Pre-operative Adaptive Short Court Radiation Therapy in Gastric Cancer

NCT04162665 | Terminated Phase 2 Results DMC FDA Drug FDA Device

• 1 other identifier: 201911059
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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. Adaptive radiation therapy 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. Adaptive radiation therapy 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, adaptive radiation therapy may overcome traditional barriers of radiation delivery in gastric cancer and improve oncologic outcomes.

Conditions

Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Complete Pathologic Response (pCR - Primary and Nodal) Rate

  pCR: no pathological signs of cancer

  At the time of surgery (approximately 4.5 months)

Secondary Outcomes (5)

• Number of Participants With Local Control

  At 1 year post radiation

• Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0

  From baseline through 12 months after surgery/definitive end of treatment (estimated to be 16.5 months)

• Overall Survival

  At 1 year post radiation

• Number of Participants With Disease-free Survival

  At 1 year post radiation

• Number of Patients Able to Complete a Full Course of Total Neoadjuvant Chemotherapy

  Through completion of neoadjuvant chemotherapy (estimated to be 4.5 months)

Other Outcomes (2)

• Average Percentage Difference in Dose to Nearby Organs at Risk (OARs) Due to Variation in OAR Position

  Completion of radiation therapy (up to 2 weeks)

• Average Percent Difference in Coverage of Planning Target Volume (PTV) by 95% Isodose Line

  Completion of radiation therapy (up to 2 weeks)

Study Arms (1)

Pre-operative adaptive short course radiation therapy

EXPERIMENTAL

Consenting and eligible patients will receive adaptive short course radiation therapy (SCRT) (25 Gy at in 5 fractions), followed by standard of care total neoadjuvant chemotherapy followed by standard of care gastrectomy or esophagogastrectomy. The recommended SOC chemotherapy options are CAPOX, FOLFOX, or FLOT, but any SOC total neoadjuvant chemotherapy may be given at the discretion of the treating medical oncologist after consultation with the study chair. Patients who are not able to complete their full total neoadjuvant therapy regimen prior to surgery may complete chemotherapy postoperatively at the discretion of the treating physician.

Radiation: Adaptive short course radiation therapy; Drug: Standard of care chemotherapy regimen

Interventions

Adaptive short course radiation therapy RADIATION

Radiation must be livered with adaptive planning and MR gating or CBCT breath hold treatment.

Pre-operative adaptive short course radiation therapy

Standard of care chemotherapy regimen DRUG

The recommendations are CAPOX, FOLFOX, or FLT.

Pre-operative adaptive short course radiation therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Viewray Inc.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Limitations and Caveats

Due to the limited number of participants treated, the statistical analyses as stated in the protocol could not be performed.

Results Point of Contact

• Title: Hyun Kim, M.D.
• Organization: Washington University School of Medicine

kim.hyun@wustl.edu

314-362-8502

Study Officials

• Hyun Kim, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 14, 2019
• Study Start: February 14, 2020
• Primary Completion: December 18, 2023
• Study Completion: November 21, 2024
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)