Clinical trial · Interventional
Fluorouracil, Cisplatin, Cetuximab, and Radiation Therapy in Treating Patients With Esophageal Cancer That Can Be Removed by Surgery
Neoadjuvant Treatment for Operable Esophageal Cancer With 5-fluorouracil, Cisplatin, and Cetuximab and Concurrent Radiotherapy: Phase I/II Study
- 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 and cisplatin, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving fluorouracil and cisplatin together with cetuximab and radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of fluorouracil and cisplatin when given together with cetuximab and radiation therapy in treating patients with esophageal cancer that can be removed by surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Biological | Cetuximab | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant chemoradiotherapy
- description
- Weekly cetuximab (400 mg/m2 one week before start of radiotherapy RT and 250 mg/m2 during radiotherapyRT), and 5 FU (500 mg/m2 per day D1-D4) combined with cisplatin CDDP (40 mg/m2 D1) on week 1 and 5
- interventionNames
- Biological: cetuximab
- Drug: cisplatin
- Drug: fluorouracil
- Procedure: conventional surgery
Primary outcomes (2)
- measure
- Complete histologic response
- timeFrame
- After Surgery
- measure
- Tolerance to neoadjuvant therapy
- timeFrame
- From Inclusion
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically confirmed epidermoid or glandular carcinoma of the thoracic esophagus * Invasive disease * Only Siewert type I gastroesophageal carcinoma allowed * Resectable disease * T1N+, T2N0, T2N+, T3N0, or T3N+ (stage II or III) * No visceral metastases or mediastinal extensions compromising resectability Exclusion criteria: * Inoperable disease * Invasion of the tracheo-bronchial tree * Recurring esophageal paralysis * Esopho-tracheal fistula * Cervical esophageal carcinoma (\< 19 cm above the dental arches) * Multifocal esophageal carcinoma * Superficial esophageal carcinoma (T1N0) * Esophageal carcinoma in the lymph nodes that cannot be included in the radiotherapy field or cannot be completely surgically resected * Proven metastatic disease PATIENT CHARACTERISTICS: Inclusion criteria: * WHO performance status 0-1 * Weight loss \< 15% * Absolute neutrophil count ≥ 1,500/mm3 * Platelet count ≥ 100,000/mm3 * Creatinine ≤ 1.25 times upper limit of normal * PTT ≥ 80% * Albumin ≥ 35 g/L * FEV1 \> 1 L * Not pregnant or nursing * Fertile patients of must use effective contraception Exclusion criteria: * Known liver cirrhosis * Renal insufficiency * Respiratory insufficiency (i.e., severe dyspnea at rest or oxygen dependence) * Progressive coronary insufficiency * Myocardial infarction in the past 6 months * Legally incapacitated * Impossible to receive study therapy due to geographical, social, or psychological reasons * Noncompliant within constraints of the study * Hematologic malignancy or other cancer except carcinoma in situ of the uterine cervix, treated nonmelanoma skin cancer, or intramucous disease treated within the past 3 years PRIOR CONCURRENT THERAPY: Exclusion criteria: * Prior anticancer chemotherapy or radiotherapy * Treatment with endoprosthesis * Surgery (esophagectomy) planned without thoracotomy
References
Publications (0)
Data not yet available