Bevacizumab After Chemoradiotherapy For Locally Advanced Lung Adenocarcinoma

Sun Yat-sen University

Status and phase: Completed; Phase 2

Conditions: Lung Adenocarcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03904563

GASTO-1046

Details and patient eligibility

About

This prospective phase II study is to determine the efficacy and safety of bevacizumab maintenance therapy after concurrent chemoradiotherapy in locally advanced lung adenocarcinoma

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Bevacizumab

Experimental group

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.

Treatment:

Drug: concurrent chemotherapy

Radiation: chest radiation

Drug: Bevacizumab