Radiation before surgery may boost chemo for Stomach-Esophagus cancer

NCT ID NCT04375605

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

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: 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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