- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01034683
Study of Lobaplatin,5-Fluorouracil and Leucovorin for the Treatment of Esophageal Carcinoma
January 4, 2010 updated by: Taian Cancer Hospital
Phase 3 Study of Lobaplatin,5-Fluorouracil and Leucovorin for the Treatment of Recurrent or Metastatic Esophageal Carcinoma
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shandong
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Taian, Shandong, China, 271000
- Taian Cancer Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Esophageal Carcinoma
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
objective response rate(ORR) time to progression (TTP) toxicities
Time Frame: 12/31/2010
|
12/31/2010
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1-year survival rate KPS score
Time Frame: 12/31/2009
|
12/31/2009
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Lin Guan, Taian Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Anticipated)
December 1, 2010
Study Completion (Anticipated)
December 1, 2010
Study Registration Dates
First Submitted
December 16, 2009
First Submitted That Met QC Criteria
December 16, 2009
First Posted (Estimate)
December 17, 2009
Study Record Updates
Last Update Posted (Estimate)
January 5, 2010
Last Update Submitted That Met QC Criteria
January 4, 2010
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Carcinoma
- Esophageal Neoplasms
- Physiological Effects of Drugs
- Protective Agents
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Leucovorin
Other Study ID Numbers
- TACH2009001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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