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MR-guided Pre-operative RT in Gastric Cancer

Primary Purpose

Gastric Adenocarcinoma

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MR guided radiation therapy
Blood for ctDNA
Standard of care chemotherapy regimen
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Washington University School of MedicineRecruiting
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Preoperative MR-guided Radiation Therapy

Arm Description

Radiotherapy of 5 fractions, delivered once daily, to a total dose of 25 Gy at 5 Gy per fraction. Radiation must be delivered with MR guided radiation therapy (MRgRT) and daily adaptive planning. Chemotherapy will be given as per standard of care. It should begin 2 to 4 weeks after completion of radiotherapy. Standard of care gastrectomy or esophagogastrectomy within 2-4 weeks following completion of chemotherapy Patients who are unable to complete their total neoadjuvant therapy regimen may complete the chemotherapy postoperatively, at the discretion of the treating physician. Postoperative chemotherapy should start within 3 months of surgery. Patients who are medically inoperable will continue to receive chemotherapy until the entire regimen is complete.

Outcomes

Primary Outcome Measures

Complete pathologic response (pCR - primary and nodal) rate
pCR: no pathological signs of cancer

Secondary Outcome Measures

Local control rate
Local control from the time of gastrectomy
Rate of grade 3 or greater toxicity as defined by CTCAE version 5.0
Overall survival
-Overall survival from registration on trial
Disease-free survival
-Disease free means no locoregional and distant recurrence
Proportion of patients able to complete a full course of total neoadjuvant chemotherapy

Full Information

First Posted
November 11, 2019
Last Updated
October 6, 2023
Sponsor
Washington University School of Medicine
Collaborators
Viewray Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04162665
Brief Title
MR-guided Pre-operative RT in Gastric Cancer
Official Title
MR-guided Pre-operative RT in Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2020 (Actual)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
April 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Viewray Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative MR-guided Radiation Therapy
Arm Type
Experimental
Arm Description
Radiotherapy of 5 fractions, delivered once daily, to a total dose of 25 Gy at 5 Gy per fraction. Radiation must be delivered with MR guided radiation therapy (MRgRT) and daily adaptive planning. Chemotherapy will be given as per standard of care. It should begin 2 to 4 weeks after completion of radiotherapy. Standard of care gastrectomy or esophagogastrectomy within 2-4 weeks following completion of chemotherapy Patients who are unable to complete their total neoadjuvant therapy regimen may complete the chemotherapy postoperatively, at the discretion of the treating physician. Postoperative chemotherapy should start within 3 months of surgery. Patients who are medically inoperable will continue to receive chemotherapy until the entire regimen is complete.
Intervention Type
Radiation
Intervention Name(s)
MR guided radiation therapy
Other Intervention Name(s)
MRgRT
Intervention Description
-Image-based treatment planning and intensity modulated radiotherapy (IMRT) is permitted.
Intervention Type
Procedure
Intervention Name(s)
Blood for ctDNA
Intervention Description
-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
Intervention Type
Drug
Intervention Name(s)
Standard of care chemotherapy regimen
Intervention Description
The recommendations are CAPOX, FOLFOX, or FLT.
Primary Outcome Measure Information:
Title
Complete pathologic response (pCR - primary and nodal) rate
Description
pCR: no pathological signs of cancer
Time Frame
At the time of surgery (approximately 4.5 months)
Secondary Outcome Measure Information:
Title
Local control rate
Description
Local control from the time of gastrectomy
Time Frame
1 year
Title
Rate of grade 3 or greater toxicity as defined by CTCAE version 5.0
Time Frame
From baseline through 12 months after surgery/definitive end of treatment (estimated to be 16.5 months)
Title
Overall survival
Description
-Overall survival from registration on trial
Time Frame
1 year
Title
Disease-free survival
Description
-Disease free means no locoregional and distant recurrence
Time Frame
1 year
Title
Proportion of patients able to complete a full course of total neoadjuvant chemotherapy
Time Frame
Through completion of neoadjuvant chemotherapy (estimated to be 4.5 months)
Other Pre-specified Outcome Measures:
Title
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)
Title
Average percent difference in coverage of planning target volume (PTV) by 95% isodose line
Time Frame
Completion of radiation therapy (up to 2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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 T1-3N0-2 are eligible. Patients with N3, or T4 disease are not eligible. Known T-stage defined by EUS. Must have had CT of the chest/abdomen/pelvis with contrast. Medically eligible to receive standard of care 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 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 that would alter the radiation treatment field or stomach motion. Siewert I-II GE junction tumor Any active malignancy within 2 years of enrollment 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. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to chemotherapeutic 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 that are considered clinically significant as determined by the treating physician. 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Kim, M.D.
Phone
314-362-8502
Email
kim.hyun@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Kim, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun Kim, M.D.
Phone
314-362-8502
Email
kim.hyun@wustl.edu
First Name & Middle Initial & Last Name & Degree
Hyun Kim, M.D.
First Name & Middle Initial & Last Name & Degree
Ryan Fields, M.D.
First Name & Middle Initial & Last Name & Degree
Katrina Pedersen, M.D.
First Name & Middle Initial & Last Name & Degree
William Hawkins, M.D.
First Name & Middle Initial & Last Name & Degree
Pamela Samson, M.D.
First Name & Middle Initial & Last Name & Degree
Carl DeSelm, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Kian-Huat Lim, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Rama Suresh, M.D.
First Name & Middle Initial & Last Name & Degree
Benjamin Tan, M.D.
First Name & Middle Initial & Last Name & Degree
Patrick Grierson, M.D.
First Name & Middle Initial & Last Name & Degree
Dominic Sanford, M.D.
First Name & Middle Initial & Last Name & Degree
Natasha Leigh, M.D.
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eui Kyu Chie, M.D., Ph.D.
Phone
82-2-2072-3705
Email
ekchie93@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Eui Kyu Chie, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Han-Kwang Yang, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Do-Youn Oh, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Tae-Yong Kim, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Hyun-Cheol Kang, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Seong-Ho Kong, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Hyuk-Joon Lee, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Do-Joong Park, M.D., Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in the journal publication, after deidentification (text, tables, figures, and appendices)
IPD Sharing Time Frame
Beginning 9 months and ending ending 36 months following publication
IPD Sharing 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.
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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MR-guided Pre-operative RT in Gastric Cancer

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