Can adding radiation before surgery help stomach cancer patients live longer?
NCT ID NCT03013010
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding radiation to chemotherapy before surgery improves outcomes for people with locally advanced stomach or gastroesophageal junction cancer. About 204 adults with operable tumors received either chemotherapy alone or chemotherapy plus radiation before surgery, followed by more chemotherapy after. The main goal was to see if the combination therapy helps keep cancer from coming back longer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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204 people
The number who actually took part.
- Started
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Dec 2016
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age \>=18 years * Female and male * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Life expectancy \>=6 months * Histologically proven adenocarcinoma of the stomach or gastroesophageal junction (GEJ) (excluding Siewert I) that is: Stage IIB (T3N1 only), IIIA (T2N3 not eligible), IIIB, and IIIC, i.e. T3 - T4a and node positive, or T4b and/ or node positive, according to American Joint Committee on Cancer (AJCC) 7th edition * Considered operable following initial staging investigations or after pre-operative therapy Disease which can be radically treated with radiotherapy to 45 Gy with standard fractionation * Adequate organ function defined as follows: * Bone marrow: Haemoglobin \>=90 g/L, Absolute neutrophil count (ANC) \>=1.5 x 109 /L, Platelet count \>=100 x 109 /L; Hepatic: Serum bilirubin \<=1.5 x upper limit of normal, aspartate aminotransferase (AST) and/or alanine transaminase (ALT) \<=2.5 x upper limit of normal; Renal: Serum creatinine \<=1.0 x upper limit of normal * Patients are willing to obey the treatment and provide blood and tissue specimens * Written informed consent obtained before randomization Exclusion Criteria: * Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures * Sexually active males or females refuse to practice contraception during the study until 30 days after end of study * Evidence of metastatic disease * Prior chemotherapy or radiotherapy * Patients with a past history of cancer in the 5 years before randomization except for the squamous or basal cell carcinoma of the skin that has been effectively treated, and carcinoma in situ of the cervix that has been treated by operation * Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled * Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease * Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, or congestive heart failure, or cardiac infarction within 6 months prior to study enrollment, or cardiac insufficiency * Concurrent severe infection * Severe gastrointestinal bleeding, gastrointestinal perforation * Unable to swallow * Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety * Known hypersensitivity reaction or metabolic disorder to S-1or oxaliplatin * Renal impairment (GFR \<=50ml/min) * Linitis plastica
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a platform trial match the right drug combo to each tumor?
- Can a new drug DM001 take on advanced solid tumors?