NCT03936179

High Dose PET/CT-guided Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer

Phase II Trial of High Dose PET/CT-guided Radiation Therapy With Concurrent Weekly Carboplatin and Paclitaxel in Localregionally Advanced Esophageal Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locaregionally esophageal cancer

Detailed description

Standard dose chemoradiotherapy (SCRT) results in poor local control for localregionally advanced esopgageal cancer patients. Most local failures occur in the gross tumor volume.\[F-18\]-fluorodeoxyglucose (FDG) PET/CT can identify residual metabolic disease (RMD). Hyperfractionated radiotherapy allows for delivering a higher dose without increasing late toxicity. Our previous phase I radiation dose escalation trial demonstrated that 86 Gy could be safely delivered to the RMD with concurrent weekly paclitaxel and cisplatin in advanced esophageal cancer.The aim of this phase II study is to examine the efficacy of this regimen.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
RADIATION	high dose radiation therapy with concurrent chemotherapy	standard dose of 50 Gy concurrent weekly with paclitaxel (45 mg/m2) and carboplatin (area under curve 1.5 ), immediately followed by hyperfractionated radiotherapy boost of 36 Gy in 30 fractions of 1.2 Gy to residual metabolic disease as defined by PET/CT

Timeline

• Start date: 2018-08-01
• Primary completion: 2021-08-01
• Completion: 2022-04-01
• First posted: 2019-05-03
• Last updated: 2021-03-18

Locations

1 site across 1 country: China