Back to resultsBevacizumab After Chemoradiotherapy For Locally Advanced Lung Adenocarcinoma
Primary Purpose
Lung Adenocarcinoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Bevacizumab
chest radiation
concurrent chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Lung Adenocarcinoma focused on measuring bevacizumab, Split-course Chemoradiotherapy
Eligibility Criteria
Inclusion Criteria:
- Pathologic confirmation of lung adenocarcinoma
- Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Unresectable, refusing surgery or after R2 surgery ,confirmed by PET-CT or chest and abdominal CT, craniocerebral MRI, and ECT.
- After radiotherapy and chemotherapy, the tumor is in partial remission, complete remission or stable.
- 1-2 months after chemoradiotherapy ends.
- Organ and bone marrow functions were normal within the first 30 days of enrollment, including: • AST, ALT≤ 2.5*ULN or ≤5*ULN (with liver metastasis); • TBil ≤ 1.5 ULN • neutrophils absolute value ≥500 cells/mm3 • creatinine clearance ≥45 mL/min ;• platelets≥50,000 cells/mm3.
- CB6 within normal limits
- Patients and their family signed the informed consents
Exclusion Criteria:
- Lung squamous carcinoma.
- The tumor has completely approached, encircled, or invaded the intravascular space of the great vessels (e.g., the pulmonary artery or the superior vena cava).
- The tumor was associated with a cavity over 2cm in diameter.
- Bleeding tendency or coagulation disorder.
- Patients with hemoptysis (1/2 teaspoon blood/day) within 1 month.
- Full-dose anticoagulation therapy was used within the past 1 month.
- Severe vascular disease occurred within 6 months.
- Gastrointestinal fistula, perforation or abdominal abscess occurred within 6 months.
- Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months.
- Uncontrolled hypertension (systolic > 150mmHg and/or diastolic > 100mmHg).
- Major surgery within 28 days or minor surgery or needle biopsy within 48 hours.
- Urine protein 3-4+, or 24h urine protein quantitative >1g.
- Degree 3 esophagitis after chemoradiotherapy has not recovered.
- Elderly patients (age 75 years).
- The investigator does not consider the participant to be eligible for this study.
Sites / Locations
- Sun yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bevacizumab
Arm Description
All patients received four 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.Then every patients are treated with Bevacizumab 1-2 months later.The recommended dose for intravenous infusion is 15mg/kg body weight, which is given every 3 weeks for up to 1 year.
Outcomes
Primary Outcome Measures
Progression-free survival
Progression-free survival in patients
rate of grade≥2 radiation pneumonia(NCI-CTC4.0)
radiation-induced pulmonary injury is classified into 1-5 grades according to NCI-CTC4.0. The incidence of symptomatic radiation-induced pulmonary injury: the ratio of grade 2 and above radiation-induced pulmonary injury cases in 1 year after radio therapy to all cases can be evaluated .
Secondary Outcome Measures
overall survival
overall survival
response rate
rate of grade 3-4 radiation esophagitis
rate of grade 3-4 radiation pneumonitis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03904563
Brief Title
Bevacizumab After Chemoradiotherapy For Locally Advanced Lung Adenocarcinoma
Official Title
A Single-armed Phase Ⅱ Study of Bevacizumab Maintenance Therapy After Chemoradiotherapy for Locally Advanced Lung Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
December 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Adenocarcinoma
Keywords
bevacizumab, Split-course Chemoradiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab
Arm Type
Experimental
Arm Description
All patients received four 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.Then every patients are treated with Bevacizumab 1-2 months later.The recommended dose for intravenous infusion is 15mg/kg body weight, which is given every 3 weeks for up to 1 year.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
chest radiation
Intervention Description
split-course chest radiation
Intervention Type
Drug
Intervention Name(s)
concurrent chemotherapy
Intervention Description
weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Progression-free survival in patients
Time Frame
3-year
Title
rate of grade≥2 radiation pneumonia(NCI-CTC4.0)
Description
radiation-induced pulmonary injury is classified into 1-5 grades according to NCI-CTC4.0. The incidence of symptomatic radiation-induced pulmonary injury: the ratio of grade 2 and above radiation-induced pulmonary injury cases in 1 year after radio therapy to all cases can be evaluated .
Time Frame
1 year from the end of chemoradiotherapy
Secondary Outcome Measure Information:
Title
overall survival
Description
overall survival
Time Frame
3-year
Title
response rate
Time Frame
3-year
Title
rate of grade 3-4 radiation esophagitis
Time Frame
3-year
Title
rate of grade 3-4 radiation pneumonitis
Time Frame
3-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathologic confirmation of lung adenocarcinoma
Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Unresectable, refusing surgery or after R2 surgery ,confirmed by PET-CT or chest and abdominal CT, craniocerebral MRI, and ECT.
After radiotherapy and chemotherapy, the tumor is in partial remission, complete remission or stable.
1-2 months after chemoradiotherapy ends.
Organ and bone marrow functions were normal within the first 30 days of enrollment, including: • AST, ALT≤ 2.5*ULN or ≤5*ULN (with liver metastasis); • TBil ≤ 1.5 ULN • neutrophils absolute value ≥500 cells/mm3 • creatinine clearance ≥45 mL/min ;• platelets≥50,000 cells/mm3.
CB6 within normal limits
Patients and their family signed the informed consents
Exclusion Criteria:
Lung squamous carcinoma.
The tumor has completely approached, encircled, or invaded the intravascular space of the great vessels (e.g., the pulmonary artery or the superior vena cava).
The tumor was associated with a cavity over 2cm in diameter.
Bleeding tendency or coagulation disorder.
Patients with hemoptysis (1/2 teaspoon blood/day) within 1 month.
Full-dose anticoagulation therapy was used within the past 1 month.
Severe vascular disease occurred within 6 months.
Gastrointestinal fistula, perforation or abdominal abscess occurred within 6 months.
Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months.
Uncontrolled hypertension (systolic > 150mmHg and/or diastolic > 100mmHg).
Major surgery within 28 days or minor surgery or needle biopsy within 48 hours.
Urine protein 3-4+, or 24h urine protein quantitative >1g.
Degree 3 esophagitis after chemoradiotherapy has not recovered.
Elderly patients (age 75 years).
The investigator does not consider the participant to be eligible for this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Liu, Professor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Bevacizumab After Chemoradiotherapy For Locally Advanced Lung Adenocarcinoma
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