MR-guided Pre-operative RT in Gastric Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04162665 |
Recruitment Status :
Recruiting
First Posted : November 14, 2019
Last Update Posted : March 16, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Adenocarcinoma | Radiation: MR guided radiation therapy Procedure: Blood for ctDNA | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | MR-guided Pre-operative RT in Gastric Cancer |
Actual Study Start Date : | February 14, 2020 |
Estimated Primary Completion Date : | July 31, 2024 |
Estimated Study Completion Date : | February 28, 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: Preoperative MR-guided Radiation Therapy
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Radiation: MR guided radiation therapy
-Image-based treatment planning and intensity modulated radiotherapy (IMRT) is permitted.
Other Name: MRgRT Procedure: Blood for ctDNA -Prior to start of radiation, after the completion of radiation therapy and prior to starting chemotherapy (2-4 weeks after radiation completion), at the completion of chemotherapy and prior to surgery (2-4 weeks after chemotherapy completion), and 6 months after surgery |
- Complete pathologic response (pCR - primary and nodal) rate [ Time Frame: At the time of surgery (approximately 20 weeks) ]-pCR: no pathological signs of cancer
- Average percentage difference in dose to nearby organs at risk (OARs) due to variation in OAR position [ Time Frame: Completion of radiation therapy (up to 2 weeks) ]
- Local control rate [ Time Frame: 1 year ]-Local control from the time of gastrectomy
- Rate of grade 3 or greater toxicity as defined by CTCAE version 5.0 [ Time Frame: From baseline through 12 months after the end of treatment (approximately 73 weeks) ]
- Overall survival [ Time Frame: 1 year ]-Overall survival from registration on trial
- Average percent difference in coverage of planning target volume (PTV) by 95% isodose line [ Time Frame: Completion of radiation therapy (up to 2 weeks) ]
- Disease-free survival [ Time Frame: 1 year ]-Disease free means no locoregional and distant recurrence

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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Newly diagnosed histologically or cytologically gastric adenocarcinoma. (Siewert III acceptable: the bulk of tumor should be in stomach; gastric tumors with extension to the gastroesophageal junction are permitted.) Patients with T1-T2N1-2 and T3N0-2 disease are eligible (stage I-III). Patients with T1-2N0, N3, T4, or M1 disease are not eligible.
- T-stage defined by EUS. Must have had CT of the chest/abdomen/pelvis with contrast.
- Medically eligible to receive CAPOX chemotherapy
- At least 19 years of age
- ECOG performance status ≤ 2
Normal bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1,500 cells/mm3
- Platelets ≥ 100,000 cells/mm3
- Hemoglobin > 9 g/dL
-
Creatinine clearance > 50 mL/min
- The effects of the various chemotherapy agents used in this study on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and one month after completion of the study
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
- Prior surgery, radiation, or chemotherapy for gastric or esophageal cancer.
- Prior surgery to the esophagus or stomach.
- Siewert I-II GE junction tumor
- Any active malignancy within 2 years that may alter the course of gastric cancer. (Apparently cured localized malignancy or advanced, but indolent malignancy with significantly more favorable prognosis are allowed).
- Currently receiving any other investigational agents.
- Metastatic disease, including gross peritoneal carcinoma
- Presence of ascites
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine, oxaliplatin, or other agents used in the study.
- Contraindications to MRI (e.g., non-compatible implantable device or metallic foreign bodies).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended. Recommend exclusion of specific ART agents based on predicted drug-drug interactions (i.e. for sensitive CYP3A4 substrates, concurrent strong CYP3A4 inhibitors (ritonavir and cobicistat) or inducers (efavirenz) should be contraindicated).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04162665
Contact: Hyun Kim, M.D. | 314-362-8502 | kim.hyun@wustl.edu |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Hyun Kim, M.D. 314-362-8502 kim.hyun@wustl.edu | |
Principal Investigator: Hyun Kim, M.D. | |
Sub-Investigator: Ryan Fields, M.D. | |
Sub-Investigator: Haeseong Park, M.D. | |
Sub-Investigator: Katrina Pedersen, M.D. | |
Sub-Investigator: Lauren Henke, M.D. | |
Sub-Investigator: Shahed Badiyan, M.D. | |
Sub-Investigator: William Hawkins, M.D. | |
Sub-Investigator: Olga Green, Ph.D. | |
Sub-Investigator: Pamela Samson, M.D. | |
Sub-Investigator: Carl DeSelm, M.D., Ph.D. | |
Sub-Investigator: Kian-Huat Lim, M.D., Ph.D. | |
Sub-Investigator: Rama Suresh, M.D. | |
Sub-Investigator: Benjamin Tan, M.D. | |
Sub-Investigator: Patrick Grierson, M.D. | |
Korea, Republic of | |
Seoul National University Hospital | Not yet recruiting |
Seoul, Korea, Republic of | |
Contact: Eui Kyu Chie, M.D., Ph.D. 82-2-2072-3705 ekchie93@snu.ac.kr | |
Principal Investigator: Eui Kyu Chie, M.D., Ph.D. | |
Sub-Investigator: Han-Kwang Yang, M.D., Ph.D. | |
Sub-Investigator: Do-Youn Oh, M.D., Ph.D. | |
Sub-Investigator: Tae-Yong Kim, M.D., Ph.D. | |
Sub-Investigator: Hyun-Cheol Kang, M.D., Ph.D. | |
Sub-Investigator: Seong-Ho Kong, M.D., Ph.D. | |
Sub-Investigator: Hyuk-Joon Lee, M.D., Ph.D. | |
Sub-Investigator: Do-Joong Park, M.D., Ph.D. |
Principal Investigator: | Hyun Kim, M.D. | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT04162665 |
Other Study ID Numbers: |
201911059 |
First Posted: | November 14, 2019 Key Record Dates |
Last Update Posted: | March 16, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Individual participant data that underlie the results reported in the journal publication, after deidentification (text, tables, figures, and appendices) |
Supporting Materials: |
Study Protocol |
Time Frame: | Beginning 9 months and ending ending 36 months following publication |
Access Criteria: | Investigators whose proposed use of the data has been approved by the Washington University School of Medicine IRB. The data will be available for individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Adenocarcinoma Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |