Radiation before surgery may boost chemo for Stomach-Esophagus cancer
NCT ID NCT04375605
First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether adding radiation to chemotherapy before surgery helps people with a certain type of stomach-esophagus cancer live longer without the disease returning. About 342 adults with locally advanced but potentially removable cancer will receive either chemotherapy alone or chemotherapy plus radiation before surgery. The study aims to see which approach better prevents cancer progression or recurrence.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FLOT chemotherapy (5-fluorouracil, calcium folinate, oxaliplatin, docetaxel) plus radiation
- What this could lead to
- If adding radiation to chemotherapy before surgery improves outcomes, this could become a new standard treatment for this type of cancer.
- What could go wrong
- This is an early-stage comparison; adding radiation may increase side effects without clear benefit. Results may not apply to all patients.
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
-
342 people
The number who actually took part.
- Started
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Jun 2020
- Finished
-
Jun 2026
- 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
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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 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: 1. Histologically proven, locally advanced and potentially resectable adenocarcinoma of the gastroesophageal junction (GEJ) (Siewert I- III) that is: cT3-4, any N, M0 or cT2 N+, M0 according to AJCC 8th edition 2. Patients\* must be candidates for potential curative resection as determined by the treating surgeon 3. ECOG performance status 0-1 4. Age 18 years or above 5. Adequate hematologic function with absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/l, platelets ≥ 100 x 10\^9/l and hemoglobin ≥ 9.0 mg/dl 6. INR \<1.5 and aPTT\<1.5 x upper limit of normal (ULN) within 7 days prior to randomization 7. Adequate liver function as measured by serum transaminases (ASAT, ALAT) ≤ 2.5 x ULN and total bilirubin ≤ 1.5 x ULN 8. Adequate renal function with serum creatinine ≤ 1.5 x ULN 9. QTc interval (Bazett\*) ≤ 440 ms 10. Written informed consent obtained before randomization 11. Negative pregnancy test for women of childbearing potential within 7 days of commencing study treatment. Males and females of reproductive potential must agree to practice highly effective\*\*\* contraceptive measures during the study and for 6 months after the end of study treatment. Male patients must also agree to refrain from father a child during treatment and up to 6 months afterwards and additionally to use a condom during treatment period. Their female partner of childbearing potential must also agree to use an adequate contraceptive measure. * \*There are no data that indicate special gender distribution. Therefore, patients will be enrolled in the study gender-independently. * \*\* formula for QTc interval calculation (Bazett): QTc= ((QT) ̅" (ms)" )/√(RR (sec))= ((QT) ̅" (ms)" )/√(60/(Frequence (1/min))) * \*\*\* highly effective (i.e. failure rate of \<1% per year when used consistently and correctly) methods: intravaginal and transdermal combined (estrogen and progestogen containing) hormonal contraception; injectable and implantable progestogen-only hormonal contraception; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence (complete abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments). Exclusion Criteria: 1. Evidence of metastatic disease (exclusion of distant metastasis by CT of thorax and abdomen, bone scan or MRI \[if osseous lesions are suspected due to clinical signs\]) 2. Past or current history (within the last 5 years prior to treatment start) of other malignancies. Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible 3. Evidence of peripheral sensory neuropathy \> grade 1 according to CTCAE version 4.03 4. Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled 5. Pregnant or lactating females 6. Patients medically unfit for chemotherapy and radiotherapy 7. Patients receiving any immunotherapy, cytotoxic chemotherapy or radiotherapy other than defined by the protocol. The participation in another clinical trial with the use of investigational agents, chemotherapy or radiotherapy during the trial is not permitted 8. Known hypersensitivity against 5-FU, folinc acid, oxaliplatin or docetaxel 9. Other known contraindications against 5-FU, folinic acid, oxaliplatin, or docetaxel 10. Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV 11. Clinically significant valvular defect 12. Other severe internal disease or acute infection 13. Peripheral polyneuropathy \> NCI Grade II according to CTCAE version 4.03 14. Chronic inflammatory bowel disease
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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
-
Unversity Hospital Mannheim
Mannheim, 68167, Germany
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