Concurrent Chemoradiotherapy Containing Paclitaxel&Cisplatin With/Without Tarceva in Locally Advanced Esophageal Cancer
- Conditions
- Esophageal Cancer
- Interventions
- Registration Number
- NCT00686114
- Lead Sponsor
- Wenzhou Medical University
- 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 approach the enlarged field radiotherapy and the intervention of Tarceva. And we approach the therapeutic effect for this method theoretically, which may give a further reasonable guidance for the clinical therapy.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 344
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description A Tarceva Enlarged field + Paclitaxel + Cisplatin + Tarceva C Tarceva Conventional field + Paclitaxel + Cisplatin + Tarceva A Radiotherapy Enlarged field + Paclitaxel + Cisplatin + Tarceva B Cisplatin Enlarged field + Paclitaxel + Cisplatin B Radiotherapy Enlarged field + Paclitaxel + Cisplatin C Cisplatin Conventional field + Paclitaxel + Cisplatin + Tarceva C Radiotherapy Conventional field + Paclitaxel + Cisplatin + Tarceva D Radiotherapy Conventional field + Paclitaxel + Cisplatin A Cisplatin Enlarged field + Paclitaxel + Cisplatin + Tarceva A Paclitaxel Enlarged field + Paclitaxel + Cisplatin + Tarceva B Paclitaxel Enlarged field + Paclitaxel + Cisplatin C Paclitaxel Conventional field + Paclitaxel + Cisplatin + Tarceva D Cisplatin Conventional field + Paclitaxel + Cisplatin D Paclitaxel Conventional field + Paclitaxel + Cisplatin
- Primary Outcome Measures
Name Time Method overall survival five years after enrollment failure: death from any cause
- Secondary Outcome Measures
Name Time Method Progression-free survival five years after enrollment Failure: occurrence of local or regional progression, distant metastases, or death from any cause
local-regional control rate three years after enrollment Failure: occurrence of local or regional progression
Adverse events five years after enrollment assessed by RTOG Acute Radiation Morbidity Scoring Criteria and RTOG/EORTC Late Radiation Morbidity Scoring Schema
Health-related quality of life five years after enrollment assessed by the Functional Assessment of Cancer Therapy-Esophageal (FACT-E)
Trial Locations
- Locations (1)
1st affliated hospital of Wen Zhou Medical college
🇨🇳Wen Zhou, Zhejiang, China