Overview

This trial is active, not recruiting.

Condition esophageal carcinoma
Treatment lobaplatin , 5-fu ,leucovorin
Phase phase 3
Sponsor Taian Cancer Hospital
Start date December 2009
End date December 2010
Trial size 120 participants
Trial identifier NCT01034683, TACH2009001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
lobaplatin , 5-fu ,leucovorin LBP ,5-FU,LV
Participants received 2-hour lobaplatin (30 mg/m2 on day 1) and a 2-hour infusion of leucovorin (LV; 200 mg/m2 on days 1-5) followed by a 4-hour infusion of 5-FU (650 mg/m2 on days 1-5). Treatment was repeated every 21 days.

Primary Outcomes

Measure
objective response rate(ORR) time to progression (TTP) toxicities
time frame: 12/31/2010

Secondary Outcomes

Measure
1-year survival rate KPS score
time frame: 12/31/2009

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Phase 3 Study of Lobaplatin,5-Fluorouracil and Leucovorin for the Treatment of Recurrent or Metastatic Esophageal Carcinoma
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2010.
Information provided to ClinicalTrials.gov by Taian Cancer Hospital.