Esophageal Squamous Cell Carcinoma
Conditions
Keywords
esophageal cancer, Chemoradiotherapy, Simultaneous Integrated Boost Intensity
Brief summary
This study was designed to predict the toxicity and efficacy of Simultaneous Integrated Boost Intensity-modulated Chemoradiotherapy in Upper Thoracic I-IVA Esophageal Squamous Cell Carcinoma.
Interventions
RADIATIONSimultaneous integrated boost intensity-modulated chemoradiotherapy
Using IMRT technology, two fields are irradiated synchronously, prescription radiation dose: 50.4 Gy/28F in PTV-C, 1.8 Gy per fraction; 63 Gy/28F in PTV-G, 2.25 Gy per fraction. Six times of concurrent DP week regimen chemotherapy: cisplatin 20mg/m2 qw plus docetaxel 20mg/m2 qw.
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Using IMRT technology, two fields are irradiated synchronously, prescription radiation dose: 50.4 Gy/28F in PTV-C, 1.8 Gy per fraction; 63 Gy/28F in PTV-G, 2.25 Gy per fraction. Six times of concurrent DP week regimen chemotherapy: cisplatin 20mg/m2 qw plus docetaxel 20mg/m2 qw.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histological or cytologic diagnosis of esophageal squamous carcinoma; 2. Aged 18-75 years; 3. KPS ≥ 70; 4. Upper thoracic esophageal squamous carcinoma: the upper margin of the lesion is located between the entrance of esophagus and the inferior edge of the azygos vein; 5. Stage I-IVA(AJCC 6th,2009); 6. Not able to be surgically resection or rejected; 7. Not have received any prior anticancer therapy; 8. No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥4x109/L, Neutrophils (ANC )≥1.5x10\^9/L, platelet count ≥100x 10\^9/L, serum creatinine\<1.5 mg/dL,urea nitrogen \<8 mmol/L; 9. No history of malignancy; 10. No perforation of esophagus, no deep ulcer of esophagus; 11. Joined the study voluntarily and signed informed consent form.
Exclusion criteria
1. Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives; 2. Patient who has metastasis such as lung, liver metastasis; 3. Other malignant tumors; 4. Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior; 5. Uncontrollable heart disease, diabetes and hypertension, pulmonary fibrosis, and chest confirmed active pulmonary inflammation require antibiotic treatment, as well as superior vena cava compression syndrome; 6. After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy; 7. Combination of pure red cell anemia or gamma globulin; 8. Allergic to any medication component studied.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity Effect | 8 Weeks | Toxicity effect defined as over CTCAE 4 grade 3 acute radiation toxicity of esophagitis 2 weeks after completion of 6 weeks of radiation therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | One month | Time of disease progression or unrecorded time of death due to any cause from the day of admission to the first imaging confirmation |
| OS | One month | Time from admission to death |
Countries
China
Contacts
Primary ContactXi Yang, Phd
Outcome results
None listed