Clinical trial NCT01843049: Dose Escalation by Boosting Radiation Dose Within the Primary Tumor Using 18FDG-PET/CT for Unresectable Thoracic Esophageal Cancer
Official title: Dose Escalation Using a Simultaneous Integrated Boost Technique Based on 18FDG-PET/CT for Unresectable Thoracic Esophageal Cancer: a Phase I/II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Esophageal Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Dose limiting toxicity(DLT)
timeFrame: 3 months after the finish of the radiotherapy
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 3 years
measure: Progression-free survival (PFS)
timeFrame: 3 years
measure: Failure patterns
timeFrame: 3 years
measure: Late toxicity
timeFrame: 3 years
Other outcomes:
measure: Local recurrent rate within the >50% SUVmax region of the primary tumor
timeFrame: 3 years
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Xiaolong Fu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu W, Cai XW, Liu Q, Zhu ZF, Feng W, Zhang Q, Zhang YJ, Yao ZF, Fu XL. Safety of dose escalation by simultaneous integrated boosting radiation dose within the primary tumor guided by (18)FDG-PET/CT for esophageal cancer. Radiother Oncol. 2015 Feb;114(2):195-200. doi: 10.1016/j.radonc.2014.12.007. Epub 2015 Jan 10.