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Preoperative MR-Guided Radiation Therapy in Gastric Cancer

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ClinicalTrials.gov Identifier: NCT04162665
Recruitment Status : Recruiting
First Posted : November 14, 2019
Last Update Posted : August 26, 2020
Sponsor:
Collaborator:
Viewray Inc.
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Gastric cancer is a global health issue as the world's fifth most common malignancy and third leading cause of cancer mortality, respectively. Preoperative radiation therapy may improve overall survival (OS) but is seldom used. There is precedent for preoperative chemoradiation, as it is the standard of care for esophageal and gastroesophageal junction tumors. However, reluctance of physicians to prescribe preoperative radiation therapy in gastric cancer may be due to the large treatment fields necessary to account for stomach motion. MR guided radiation therapy (MRgRT) may permit decreased field sizes and more accurate dose delivery. In traditional CT based radiation delivery the same radiation plan is delivered each day without assessment of inter-fraction or intra-fraction motion. MRgRT permits the physician to contour the unique anatomy daily to generate a new plan to account for day to day organ motion. Real-time MR imaging is also used during the treatment so that radiation is only delivered when the tumor is within the pre-specified target area. Thus, MRgRT may overcome traditional barriers of radiation delivery in gastric cancer and improve oncologic outcomes.

Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Radiation: MR guided radiation therapy Procedure: Blood for ctDNA Not Applicable

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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: Preoperative MR-Guided Radiation Therapy to Improve Oncologic Outcomes in Gastric Cancer
Actual Study Start Date : February 14, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Preoperative MR-guided Radiation Therapy
  • Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25 Gy at 5 Gy per fraction. The clinical target volume will include the entire stomach and locoregional lymph nodes. Radiation must be delivered with MR guided radiation therapy (MRgRT) and daily adaptive planning. The stomach and OARs must be redrawn each day for the adaptive plan. Plans should be adapted to meet OAR constraints or improve coverage as needed for each day's unique anatomy
  • (5) 21-day cycles of standard of care CAPOX chemotherapy following completion of radiation
  • Standard of care gastrectomy or esophagogastrectomy following completion of chemotherapy
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




Primary Outcome Measures :
  1. Complete pathologic response (pCR) rate [ Time Frame: At the time of surgery (approximately 20 weeks) ]
    -pCR: no pathological signs of cancer


Secondary Outcome Measures :
  1. 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) ]
  2. Local control rate [ Time Frame: 1 year ]
    -Local control from the time of gastrectomy

  3. 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) ]
  4. Overall survival [ Time Frame: 1 year ]
    -Overall survival from registration on trial

  5. Average percent difference in coverage of planning target volume (PTV) by 95% isodose line [ Time Frame: Completion of radiation therapy (up to 2 weeks) ]
  6. Disease-free survival [ Time Frame: 1 year ]
    -Disease free means no locoregional and distant recurrence



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 and T3Nx disease are eligible (stage I-III). Patients with T2N0, N3, T4, M1 or T1N0 disease are not eligible.
  • T-stage defined by EUS. Must have had CT of the chest/abdomen/pelvis with oral and IV contrast.
  • Medically eligible to receive CAPOX chemotherapy
  • At least 18 years of age (per US calculation 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).

Information from the National Library of Medicine

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


Contacts
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Contact: Hyun Kim, M.D. 314-362-8502 kim.hyun@wustl.edu

Locations
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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: Justin Park, Ph.D.         
Sub-Investigator: Olga Green, Ph.D.         
Sub-Investigator: Andrea Wang-Gillam, M.D., Ph.D.         
Sub-Investigator: Devali Chatterjee, M.D.         
Korea, Republic of
Seoul National University College of Medicine 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.         
Sponsors and Collaborators
Washington University School of Medicine
Viewray Inc.
Investigators
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Principal Investigator: Hyun Kim, M.D. Washington University School of Medicine
Additional Information:
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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: August 26, 2020
Last Verified: August 2020
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.

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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
Additional relevant MeSH terms:
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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