Esophageal Cancer
Conditions
Brief summary
Most local failures after definitive chemoradiation for unresectable esophageal cancer occur in the gross tumor volume (GTV). And the metabolic active areas post-treatment were located in the high FDG uptake areas prior to the radiotherapy. The hypothesis is that selective dose boost to the esophageal GTV could be safely delivered using a simultaneous integrated boost (SIB) technique, and that boosting the high 18F-deoxyglucose (FDG) uptake areas of the esophageal GTV defined prior to treatment may improve local tumor control.
Interventions
RADIATIONRadiotherapy
Patients will receive from 5 to 6 weeks 5 days a week radiations. The dose of radiation will depend on the level they will be included.
DRUGChemotherapy (5-FU+DDP)
Patients will receive 2 cycles of concurrent chemotherapy (cisplatin 25mg/m2 IV daily on Days 1-3 and 29-31 plus 5-FU 500mg/m2 IV continuous infusion over 24h daily on Days 1-4 and 29-32) during radiotherapy period. Consolidation chemotherapy (cisplatin 25mg/m2 IV daily on Days 1-3 plus 5-FU 600mg/m2 IV daily on Days 1-5, cycled every 4 weeks) will be given for 2 cycles one month after the end of radiochemotherapy.
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histopathologically proven diagnosis of esophageal squamous cell carcinoma. 2. ECOG performance status 0-1. 3. Able to swallow semifluid diet. 4. Patients must not have received either radiotherapy or chemotherapy. 5. Technically unresectable, medically inoperable, or surgery declined by the patient. 6. SUVmax in the pre-treatment FDG-PET scan \> 5 for the primary tumor and the length of the primary tumor ≤10cm. 7. Normal liver and renal function and adequate bone marrow reservation. 8. Meet the requirements of the dose limitation to the critical organ: V20≤25%，Dmean≤15Gy for lung; Dmax ≤45Gy for spinal cord，Dmean ≤20Gy for liver. 9. Written, signed informed consent.
Exclusion criteria
1. Other malignancy histology. 2. Any evidence of visceral metastases. 3. Prior radiotherapy to the thorax or systemic therapy for esophageal cancer. 4. Evidence of deep esophageal ulcer or esophageal perforation. 5. Weight loss ≥10% within half year or cachexia. 6. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. 7. History of cardiac disease: congestive heart failure \> NYHA class 2, active CAD, cardiac arrythmias requiring anti-arrhythmic therapy or uncontrolled hypertension within the last 12 months. 8. Concurrent uncontrolled medical conditions. 9. Pregnant or lactating women. 10. Drug addiction, alcoholism or AIDS. 11. Uncontrolled seizures or psychiatric, behavioural disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity(DLT) | 3 months after the finish of the radiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 3 years | — |
| Progression-free survival (PFS) | 3 years | — |
| Failure patterns | 3 years | — |
| Late toxicity | 3 years | Esophageal perforation, esophageal bleeding or late radiation-induced lung or heart injury of grade 3 or above(CTCAE3.0) |
Other
| Measure | Time frame |
|---|---|
| Local recurrent rate within the >50% SUVmax region of the primary tumor | 3 years |
Countries
China
Contacts
Primary ContactWen Yu, MD, PHD
Outcome results
None listed