Status:
UNKNOWN
Dose Escalation by Boosting Radiation Dose Within the Primary Tumor Using 18FDG-PET/CT for Unresectable Thoracic Esophageal Cancer
Lead Sponsor:
Fudan University
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- Histopathologically proven diagnosis of esophageal squamous cell carcinoma.
- ECOG performance status 0-1.
- Able to swallow semifluid diet.
- Patients must not have received either radiotherapy or chemotherapy.
- Technically unresectable, medically inoperable, or surgery declined by the patient.
- SUVmax in the pre-treatment FDG-PET scan \> 5 for the primary tumor and the length of the primary tumor ≤10cm.
- Normal liver and renal function and adequate bone marrow reservation.
- 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.
- Written, signed informed consent.
Exclusion
- Other malignancy histology.
- Any evidence of visceral metastases.
- Prior radiotherapy to the thorax or systemic therapy for esophageal cancer.
- Evidence of deep esophageal ulcer or esophageal perforation.
- Weight loss ≥10% within half year or cachexia.
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
- 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.
- Concurrent uncontrolled medical conditions.
- Pregnant or lactating women.
- Drug addiction, alcoholism or AIDS.
- Uncontrolled seizures or psychiatric, behavioural disorders.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01843049
Start Date
January 1 2013
Last Update
April 30 2013
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China