Esophageal Cancer
Conditions
Keywords
Esophageal cancer, chemoradiation, radiosensitivity, EGFR inhibition
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.
Interventions
DRUGPaclitaxel
135mg/m2, day 1 and day 29 of the radiotherapy.
DRUGCisplatin
20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.
DRUGTarceva
150mg/day,oral administration, from day 1 to day 42 (at the beginning of therapy)
RADIATIONRadiotherapy
Enlarged field radiotherapy
Sponsors
Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects must be confirmed Esophageal Carcinoma pathologically 2. (EUS)I～IVa, without contraindication for radical radiotherapy 3. Subjects haven't been given neither radiotherapy nor chemotherapy before 4. Age 18-70,behavioral status evaluation ECOG scores 0-2 and anticipated survival more than 6 months 5. 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 6. Subjects should sign for the informed consent 7. Subjects should perform good compliance 8. 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
1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy 2. Complete obstruction of the esophagus, or patients who have the potential to develop perforation 3. 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 4. Patients who multiple foci esophagus 5. Patients who are/were given any other medicine tests currently/in last 4 weeks 6. Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines 7. Women in status of pregnancy 8. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | five years after enrollment | failure: death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Contacts
Primary ContactShixiu Wu, MD
Outcome results
None listed