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

Primary Purpose

Esophageal Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
lobaplatin , 5-FU ,leucovorin
Sponsored by
Taian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Carcinoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taian Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Esophageal Carcinoma

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

1-year survival rate KPS score

Full Information

First Posted
December 16, 2009
Last Updated
January 4, 2010
Sponsor
Taian Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01034683
Brief Title
Study of Lobaplatin，5-Fluorouracil and Leucovorin for the Treatment of Esophageal Carcinoma
Official Title
Phase 3 Study of Lobaplatin，5-Fluorouracil and Leucovorin for the Treatment of Recurrent or Metastatic Esophageal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Taian Cancer Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Esophageal Carcinoma
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
lobaplatin , 5-FU ,leucovorin
Other Intervention Name(s)
LBP ,5-FU,LV
Intervention Description
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.
Primary Outcome Measure Information:
Title
objective response rate(ORR) time to progression (TTP) toxicities
Time Frame
12/31/2010
Secondary Outcome Measure Information:
Title
1-year survival rate KPS score
Time Frame
12/31/2009

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Guan
Organizational Affiliation
Taian Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Taian Cancer Hospital
City
Taian
State/Province
Shandong
ZIP/Postal Code
271000
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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