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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
