Clinical trial NCT03904563: Bevacizumab After Chemoradiotherapy For Locally Advanced Lung Adenocarcinoma
Official title: A Single-armed Phase Ⅱ Study of Bevacizumab Maintenance Therapy After Chemoradiotherapy for Locally Advanced Lung Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Adenocarcinoma
Keywords: bevacizumab
Split-course Chemoradiotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: 3-year
measure: rate of grade≥2 radiation pneumonia(NCI-CTC4.0)
timeFrame: 1 year from the end of chemoradiotherapy
Secondary outcomes:
measure: overall survival
timeFrame: 3-year
measure: response rate
timeFrame: 3-year
measure: rate of grade 3-4 radiation esophagitis
timeFrame: 3-year
measure: rate of grade 3-4 radiation pneumonitis
timeFrame: 3-year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Hui Liu, Professor
role: PRINCIPAL_INVESTIGATOR
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