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Can adding radiation before surgery help stomach cancer patients live longer?

NCT ID NCT03013010

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

204 people

The number who actually took part.

Started

Dec 2016

Finished

Dec 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • 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.