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A Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
Conditions
Inoperable Esophageal Cancer Stage I-III
Conditions: official terms
Esophageal Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Raltitrexed
Type: Drug
Name: Oxaliplatin
Type: Drug
Name: Radiotherapy
Type: Radiation
Overall Status
Recruiting
Summary
The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus radiotherapy in subjects with inoperable esophageal cancer.
Detailed Description
108 patients were randomized to receive Raltitrexed/Oxaliplatin Plus Radiotherapy (Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks.)or Radiotherapy ( Radiotherapy 2.0Gy/day, 5 times/week,6 weeks) in subjects with Inoperable esophageal cancer. All patients will receive therapy of six weeks unless disease progression or unacceptable toxicity. Patients were evaluated every 3 months .Progression-Free-Survival was the primary endpoint. Response Rate, Overall survival, toxicity of the therapy are other second endpoint.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
- Confirmed diagnosis of inoperable esophageal cancer(squamous cell carcinoma)
- Measurable disease according to RECIST criteria
- Age > 18 years
- WHO performance score < 2
- Estimated life expectancy of > 12 weeks
- Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy
- Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL
- Renal function: Cr ≤ 1.25×UNL
- Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL
- Documented informed consent to participate in the trial
Exclusion Criteria:
- Subjects with distant metastases
- Pregnancy or breast feeding. Women of childbearing age must use effective contraception
- Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
- Evidence of bleeding diathesis or serious infection
- pregnant or lactating woman
- Patient participation in other studies
- Confirmed diagnosis of inoperable esophageal cancer(squamous cell carcinoma)
- Measurable disease according to RECIST criteria
- Age > 18 years
- WHO performance score < 2
- Estimated life expectancy of > 12 weeks
- Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy
- Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL
- Renal function: Cr ≤ 1.25×UNL
- Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL
- Documented informed consent to participate in the trial
Exclusion Criteria:
- Subjects with distant metastases
- Pregnancy or breast feeding. Women of childbearing age must use effective contraception
- Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
- Evidence of bleeding diathesis or serious infection
- pregnant or lactating woman
- Patient participation in other studies
Location
The First People`s Hospital of Lianyungang
Lianyungang, Jiangsu, China
Status: Recruiting
Contact: Xiaodong Jiang, Doctor - jxdysy1970@163.com
Start Date
July 2012
Completion Date
July 2013
Sponsors
The First People's Hospital of Lianyungang
Source
The First People's Hospital of Lianyungang
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page