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

NCT03905317 | Unknown Phase 2

• 1 other identifier: GASTO-1047
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Adenocarcinoma

Keywords

bevacizumab; chemoradiotherapy; Oligometastasis of lung adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-free survival in patients

  3-year

Secondary Outcomes (4)

• OS

  3-year

• response rate

  3-year

• rate of grade 3-4 radiation esophagitis

  3-year

• rate of grade 3-4 radiation pneumonitis

  3-year

Study Arms (1)

Bevacizumab

EXPERIMENTAL

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.

Drug: Bevacizumab Injection; Radiation: chest radiation; Drug: concurrent chemotherapy

Interventions

Bevacizumab Injection DRUG

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.

Bevacizumab

chest radiation RADIATION

The patients receive SBRT radiotherapy for the primary (if any) and metastatic lesions or divided radiotherapy with or without concurrent chemotherapy.

Bevacizumab

concurrent chemotherapy DRUG

weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation

Bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• ≥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.
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (19)

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MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hui Liu, Professor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Qiu, Attending

CONTACT

+86-020-87343031; qiubo@sysucc.org.cn

Hui liu, Professor

CONTACT

+86-020-87343031; liuhui@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: April 5, 2019
• Study Start: March 1, 2019
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: April 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)