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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified December 2009 by Taian Cancer Hospital.
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by:

Taian Cancer Hospital

ClinicalTrials.gov Identifier:

NCT01034683

First received: December 16, 2009

Last updated: January 4, 2010

Last verified: December 2009

History of Changes

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

Genetic and Rare Diseases Information Center resources: Esophageal Cancer

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 ]

Secondary Outcome Measures:

1-year survival rate KPS score [ Time Frame: 12/31/2009 ]


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 (Adult)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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


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

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on June 23, 2017

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