Not yet recruiting NCT07101666
Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Short course radiation therapy, Standard of care neoadjuvant chemotherapy.
- Who it may be relevant to
- Registry conditions: Gastric Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Standard treatment for patients with early stage gastric cancer consists of perioperative chemotherapy and surgical resection. If radiation therapy is administered in the adjuvant setting, the radiated area is often large and associated with significant toxicity. In this study, the investigators propose the addition of short course radiation therapy (SCRT) to chemotherapy in the neoadjuvant setting. The investigators hypothesize that this regimen of Total Neoadjuvant Therapy (TNT) will result in a higher rate of complete response (both pathologic and clinical), with less toxicity.
Interventions
- Radiation Short course radiation therapy
25 Gy in 5 fractions - Drug Standard of care neoadjuvant chemotherapy
Recommended options are CAPOX, FOLFOX, or FLOT but other standard of care chemotherapy may be given given at the discretion of the treating medical oncologist after consultation with the study Principal Investigator.
Primary outcome measures
- Complete response (CR) rate [Time frame: Through completion of surgery (estimated to be 6 months) for operable patients or through 12 months after end of treatment for inoperable patients (estimated to be 18 months)]
Secondary outcome measures (1)
- Rate of grade 3 or greater adverse events as defined by CTCAE v 5.0 [Time frame: From day 1 of SCRT through 12 months after surgery/definitive end of treatment (estimated to be 18 months)]
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 T1-4N0-3 are eligible.
- Known T-stage defined by EUS. Must have had CT of the chest/abdomen/pelvis with IV contrast (or PET/CT if unable to receive iodinated contrast).
- Medically eligible to receive SOC chemotherapy.
- At least 18 years of age.
- ECOG performance status ≤ 2.
- Adequate bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1.5 K/cumm
- Platelets ≥ 100 K/cumm
- Creatinine clearance > 50 mL/min by Cockroft Gault calculation
- 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. Legally authorized representatives may sign and give informed consent on behalf of study participants.
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.
- Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
- Currently receiving any other investigational agents.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to the SOC chemotherapy used in the study.
- Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, 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 serum or urine pregnancy test within 14 days of study entry.
- HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- UCLA — Los Angeles
- Moffitt Cancer Center — Tampa
- Dana Farber Cancer Institute — Boston
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT07101666 · 25-x143