Short-Course Chemoradiotherapy Followed by Chemotherapy for the Treatment of Resectable Gastric Adenocarcinoma
NCT ID: NCT04523818
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
25 participants
INTERVENTIONAL
2020-08-11
2028-12-31
Brief Summary
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Detailed Description
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I. To assess the safety and tolerability of preoperative short-course chemoradiotherapy (CXRT) in patients with potentially resectable gastric adenocarcinoma.
SECONDARY OBJECTIVES:
I. To assess the rate of pathologic complete response (pathCR) in patients treated with preoperative short-course CXRT.
II. To assess the rate of perioperative complications after gastrectomy in patients treated with preoperative short-course CXRT.
III. To assess overall survival from the date of diagnosis in subjects treated with short course CXRT.
OUTLINE:
Patients receive CXRT consisting of radiation therapy 5 days a week (Monday through Friday) for 2 weeks (10 treatments) and standard of care chemotherapy consisting of capecitabine orally (PO) twice daily (BID) or fluorouracil intravenously (IV) continuous Monday to Friday of each radiation week. About 2 weeks later, patients receive standard of care chemotherapy for up to 2 months in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery 3-8 weeks post-chemotherapy completion.
After the completion of study treatment, patients are followed up every 6 months for 5 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (CXRT, chemotherapy, surgery)
Patients receive CXRT consisting of radiation therapy 5 days a week (Monday through Friday) for 2 weeks (10 treatments) and standard of care chemotherapy consisting of capecitabine PO BID or fluorouracil IV continuous Monday to Friday of each radiation week. About 2 weeks later, patients receive standard of care chemotherapy for up to 2 months in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery 3-8 weeks post-chemotherapy completion.
Capecitabine
Given PO
Fluorouracil
Given IV
Radiation Therapy
Undergo radiation therapy
Therapeutic Surgical Procedure
Undergo standard of care surgery
Interventions
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Capecitabine
Given PO
Fluorouracil
Given IV
Radiation Therapy
Undergo radiation therapy
Therapeutic Surgical Procedure
Undergo standard of care surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
* Subjects with unstable angina or New York Heart Association grade II or greater congestive heart failure
* Subjects deemed unable to comply with study and/or follow-up procedures
* 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
* Prior radiotherapy to the same field
* Comorbid conditions (examples - collagen vascular diseases, certain genetic conditions that predispose to secondary malignancies) that are prohibitive to preoperative therapy, or contraindications to radiotherapy
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Brian D Badgwell
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2020-05810
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-0481
Identifier Type: OTHER
Identifier Source: secondary_id
2020-0481
Identifier Type: -
Identifier Source: org_study_id
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