Study of Lobaplatin，5-Fluorouracil and Leucovorin for the Treatment of Esophageal Carcinoma

NCT01034683 | Unknown Phase 3

• 1 other identifier: TACH2009001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Carcinoma

Outcome Measures

Primary Outcomes (1)

• objective response rate(ORR) time to progression (TTP) toxicities

  12/31/2010

Secondary Outcomes (1)

• 1-year survival rate KPS score

  12/31/2009

Study Arms (1)

Esophageal Carcinoma

EXPERIMENTAL

Drug: lobaplatin , 5-FU ,leucovorin

Interventions

lobaplatin , 5-FU ,leucovorin DRUG

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.

Also known as: LBP ,5-FU,LV

Esophageal Carcinoma

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taian Cancer Hospital: lead

Study Sites (1)

Taian Cancer Hospital

Taian, Shandong, 271000, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

lobaplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Lin Guan

  Taian Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 17, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 5, 2010

Record last verified: 2009-12

Locations

CN (1)