Clinical trial · Interventional
Study of LV5FU2 Versus FOLFOX for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma
A Randomized Phase II Study of Leucovorin, 5-fluorouracil With or Without Oxaliplatin (LV5FU2 vs. FOLFOX) for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma.
- 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)
Oxaliplatin is a platinum analogue that has significant antitumor activity with better tolerability than cisplatin. The objective of the study is to evaluate the safety and activity of leucovorin and 5-fluorouracil and leucovorin and 5-fluorouracil plus oxaliplatin combination chemotherapy given as adjuvant therapy for curatively-resected, node-positive esophageal cancer.
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 |
|---|---|---|---|
| Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- LV5FU2
- description
- leucovorin 200 mg/m2 and 5-fluorouracil 400 mg/m2 intravenously on day 1, followed by a 46-h protracted infusion of 5-fluorouracil 2,400 mg/m2
- interventionNames
- Drug: oxaliplatin
- type
- EXPERIMENTAL
- label
- FOLFOX
- description
- leucovorin 200 mg/m2 and 5-fluorouracil 400 mg/m2 intravenously on day 1, followed by a 46-h protracted infusion of 5-fluorouracil 2,400 mg/m2 oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h
- interventionNames
- Drug: oxaliplatin
Primary outcomes (1)
- measure
- disease-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 20 years or older * Histologically confirmed squamous cell carcinoma of esophagus * Curatively (R0) resected, lymph node positive * ECOG performance status of 0 or 1 * Restoration of oral intake \>1500 kcal/d * No prior chemotherapy except for neoadjuvant ones * No prior radiotherapy within 1 month before registration * Adequate marrow, hepatic, renal and cardiac functions * Provision of a signed written informed consent Exclusion Criteria: * Severe co-morbid illness and/or active infections * Prior treatment with oxaliplatin * Pregnant or lactating women * Active CNS metastases not controllable with radiotherapy or corticosteroids * Known history of hypersensitivity to study drugs
References
Publications (0)
Data not yet available