NCT03904563

Bevacizumab After Chemoradiotherapy For Locally Advanced Lung Adenocarcinoma

A Single-armed Phase Ⅱ Study of Bevacizumab Maintenance Therapy After Chemoradiotherapy for Locally Advanced Lung Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This prospective phase II study is to determine the efficacy and safety of bevacizumab maintenance therapy after concurrent chemoradiotherapy in locally advanced lung adenocarcinoma

Detailed description

This prospective phase II study is to determine the efficacy and safety of bevacizumab maintenance therapy after concurrent chemoradiotherapy in locally advanced lung adenocarcinoma. All patients received 4 cycles of weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡)(DP), each of 1 day's duration, combined with split-course thoracic radiotherapy, with one-month break.Bevacizumab maintenance therapy starts 1-2 months later after the chemotherapy.The recommended dose for intravenous infusion is 15mg/kg body weight, and the drug is given every 3 weeks for up to 1 year. Toxicities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0.

Conditions

• Lung Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Bevacizumab	Patients are treated with Bevacizumab 1-2 months after the chemoradiotherapy.The recommended dose for intravenous infusion is 15mg/kg body weight, which is given every 3 weeks for up to 1 year.
RADIATION	chest radiation	split-course chest radiation
DRUG	concurrent chemotherapy	weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-12-10
• Completion: 2022-12-15
• First posted: 2019-04-05
• Last updated: 2023-03-06

Locations

1 site across 1 country: China