NCT03331575

Hypofractionated vs. Conventionally Fractionated Concurrent CRT for Unresectable Stage III NSCLC

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This protocol is a phase III randomized controlled trial (RCT) evaluating the efficacy of hypofractionated vs. conventionally fractionated concurrent chemo-radiotherapy for unresectable stage III non-small-cell lung cancer

Detailed description

Hypofractionated radiotherapy (RT) delivers higher doses of RT over a shorter period of time and may kill more tumor cells and may have fewer side effects. Dose escalation in unresectable stage III NSCLC has been safely achieved up to LEVEL 3 (PTV-G60.5Gy/22Fx, 2.75Gy/Fx; PTV-C 49.5Gy/22Fx, 2.25Gy/Fx). Acute toxicities were well tolerable. Further stage II clinical study has found that hypofractionated RT can significantly improve the efficacy of patients with a low toxicity profile. The aim of this study is to compared with hypofractionated and conventionally fractionated concurrent chemotherapy , and evaluate whether hypofractionated RT can improve local control and overall survival in unresectable stage III non-small-cell lung cancer (NSCLC).

Conditions

• Unresectable Stage III Non-small-cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	Arm1 (Hypofractionated radiotherapy)	hypofractionated RT（PTV-G60.5Gy/22Fx, 2.75Gy/Fx; PTV-C 49.5Gy/22Fx, 2.25Gy/Fx）, with concurrent chemotherapy : Cisplatin(20 mg/m2 d1) Docetaxel (20 mg/m2 d1),weekly, 6 cycles )

Timeline

• Start date: 2017-11-01
• Primary completion: 2020-11-01
• Completion: 2020-11-01
• First posted: 2017-11-06
• Last updated: 2017-11-06

Locations

1 site across 1 country: China