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Trial Title:
Dose Escalation by Boosting Radiation Dose Within the Primary Tumor Using 18FDG-PET/CT for Unresectable Thoracic Esophageal Cancer
NCT ID:
NCT01843049
Condition:
Esophageal Cancer
Conditions: Official terms:
Esophageal Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
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.
Arm group label:
radiotherapy+chemotherapy
Intervention type:
Drug
Intervention name:
Chemotherapy (5-FU+DDP)
Description:
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.
Arm group label:
radiotherapy+chemotherapy
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Start date:
January 2013
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01843049
