A Multicenter Randomized Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Radiotherapy
- Conditions
- Inoperable Esophageal Cancer Stage I-III
- Sponsor
- The First People's Hospital of Lianyungang
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Progression-Free-Survival
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
Eligibility 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
Arms & Interventions
Radiotherapy
Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
Intervention: Radiotherapy
Raltitrexed/Oxaliplatin Plus Radiotherapy
Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
Intervention: Raltitrexed
Raltitrexed/Oxaliplatin Plus Radiotherapy
Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
Intervention: Oxaliplatin
Raltitrexed/Oxaliplatin Plus Radiotherapy
Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
Intervention: Radiotherapy
Outcomes
Primary Outcomes
Progression-Free-Survival
Time Frame: up to 2 years
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.
Secondary Outcomes
- Response Rate(up to 2 years)