To hear about similar clinical trials, please enter your email below

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

NCT ID: NCT01732380

Condition: Inoperable Esophageal Cancer Stage I-III

Conditions: Official terms:
Esophageal Neoplasms
Oxaliplatin
Raltitrexed

Study type: Interventional

Study phase: Phase 2

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Raltitrexed
Arm group label: Raltitrexed/Oxaliplatin Plus Radiotherapy

Other name: TOMUDEX

Other name: Sai Wei Jian

Intervention type: Drug
Intervention name: Oxaliplatin
Arm group label: Raltitrexed/Oxaliplatin Plus Radiotherapy

Other name: Eloxatin

Intervention type: Radiation
Intervention name: Radiotherapy
Arm group label: Radiotherapy
Arm group label: Raltitrexed/Oxaliplatin Plus Radiotherapy

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:
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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: The First People's Hospital of Lianyungang

Address:
City: Lianyungang
Zip: 222002
Country: China

Status: Recruiting

Contact:
Last name: Xiaodong Jiang, Doctor
Email: jxdysy1970@163.com

Start date: July 2012

Completion date: July 2013

Lead sponsor:
Agency: The First People's Hospital of Lianyungang
Agency class: Other

Collaborator:
Agency: The East Hospital of Lianyungang
Agency class: Other

Collaborator:
Agency: Donghai People's Hospital
Agency class: Other

Collaborator:
Agency: People's Hospital of Ganyu
Agency class: Other

Source: The First People's Hospital of Lianyungang

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01732380

Login to your account

Did you forget your password?