Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Adenocarcinoma

Adenocarcinoma of Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Lung Adenocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Treatment with previous regimen of combined chemotherapy

Adding bevacizumab to the previous regimen of combined chemotherapy

The patients in conventional group continued the previous chemotherapy,and the patients in experimental group received adding bevacizumab to previous chemotherapy regimen.

bevacizumab

Bin Ai, Docter

Xu Li, Master

Yixin Zeng, Doctor

Previous studies have shown that the addition of bevacizumab to the standard first-line platinum-based combination therapy can improve the objective response rate of patients with advanced non-squamous non-small cell lung cancer by 20% to 28% and improve survival. Data from these published literatures suggest that the improvement in objective response rates is due mainly to patients with stable disease of chemotherapy. It has been reported that 15% of patients achieved objective remission after continuing treatment with the regimen after receiving 2 cycles of platinum-based combination chemotherapy. Therefore, the use of 2 cycles of chemotherapy after stabilization of patients with bevacizumab, hoping to improve the objective response rate of such patients 20%, and may improve survival. For the above reasons, design this study to validate our hypothesis.

Previous studies have shown that the addition of bevacizumab to the standard first-line platinum-based combination therapy can improve the objective response rate of patients with advanced non-squamous non-small cell lung cancer by 20% to 28% and improve survival. Data from these published literatures suggest that the improvement in objective response rates is due mainly to patients with stable disease of chemotherapy. It has been reported that 15% of patients achieved objective remission after continuing treatment with the regimen after receiving 2 cycles of platinum-based combination chemotherapy. Therefore, the use of 2 cycles of chemotherapy after stabilization of patients with bevacizumab, hoping to improve the objective response rate of such patients 20%, and may improve survival. For the above reasons, design this study to validate our hypothesis.

So a prospective cohort study has been designed to confirm this hypothesis, patients with advanced pulmonary adenocarcinoma who are stable after two cycles of platinum-based combination chemotherapy are objects of this study, and they can choose to continue the previous treatment regimen according to the guideline or adding bevacizumab to the regimen independently until the progression or intolerance of toxicity, or 4 to 6 cycles of chemotherapy in stable disease. The objective response rate in these two groups who received different treatment is the primary endpoint and the toxicity, quality of life, the progression free survival are the second endpoints.

Effectiveness and Safety of Adding Bevacizumab to First Line Chemotherapy in Lung Cancer Patients With Stable Disease

Effectiveness and Safety of Adding Bevacizumab to Chemotherapy in Patients With Advanced Lung Adenocarcinoma With Stable Disease After 2 Cycles of First Line Combination Chemotherapy: a Multicenter, Prospective Cohort Study

The percentage of patients who was assessed as complete response and partial response according RECIST (Response Evaluation In Solid Tumors).

The duration in responsive patients from the first remission to the progression.

The time from the day written consent to the first date of objective progression or death from any cause.

The adverse effects of the treatment especially in hematology,cardiovascular system and renal system according the CTCAE 4.0, and the SAE(serious adverse events) in the treatment and follow up.

The quality of life should be assessed in the study using FACT-L(Functional Assessment of Cancer Therapy - Lung).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effectiveness and Safety of Adding Bevacizumab to First Line Chemotherapy in Lung Cancer Patients With Stable Disease	NCT03240549	Non-small Cell ...	bevacizumab	18 Years - 75 Years	Beijing Hospital
Effectiveness and Safety of Adding Bevacizumab to First Line Chemotherapy in Lung Cancer Patients With Stable Disease	NCT03240549	Non-small Cell ...	bevacizumab	18 Years - 75 Years	Beijing Hospital

Spots Global Cancer Trial Database for advanced pulmonary adenocarcinoma