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Status unknownNCT01034683Updated Jan 5, 2010

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

A Phase 3 interventional study of lobaplatin , 5-FU ,leucovorin in Esophageal Carcinoma, sponsored by Taian Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-01-05.

Sponsored by Taian Cancer Hospital · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Esophageal Carcinoma
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In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's planned enrollment of 120 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Taian Cancer Hospital is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Esophageal Carcinoma

    Drug: lobaplatin , 5-FU ,leucovorin

Interventions

  • Druglobaplatin , 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.

    Also known as: LBP ,5-FU,LV

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What researchers measure

Primary outcomes

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

    Time frame: 12/31/2010

Secondary outcomes

  1. 1-year survival rate KPS score

    Time frame: 12/31/2009

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Study locations

1 site
  • Taian Cancer Hospital
    Taian, Shandong 271000, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01034683
Lead sponsor
Taian Cancer Hospital
First posted
Dec 17, 2009
Start date
Dec 2009
Primary completion
Dec 2010 (estimated)
Completion
Dec 2010 (estimated)
Last update
Jan 5, 2010

Study contacts

Lin Guan
study chair · Taian Cancer Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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