Lung Adenocarcinoma
Conditions
Keywords
bevacizumab, chemoradiotherapy, Oligometastasis of lung adenocarcinoma
Brief 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.
Interventions
DRUGBevacizumab 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.
RADIATIONchest radiation
The patients receive SBRT radiotherapy for the primary (if any) and metastatic lesions or divided radiotherapy with or without concurrent chemotherapy.
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
* Pathological confirmation of lung adenocarcinoma with negative driver gene including EGFR and ALK. * Simultaneous oligometastasis, or oligometastasis which occurs after treatment of stage i-iii lung adenocarcinoma (1-5 metastases) * Oligometasis confirmed by CT, brain MR, bone ECT or PETCT within 30 days before enrollment.
Exclusion criteria
* ≥18 years old * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Organ and bone marrow functions are 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. * Negative pregnancy test 1 week before enrollment for women of childbearing age. * Patients with concurrent oligostasis should have received at least 4 courses of first-line chemotherapy, and SD or PR should be evaluated after chemotherapy; * Patients with stage i-iii lung adenocarcinoma with oligo-metastasis after treatment who have previously received systemic chemotherapy (such as concurrent radiotherapy chemotherapy or postoperative adjuvant chemotherapy) are admitted to the group; * Patients who have received brain radiation therapy due to brain metastasis are admitted to the group. * The baseline is the exsiting of measurable lesions, and the metastatic lesions are treated with local radiotherapy;The number of metastases defines as: * \- A) two metastatic lesions are identified when bilateral adrenal glands have lesions; * \- B) two consecutive vertebral lesions and paravertebral lesions within 6cm can be considered as one metastatic lesion, and the lesions of non-continuous vertebral body should be counted separately; * \- C) the adjacent lesions in the liver, lung and mediastinum can be considered as a metastatic lesion if one isocentric irradiation can be used; * For simultaneous oligostasis, the feasibility of primary focus radiotherapy should be evaluated, and the primary focus must be capable of receiving radiotherapy before being enrolled;For the primary lesion, SBRT or fractionated radiotherapy can be applied according to the site and surrounding invasion. * For the heterogeneous oligometastasis of the primary lesion that has received surgery or local radiotherapy, the feasibility of local radiotherapy should be evaluated when the local recurrence lesion occurs, and the local recurrence lesion can be treated with subdivided radiotherapy or SBRT before inclusion; * Patients with intracranial metastasis are allowed to be enrolled, but the intracranial lesions should be treated in advance and be in a stable state, and the number of intracranial lesions should be counted within the number of metastases. * Patients should be enrolled within 35 days after the last systemic treatment; * Patients and their family signed the informed consents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 3-year | Progression-free survival in patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 3-year | overall survival in patients |
| response rate | 3-year | — |
| rate of grade 3-4 radiation esophagitis | 3-year | — |
| rate of grade 3-4 radiation pneumonitis | 3-year | — |
Countries
China
Contacts
Primary ContactBo Qiu, Attending
Backup ContactHui liu, Professor
Outcome results
None listed