Dose Escalation by Boosting Radiation Dose Within the Primary Tumor Using 18FDG-PET/CT for Unresectable Thoracic Esophageal Cancer

Esophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01843049
• Other study ID #: 2013ESO_FU_01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 24, 2013
• Last updated: April 26, 2013
• Start date: January 2013

Study information

• Verified date: April 2013
• Source: Fudan University
• Contact: Wen Yu, MD, PHD
• Phone: 8621-64175590
• Email: yuzhiwen0827[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Radiation:
• Radiotherapy
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.

Drug:
• Chemotherapy (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.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Local recurrent rate within the >50% SUVmax region of the primary tumor		3 years	No
Primary	Dose limiting toxicity(DLT)		3 months after the finish of the radiotherapy	Yes
Secondary	Overall survival (OS)		3 years	No
Secondary	Progression-free survival (PFS)		3 years	No
Secondary	Failure patterns		3 years	No
Secondary	Late toxicity	Esophageal perforation, esophageal bleeding or late radiation-induced lung or heart injury of grade 3 or above(CTCAE3.0)	3 years	Yes