Study of Lobaplatin，5-Fluorouracil and Leucovorin for the Treatment of Esophageal Carcinoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Taian Cancer Hospital.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Taian Cancer Hospital
Information provided by:
Taian Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01034683
First received: December 16, 2009
Last updated: January 4, 2010
Last verified: December 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Carcinoma |
Drug: lobaplatin , 5-FU ,leucovorin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Esophageal Cancer
Drug Information available for:
Fluorouracil
U.S. FDA Resources
Further study details as provided by Taian Cancer Hospital:
Primary Outcome Measures:
- objective response rate(ORR) time to progression (TTP) toxicities [ Time Frame: 12/31/2010 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 1-year survival rate KPS score [ Time Frame: 12/31/2009 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034683
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034683
Locations
| China, Shandong | |
| Taian Cancer Hospital | |
| Taian, Shandong, China, 271000 | |
Sponsors and Collaborators
Taian Cancer Hospital
Investigators
| Study Chair: | Lin Guan | Taian Cancer Hospital |
More Information
No publications provided
| Responsible Party: | Taian Cancer Hospital |
| ClinicalTrials.gov Identifier: | NCT01034683 History of Changes |
| Other Study ID Numbers: | TACH2009001 |
| Study First Received: | December 16, 2009 |
| Last Updated: | January 4, 2010 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Esophageal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Gastrointestinal Diseases |
Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on February 27, 2015