Gastric AdenocarcinomaPhase 2NCT04162665
Pre-operative Adaptive Short Court Radiation Therapy in Gastric Cancer
A Phase 2 study testing Adaptive short course radiation therapy in people with Gastric Adenocarcinoma, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- Adaptive short course radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2020to 21 Nov 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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).
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Pre-operative Adaptive Short Course Radiation Therapy in Gastric Cancer
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
- Being tested
- Adaptive short course radiation therapy, Standard of care chemotherapy regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive short course radiation therapyRadiation
Radiation must be livered with adaptive planning and MR gating or CBCT breath hold treatment.
Standard of care chemotherapy regimenDrug
The recommendations are CAPOX, FOLFOX, or FLT.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Adaptive short course radiation therapy; Drug: Standard of care chemotherapy regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Pathologic Response (pCR - Primary and Nodal) Rate
pCR: no pathological signs of cancer
Measured: At the time of surgery (approximately 4.5 months)
Secondary outcomes (5)
Number of Participants With Local Control
Local control calculated from start of radiation.
Measured: At 1 year post radiation
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
Measured: From baseline through 12 months after surgery/definitive end of treatment (estimated to be 16.5 months)
Overall Survival
-Overall survival from start of radiation.
Measured: At 1 year post radiation
Number of Participants With Disease-free Survival
-Disease free means no locoregional and distant recurrence
Measured: At 1 year post radiation
Number of Patients Able to Complete a Full Course of Total Neoadjuvant Chemotherapy
Measured: Through completion of neoadjuvant chemotherapy (estimated to be 4.5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start14 Feb 2020
- Primary completion18 Dec 2023
- Study completion21 Nov 2024
Why it stopped: Poor accrual and funding sponsor declared bankruptcy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Viewray Inc.
- Responsible party
- Sponsor
- Investigators
- Hyun Kim, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162665
- Sponsor's protocol ID
- 201911059
- Status last verified
- Dec 2024
- First submitted
- 11 Nov 2019
- Last updated
- 9 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the journal publication, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Adaptive Short Course Radiation Therapy in Gastric Cancer
- ClinicalTrials.gov ID
- NCT04162665
- Acronym / sponsor ID
- 201911059
- Conditions
- Gastric Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual and funding sponsor declared bankruptcy.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Viewray Inc.
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 21 Nov 2024 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Posted 9 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-operative adaptive short course radiation therapy | Experimental | Radiation: Adaptive short course radiation therapy, Drug: Standard of care chemotherapy regimenConsenting 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive short course radiation therapyRadiation must be livered with adaptive planning and MR gating or CBCT breath hold treatment. | Radiation | Pre-operative adaptive short course radiation therapy |
| Standard of care chemotherapy regimenThe recommendations are CAPOX, FOLFOX, or FLT. | Drug | Pre-operative adaptive short course radiation therapy |
Primary outcome
Complete Pathologic Response (pCR - Primary and Nodal) Rate
Time frame: At the time of surgery (approximately 4.5 months)
pCR: no pathological signs of cancer
5 secondary outcomes
Number of Participants With Local Control
Time frame: At 1 year post radiation
Number 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)
Overall Survival
Time frame: At 1 year post radiation
Number of Participants With Disease-free Survival
Time frame: At 1 year post radiation
Number 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the journal publication, after deidentification (text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun Kim, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adaptive short course radiation therapy in people with Gastric Adenocarcinoma, run by Washington University School of Medicine 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 11 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: stopped early, as of the sponsor's last update on 9 Jan 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Complete Pathologic Response (pCR - Primary and Nodal) Rate (time frame: At the time of surgery (approximately 4.5 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2025.