A Multicenter Randomized Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
18 Years
80 Years
Both
Inoperable Esophageal Cancer Stage I-III
Trial Information
A Multicenter Randomized Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-Free-Survival
Outcome Description:
Progression-free survival (PFS) is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse.
Outcome Time Frame:
up to 2 years
Safety Issue:
Yes
Principal Investigator
Xiaodong Jiang, Doctor
Investigator Role:
Study Chair
Investigator Affiliation:
The First People`s Hospital of Lianyungang
Authority:
China: Food and Drug Administration
Study ID:
1stPeopleLianyungang
NCT ID:
NCT01732380
Start Date:
July 2012
Completion Date:
July 2013
Related Keywords:
- Inoperable Esophageal Cancer Stage I-III
- Esophageal Diseases
- Esophageal Neoplasms
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