Clinical trial · Interventional
Study of Lobaplatin,5-Fluorouracil and Leucovorin for the Treatment of Esophageal Carcinoma
Phase 3 Study of Lobaplatin,5-Fluorouracil and Leucovorin for the Treatment of Recurrent or Metastatic Esophageal Carcinoma
NCT01034683CI-TRIAL-00002959unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the efficacy and the toxicity of lobaplatin, 5-fluorouracil (5-FU) and leucovorin in patients with esophageal carcinoma.
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 Carcinoma | Esophageal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lobaplatin , 5-FU ,leucovorin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Esophageal Carcinoma
- interventionNames
- Drug: lobaplatin , 5-FU ,leucovorin
Primary outcomes (1)
- measure
- objective response rate(ORR) time to progression (TTP) toxicities
- timeFrame
- 12/31/2010
Secondary outcomes (1)
- measure
- 1-year survival rate KPS score
- timeFrame
- 12/31/2009
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven squamous cell carcinoma of the esophagus(include cardiac cancer) * Newly diagnosed patients should be unable or unwilling to surgery * Recurrence after surgery must have no adjuvant chemotherapy or radiotherapy are allowed * Patients are required to have dimensionally measurable disease,with an objective measurable focus:preferably the use of spiral computed tomography(CT)and measurements of maximum diameter≥1cm. * Cooperative Oncology Group performance status 0-2 or KPS score ≥60,survival time ≥3 months * Neutrophils(ANC)≥1.5×109/L; blood platelets counts(BPC)≥80×109/L * Hemoglobin(Hgb)≥90g/L ,serum total bilirubin ≤1.0 times the upper normal limit(ULN): alanine aminotransferase and glutamic-oxalacetic transaminase (ALT and AST)≤2.5 ULN * Serum creatinine (Cr)≤1.5ULN Exclusion Criteria: * pregnant or nursing women; * Female patients at child-bearing age, without taking effective contraceptive methods; * patients who have pathologic confirmation of other types of tumors (eg, leiomyosarcoma, malignant lymphoma) rather than esophageal cancer; * patients with tumors other than esophageal cancer ,except cervical carcinoma in situ and skin basal cancer or squamous cell carcinoma received adequate treatment; * patients with cerebral or meningeal metastasis, intestinal obstruction, or symptomatic pathologic changes of peripheral nerve,NCIC-CTG standard \>grade 2 * patients with serious complications such as: serious heart disease remained unstable after treatment, or myocardial infarction, congestive heart failure, unstable angina, frank pericardial effusion or unstable arrhythmias in 6 months before being enrolled into the group; confirmed neuropathy or psychosis, including dementia or epilepsia; uncontrolled infection;active disseminated intravascular coagulation;uncontrolled diabetes, fasting serum glucose\> 7.8mmol / L
References
Publications (0)
Data not yet available
No reference posted for this study.