Esophageal Squamous Cell Carcinoma
Conditions
Brief summary
The purpose of this study is to determine which regimen is better for esophageal squamous carcinoma in concurrent chemoradiation(CCRT),paclitaxel or S1 plus cisplatin.
Detailed description
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator. Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PT regimen (cisplatin of 20 mg/m2/d, d1-3; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles or PS regimen (cisplatin of 20 mg/m2/d, d1-3; S1(Tegafur Gimeracil Oteracil Potassium Capsule)of 50mg/m2/d, d1-14) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.
Interventions
OTHERPaclitaxel plus Cisplatin with radiotherapy
we want to compare which regime is better with radiotherapy, PT regime (paclitaxel and cisplatine ) Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PT regimen (cisplatin of 20 mg/m2/d, d1-3; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation. Radiotherapy:Patients will be conducted CT simulation, and Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
OTHERS1 plus Cisplatin with radiotherapy
we want to compare which regime is better with radiotherapy,SP regime (Tegafur Gimeracil Oteracil Potassium Capsule and cisplatine). Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PS regimen (cisplatin of 20 mg/m2/d, d1-3; S1(Tegafur Gimeracil Oteracil Potassium Capsule)of 50mg/m2/d, d1-14) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation. Radiotherapy:Patients will be conducted CT simulation, and Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Sponsors
Mianyang Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Pathologically proven squamous cell carcinoma of esophagus . 2. Locally advanced esophageal cancer , with no operation indication 3. M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer 4. Subjects haven't been given neither radiotherapy nor chemotherapy before 5. Age of 18-70 6. PS ≦2 7. Hemogram : WBC≧ 4000/mm3 or ANC ≧ 2000 /mm3 and Platelet ≧ 100,000/mm3 . Biochemistry : GOT/GPT ≦ 3.5 times , Cr ≦ 1.5 mg/dl and Bilirubin ≦ 2.0 mg/dl 8. With no difficulty in eating 9. Expected lifetime ≧3 months
Exclusion criteria
1. Invasion to surrounding organ ( T4 disease ) . 2. Distant metastasis , except M1a disease . 3. Complete obstruction of the esophagus, or patients who have the potential to develop perforation 4. Women in status of pregnancy 5. Patients who have complications exist as following: * Uncontrolled angina and heart failure, have a history of hospitalization in 3 months * A history of myocardial infarction in the past 6 months * There is a need for antibiotic treatment of acute bacterial or fungal infection * Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization * Drug addiction, alcoholism and AIDS disease or long-term virus carriers * Uncontrollable seizures, or loss of insight because of mental illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | five years after enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | five years after enrollment |
Contacts
Primary ContactFeng Gao, Doctor
Backup ContactBo X Du, Doctor
Outcome results
None listed