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Phase 3 Study of Lobaplatin,5-Fluorouracil and Leucovorin for the Treatment of Recurrent or Metastatic Esophageal Carcinoma

Phase 3
18 Years
65 Years
Open (Enrolling)
Esophageal Carcinoma

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Trial Information

Phase 3 Study of Lobaplatin,5-Fluorouracil and Leucovorin for the Treatment of Recurrent or Metastatic Esophageal Carcinoma

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.

Inclusion Criteria:

- Histologically proven squamous cell carcinoma of the esophagus(include cardiac

- Newly diagnosed patients should be unable or unwilling to surgery

- Recurrence after surgery must have no adjuvant chemotherapy or radiotherapy are

- 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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:


Safety Issue:


Principal Investigator

Lin Guan

Investigator Role:

Study Chair

Investigator Affiliation:

Taian Cancer Hospital


China: Food and Drug Administration

Study ID:




Start Date:

December 2009

Completion Date:

December 2010

Related Keywords:

  • Esophageal Carcinoma
  • Carcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms