Clinical trial NCT01034683: Study of Lobaplatin，5-Fluorouracil and Leucovorin for the Treatment of Esophageal Carcinoma
Official title: Phase 3 Study of Lobaplatin，5-Fluorouracil and Leucovorin for the Treatment of Recurrent or Metastatic Esophageal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Esophageal Carcinoma
Lead sponsor: Taian Cancer Hospital
Sponsor class: OTHER
First posted: 2009-12-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: patients with metastatic or recurrent esophageal cancer have a particularly poor prognosis .The overall 5-year survival rate for patients with newly diagnosed esophageal cancer is under 10%. Metastatic esophageal carcinoma is an incurable disease and due to the lack of effective therapies to manage this disease,the median survival is only 6 to 8 months Chemotherapy which is one of the most effective treatment so far is used as part of combined modality therapy for locally advanced diseases or as a palliative treatment for metastatic diseases.Lobaplatin is the third generation of platinum.Phase Ⅱclinical trials indicate that lobaplatin is effective for esophageal cancer, ovarian cancer, breast cancer and small cell lung cancer.

Eligibility criteria: 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

Primary outcomes:
measure: objective response rate(ORR) time to progression (TTP) toxicities
timeFrame: 12/31/2010
Secondary outcomes:
measure: 1-year survival rate KPS score
timeFrame: 12/31/2009
Other outcomes:
Locations:
city: Taian
country: China
facility: Taian Cancer Hospital
state: Shandong
Study officials:
affiliation: Taian Cancer Hospital
name: Lin Guan
role: STUDY_CHAIR
References: