NCT03905317

Bevacizumab and Radiotherapy for Oligometastasis of Lung Adenocarcinoma With Negative Driver Gene

A Single-Armed Phase II Study of Radiation and Bevacizumab Maintenance Therapy for Oligometastasis of Lung Adenocarcinoma With Negative Driver Gene

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• 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 determined to explore the efficacy and safety of radiotherapy and bevacizumab maintenance therapy for oligometastatic lung adenocarcinoma with negative driver genes

Detailed description

This prospective phase II study is determined to explore the efficacy and safety of radiotherapy and bevacizumab maintenance therapy for oligometastatic lung adenocarcinoma with negative driver genes. The patients receive SBRT radiotherapy for the primary (if any) and metastatic lesions or divided radiotherapy with or without concurrent chemotherapy.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 until disease progression or intolerable toxicity occurs. 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 Injection	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 until disease progression or intolerable toxicity occurs.
RADIATION	chest radiation	The patients receive SBRT radiotherapy for the primary (if any) and metastatic lesions or divided radiotherapy with or without concurrent chemotherapy.
DRUG	concurrent chemotherapy	weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation

Timeline

• Start date: 2019-03-01
• Primary completion: 2022-02-01
• Completion: 2022-02-01
• First posted: 2019-04-05
• Last updated: 2019-04-05

Locations

1 site across 1 country: China