Lung Adenocarcinoma
Conditions
Keywords
bevacizumab, Split-course Chemoradiotherapy
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.
Interventions
DRUGBevacizumab
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.
RADIATIONchest radiation
split-course chest radiation
DRUGconcurrent chemotherapy
weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 3-year | Progression-free survival in patients |
| rate of grade≥2 radiation pneumonia(NCI-CTC4.0) | 1 year from the end of chemoradiotherapy | 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
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 3-year | overall survival |
| response rate | 3-year | — |
| rate of grade 3-4 radiation esophagitis | 3-year | — |
| rate of grade 3-4 radiation pneumonitis | 3-year | — |
Countries
China
Outcome results
None listed