTrials.gov · Last updated 16 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
25 (actual)
First submitted
18 Aug 2020
Start date
11 Aug 2020
Primary completion date
31 Dec 2028
Lead sponsor
M.D. Anderson Cancer Center
NCT number
NCT04523818

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 25
  • From 11 Aug 2020 to the primary completion date, 31 Dec 2028
  • 1 site in 1 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

  • Presence of metastatic disease on staging with standard of care imaging, with or without diagnostic laparoscopy. Subjects not able to undergo staging laparoscopy due to previous surgery will not be excluded from this trial, and the determination of absence of metastatic disease will be decided solely on imaging consistent with our current standard of care
  • Prior radiotherapy to the same field

Other illness

  • Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract
  • Infections such as pneumonia or wound infections that would preclude protocol therapy
  • Subjects with unstable angina or New York Heart Association grade II or greater congestive heart failure
  • Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity
  • Comorbid conditions (examples - collagen vascular diseases, certain genetic conditions that predispose to secondary malignancies) that are prohibitive to preoperative therapy, or contraindications to radiotherapy

Lab values

  • Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 12 consecutive months) must agree to refrain from breast-feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, barrier methods, or abstinence. Contraception for males consists of barrier methods or abstinence

Other

  • Subjects deemed unable to comply with study and/or follow-up procedures

Who the study is looking for

  • Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
  • Patients with a biopsy-confirmed diagnosis of adenocarcinoma of the stomach
  • No evidence of distant metastatic disease based on standard of care preoperative imaging evaluation
  • Evidence of T2 stage or greater primary tumor, or any T stage with node positive disease based on endoscopic ultrasound or standard of care imaging
  • Leukocytes \>= 3,000/ul
  • Absolute neutrophil count \>= 1,500/ul
  • Platelets \>= 60,000/UI
  • Glomerular filtration rate \>= 60 mL/min/1.73 m\^2. The estimated glomerular filtration rate (eGFR) is calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. The eGFR declines with age. eGFR \< 60 mL/min/1.73 m2 is considered as "decreased". This equation should only be used for patients 18 and older. According to the National Kidney Foundation's Kidney Disease Outcome Quality Initiative (KDOQI) classification and 2012 Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline, the stage of CKD should be categorized based on estimated GFR

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
M D Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status

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