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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
344
135mg/m2, day 1 and day 29 of the radiotherapy.
20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.
150mg/day,oral administration, from day 1 to day 42 (at the beginning of therapy)
1st affliated hospital of Wen Zhou Medical college
Wenzhou, Zhejiang, China
RECRUITINGoverall survival
failure: death from any cause
Time frame: five years after enrollment
Progression-free survival
Failure: occurrence of local or regional progression, distant metastases, or death from any cause
Time frame: five years after enrollment
local-regional control rate
Failure: occurrence of local or regional progression
Time frame: three years after enrollment
Adverse events
assessed by RTOG Acute Radiation Morbidity Scoring Criteria and RTOG/EORTC Late Radiation Morbidity Scoring Schema
Time frame: five years after enrollment
Health-related quality of life
assessed by the Functional Assessment of Cancer Therapy-Esophageal (FACT-E)
Time frame: five years after enrollment
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Enlarged field radiotherapy
Conventional field radiotherapy