Study of Lobaplatin,5-Fluorouracil and Leucovorin for the Treatment of Esophageal Carcinoma
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ClinicalTrials.gov Identifier: NCT01034683 |
Recruitment Status : Unknown
Verified December 2009 by Taian Cancer Hospital.
Recruitment status was: Active, not recruiting
First Posted : December 17, 2009
Last Update Posted : January 5, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Esophageal Carcinoma | Drug: lobaplatin , 5-FU ,leucovorin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 3 Study of Lobaplatin,5-Fluorouracil and Leucovorin for the Treatment of Recurrent or Metastatic Esophageal Carcinoma |
Study Start Date : | December 2009 |
Estimated Primary Completion Date : | December 2010 |
Estimated Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Esophageal Carcinoma |
Drug: lobaplatin , 5-FU ,leucovorin
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.
Other Name: LBP ,5-FU,LV |
- objective response rate(ORR) time to progression (TTP) toxicities [ Time Frame: 12/31/2010 ]
- 1-year survival rate KPS score [ Time Frame: 12/31/2009 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034683
China, Shandong | |
Taian Cancer Hospital | |
Taian, Shandong, China, 271000 |
Study Chair: | Lin Guan | Taian Cancer Hospital |
Responsible Party: | Taian Cancer Hospital |
ClinicalTrials.gov Identifier: | NCT01034683 History of Changes |
Other Study ID Numbers: |
TACH2009001 |
First Posted: | December 17, 2009 Key Record Dates |
Last Update Posted: | January 5, 2010 |
Last Verified: | December 2009 |
Carcinoma Esophageal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms Digestive System Diseases |
Esophageal Diseases Gastrointestinal Diseases Fluorouracil Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |