Status:
UNKNOWN
Concurrent Chemoradiotherapy Containing Paclitaxel&Cisplatin With/Without Tarceva in Locally Advanced Esophageal Cancer
Lead Sponsor:
Wenzhou Medical University
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This study is multi-center randomized phase III one to evaluate the difference in local-control and survival rate between patients receiving concurrent chemoradiotherapy combined Tarceva or not.
Detailed Description
For the esophageal carcinoma in II\~III stage, routine dosage of Paclitaxel and platinum medicine chemotherapy concurrently radical radiotherapy is worthy to be studied. On this base, we advanced appr...
Eligibility Criteria
Inclusion
- Subjects must be confirmed Esophageal Carcinoma pathologically
- (EUS)I～IVa, without contraindication for radical radiotherapy
- Subjects haven't been given neither radiotherapy nor chemotherapy before
- Age 18-70,behavioral status evaluation ECOG scores 0-2 and anticipated survival more than 6 months
- In 7 days after being selected, subjects should follow the status: WBC ≥ 4.0 x 10\^9/L; ANC ≥ 1.5x 10\^9/L; PLT ≥ 100 x 10\^9/L; Hb ≥ 90 g/L; serum Cr ≤ ULN; serum bilirubin ≤ 1.5 ULN; ALT/AST ≤ 1.5 ULN
- Subjects should sign for the informed consent
- Subjects should perform good compliance
- Male and female subjects who have the ability of fertility should take contraception during the whole course and also 3 months after last dosage.In 7 days before the inclusion, urine pregnancy tests of subjects should be negative.
Exclusion
- Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy
- Complete obstruction of the esophagus, or patients who have the potential to develop perforation
- Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival ≥2 years
- Patients who multiple foci esophagus
- Patients who are/were given any other medicine tests currently/in last 4 weeks
- Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines
- Women in status of pregnancy
- Patients who have complications exist as following:
- (1)Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2)A history of myocardial infarction in the past 6 months; (3)There is a need for antibiotic treatment of acute bacterial or fungal infection; (4)Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5)Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6)Uncontrollable seizures, or loss of insight because of mental illness
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT00686114
Start Date
May 1 2008
End Date
December 1 2014
Last Update
April 29 2014
Active Locations (1)
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1
1st affliated hospital of Wen Zhou Medical college
Wenzhou, Zhejiang, China, 325000