Concurrent Chemoradiotherapy Containing Paclitaxel&Cisplatin With/Without Tarceva in Locally Advanced Esophageal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Concurrent Chemoradiotherapy Containing Paclitaxel and Cisplatin With/Without Tarceva in Locally Advanced Esophageal Carcinoma: a Randomized Phase III Multi-center Trial.

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: Cisplatin
* Drug: Tarceva
* Radiation: Radiotherapy
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Enlarged field + Paclitaxel + Cisplatin + Tarceva | Drug: Paclitaxel<br>* 135mg/m2, day 1 and day 29 of the radiotherapy.<br>Drug: Cisplatin<br>* 20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.<br>Drug: Tarceva<br>* 150mg/day,oral administration, from day 1 to day 42 (at the beginning of therapy)<br>* Other names: Erlotinib Hydrochloride Tablets;Radiation: Radiotherapy<br>* Enlarged field radiotherapy<br>|
| Experimental: B<br>Enlarged field + Paclitaxel + Cisplatin | Drug: Paclitaxel<br>* 135mg/m2, day 1 and day 29 of the radiotherapy.<br>Drug: Cisplatin<br>* 20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.<br>Radiation: Radiotherapy<br>* Enlarged field radiotherapy<br>|
| Active Comparator: C<br>Conventional field + Paclitaxel + Cisplatin + Tarceva | Drug: Paclitaxel<br>* 135mg/m2, day 1 and day 29 of the radiotherapy.<br>Drug: Cisplatin<br>* 20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.<br>Drug: Tarceva<br>* 150mg/day,oral administration, from day 1 to day 42 (at the beginning of therapy)<br>* Other names: Erlotinib Hydrochloride Tablets;Radiation: Radiotherapy<br>* Conventional field radiotherapy<br>|
| Active Comparator: D<br>Conventional field + Paclitaxel + Cisplatin | Drug: Paclitaxel<br>* 135mg/m2, day 1 and day 29 of the radiotherapy.<br>Drug: Cisplatin<br>* 20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.<br>Radiation: Radiotherapy<br>* Conventional field radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | failure: death from any cause | five years after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Failure: occurrence of local or regional progression, distant metastases, or death from any cause | five years after enrollment | 
| local-regional control rate | Failure: occurrence of local or regional progression | three years after enrollment | 
| Adverse events | assessed by RTOG Acute Radiation Morbidity Scoring Criteria and RTOG/EORTC Late Radiation Morbidity Scoring Schema | five years after enrollment | 
| Health-related quality of life | assessed by the Functional Assessment of Cancer Therapy-Esophageal (FACT-E) | five years after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal cancer, chemoradiation, radiosensitivity, EGFR inhibition