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

• Status: Unknown status
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus radiotherapy in subjects with inoperable esophageal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First People's Hospital of Lianyungang
• Collaborators: Donghai People's Hospital; People's Hospital of Ganyu; The East Hospital of Lianyungang
• Treatments: Oxaliplatin; Raltitrexed

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