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Clinical Stage I Gastric Cancer AJCC v8Phase 1NCT04523818

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

A Phase 1 study testing Capecitabine, Fluorouracil and Radiation Therapy in people with Clinical Stage I Gastric Cancer AJCC v8 and Clinical Stage IIA Gastric Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Capecitabine, Fluorouracil and Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
11 Aug 2020to 31 Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess the safety and tolerability of preoperative short-course chemoradiotherapy (CXRT) in patients with potentially resectable gastric adenocarcinoma.

SECONDARY OBJECTIVES:

  1. 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.

Being tested
Capecitabine, Fluorouracil, Radiation Therapy, Therapeutic Surgical Procedure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    Also called Ro 09-1978/000, Xeloda

    Given PO

  • FluorouracilDrug

    Also called 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione

    Given IV

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Irradiate, Irradiated, Irradiation

    Undergo radiation therapy

  • Therapeutic Surgical ProcedureProcedure or surgery

    Undergo standard of care surgery

Study groups in NCT04523818
Study groupRoleWhat they receive
Treatment (CXRT, chemotherapy, surgery)ExperimentalPatients 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.
Receives: Drug: Capecitabine; Drug: Fluorouracil; Radiation: Radiation Therapy; Procedure: Therapeutic Surgical Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    Characterized by the incidence and severity of treatment-related adverse events. Grade 3 or higher toxicity classified as attributable to chemotherapy and radiation treatment (CXRT), during the 14 days of treatment administration or within 14 days of completion of CXRT (i.e., a total of 28 days), based on multidisciplinary review, will be used for the purpose of toxicity monitoring. Differences between grades vary and are detailed according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. In general, Grade 3 toxicity refers to any event that requires hospitalization with intervention (i.e., intravenous [IV] hydration, symptomatic control, transfusion, procedure, etc.).

    Measured: Up to 4 weeks following last chemotherapy

Secondary outcomes (3)

  1. Rate of pathologic complete response in patients treated with resection

    Will be estimated, along with exact 95% confidence intervals.

    Measured: Up to 5 years

  2. Rate of perioperative complications after gastrectomy in patients treated with preoperative short course CXRT and chemotherapy

    Will be estimated, along with exact 95% confidence intervals.

    Measured: Up to 5 years

  3. Overall survival (OS)

    Will be evaluated using the Kaplan-Meier method. Median OS and the 95% confidence interval will be reported.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2020
  2. Study start11 Aug 2020
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04523818
Sponsor's protocol ID
2020-0481
Other IDs
NCI-2020-05810, 2020-0481
Status last verified
Jul 2026
First submitted
18 Aug 2020
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Capecitabine, Fluorouracil and Radiation Therapy in people with Clinical Stage I Gastric Cancer AJCC v8 and Clinical Stage IIA Gastric Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: Up to 4 weeks following last chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04523818.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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