Clinical trial · Interventional
Fluorouracil, Cisplatin, Leucovorin Calcium, and Cetuximab in Treating Patients With Adenocarcinoma of the Stomach or Gastroesophageal Junction
Trial Evaluating the Efficacy and Tolerance of Perioperative Chemotherapy With 5FU-Cisplatin-Cetuximab in Adenocarcinomas of the Stomach and Gastroesophageal Junction. Phase II Single Arm, Multicenter.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) together with cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects of giving fluorouracil, cisplatin, and leucovorin calcium together with cetuximab and to see how well they work in treating patients with adenocarcinoma of the stomach or gastroesophageal junction.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Gastroesophageal Junction | Gastroesophageal Junction Adenocarcinoma | ALIAS | 0.90 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cetuximab | Biological | Cetuximab | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Perioperative CT with 5FU-Cisplatine-Cetuximab
- description
- 6 cycles of intravenous Cetuximab (500mg/m²), Cisplatine (50mg/m²) and LV5FU2s (folinic acid 400mg/m², 5FU bolus 400mg/m², and continuous infusion of 5FU 2400mg/m²) every 2 weeks. Surgery was planned 3-4 weeks after the end of neaodjuvant CT and postoperative CT, with the same regimen, planned for 6-8 weeks after surgery.
- interventionNames
- Biological: cetuximab
- Drug: cisplatin
- Drug: fluorouracil
- Drug: leucovorin calcium
- Procedure: adjuvant therapy
- Procedure: neoadjuvant therapy
- Procedure: quality-of-life assessment
- Procedure: therapeutic conventional surgery
Primary outcomes (2)
- measure
- Objective response rate according to RECIST V1.1 criteria
- timeFrame
- 3 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
* Stage IB, II, or III disease according to TNM classification OR type I, II, or III disease according to Siewert classification
* TNM: T1N1-3, T2N0-3, T3N0-3, or T4N0-3 (no T1N0 or M1)
* Disease considered operable with curative intent
* No gastric scirrhous carcinoma (linitis plastica)
* Forms with independent cells are not considered linitis
* Measurable disease according to RECIST V1.1
* No planned esophagectomy without thoracotomy in patients with adenocarcinoma of the gastroesophageal junction type I
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Polynuclear neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine clearance \> 50 mL/min
* Bilirubin \< 1.5 times normal
* Serum albumin \> 30 g/L
* Prothrombin time ≥ 80%
* FEV1 \> 1 L in case of thoracotomy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known cirrhosis
* No other progressive condition that has not been stabilized including the following:
* Hepatic failure
* Renal failure
* Respiratory failure
* NYHA class III-IV congestive heart failure
* Unstable angina
* Myocardial infarction in the past 6 months
* Significant arrhythmias in the past 12 months
* No recent weight loss exceeding 15%
* No interstitial pneumonia
* No other malignant tumor within the past 5 years except for basal cell skin carcinoma or cancer in situ of the cervix
* No psychological, familial, or geographical reasons that will preclude the patient being monitored regularly
* No persons deprived of liberty or under guardianship (Disability Act)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy or radiotherapy for gastric cancer
* No other concurrent anticancer treatment, immunotherapy, or hormone therapy
* No prior abdominal or thoracic radiotherapyReferences
Publications (2)
- RESULTMariette C, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Robb WB, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF. Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901. J Clin Oncol. 2014 Aug 10;32(23):2416-22. doi: 10.1200/JCO.2013.53.6532. Epub 2014 Jun 30. PMID 24982463
- DERIVEDGronnier C, Mariette C, Lepage C, Monterymard C, Jary M, Ferru A, Baconnier M, Adhoute X, Tavan D, Perrier H, Guerin-Meyer V, Lecaille C, Bonichon-Lamichhane N, Pillon D, Cojocarasu O, Egreteau J, D'journo XB, Dahan L, Locher C, Texereau P, Collet D, Michel P, Ben Abdelghani M, Guimbaud R, Muller M, Bouche O, Piessen G. Perioperative Cetuximab with Cisplatin and 5-Fluorouracil in Esogastric Adenocarcinoma: A Phase II Study. Cancers (Basel). 2023 Apr 6;15(7):2188. doi: 10.3390/cancers15072188. PMID 37046849