NCT03598517

High Dose Radiation Therapy With Concurrent Chemotherapy in Locally Advanced Non-small Cell Lung Cancer

Intensity-modulated Hyperfractionated Radiotherapy Boost to Residual Metabolic Disease Following Standard Chemoradiotherapy for Locally Advanced Non-small Cell Lung 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 locoregionally advanced non-small lung cancer.

Detailed description

Local failure remains high in patients with locoregionally advanced non-small lung cancer. Given that a biological equivalent dose (BED)more than 100 Gy yields approximately a local control rate of 90% in early-stage non-small lung cancer, this BED or ever higher is logically required to control local disease for locally advanced non-small lung cancer. However, dose escalation is limited by radiation-related toxicity. Use of hyperfractionated radiation Therapy boost to residual metabolic disease as defined by positron emission tomography and computed tomography (PET/CT) immediately after standard chemoradiotherapy (SCRT) using image-guided (IG) IMRT could potentially improve local control and perhaps survival

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	high dose chemoradiotherapy	Radiation therapy: 60 Gy at 2 Gy/Fx/d over 6 weeks, immediately followed by 28.8 Gy in 24 fractions of 1.2 Gy, twice per day,on weeks 6-8 to a total dose of 88.8 Gy. concurrent chemotherapy: weekly carboplatin area under the curve (AUC) 2 and paclitaxel 45 mg/m2 over the duration (8 weeks) of radiation therapy. Adjuvant chemotherapy is planned 6 weeks after high dose chemoradiation.

Timeline

• Start date: 2018-07-01
• Primary completion: 2021-05-01
• Completion: 2022-07-01
• First posted: 2018-07-26
• Last updated: 2020-08-25

Locations

1 site across 1 country: China