Trial | NCT01732380  Report issue

Title

A Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
A Multicenter Randomized Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    108
The aim of this study was to compare 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.
Study Started
Jul 31
2012
Primary Completion
Jul 31
2013
Anticipated
Study Completion
Jul 31
2013
Anticipated
Last Update
Nov 22
2012
Estimate

Drug Raltitrexed

  • Other names: TOMUDEX, Sai Wei Jian

Drug Oxaliplatin

  • Other names: Eloxatin

Radiation Radiotherapy

Radiotherapy Active Comparator

Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer

Raltitrexed/Oxaliplatin Plus Radiotherapy Experimental

Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer

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
No Results Posted