Bevacizumab After Chemoradiotherapy For Locally Advanced Lung Adenocarcinoma

NCT03904563 | Completed Phase 2

• 1 other identifier: GASTO-1046
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Adenocarcinoma

Keywords

bevacizumab; Split-course Chemoradiotherapy

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

  Progression-free survival in patients

  3-year

• 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 .

  1 year from the end of chemoradiotherapy

Secondary Outcomes (4)

• overall survival

  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

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.

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

Interventions

Bevacizumab DRUG

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.

Bevacizumab

chest radiation RADIATION

split-course chest radiation

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:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Related Publications (13)

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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

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 13, 2019
• First Posted: April 5, 2019
• Study Start: January 1, 2019
• Primary Completion: December 10, 2021
• Study Completion: December 15, 2022
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)