Recruiting PHASE3 Multiple Brain Metastases in Lung Adenocarcinoma

New treatment option for Multiple Brain Metastases in Lung Adenocarcinoma

Official title FSRT Combines With Bevacizumab for Multiple Brain Metastases in Lung Adenocarcinoma

ClinicalTrials.gov ID: NCT07058428

What this study is testing

What is Bevacizumab?

Bevacizumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for multiple brain metastases in lung adenocarcinoma.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
For non-small cell lung cancer brain metastases, stereotactic radiotherapy is gradually replacing whole brain radiotherapy as the standard treatment. When patients have multiple brain metastases or larger tumors (diameter\>2cm), single session stereotactic radiotherapy (SRS) may cause significant neurological damage, so fractionated stereotactic radiotherapy (FSRT) is often used.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Age ≥ 18 years old;
  • Cellular or histopathological confirmation of lung adenocarcinoma;
  • Prior to enrollment, brain enhanced magnetic resonance imaging shows (1) 1-2 brain metastases, with at least one measuring ≥3 cm in diameter; or (2)...
  • At the time of enrollment, the extracranial disease status is stable;
  • Eastern Cooperative Oncology Group (ECOG) physical fitness status score 0-2 points

You likely can't join if

  • There are contraindications for bevacizumab, such as a history of cardiac and/or thromboembolic events, or uncontrolled hypertension;
  • Meningeal metastasis or extensive intracranial metastasis are not suitable for FSRT;
  • Bleeding tendency or coagulation dysfunction;
  • Patients with hemoptysis (≥ 1/2 teaspoon of fresh blood per day) within the past month;
  • Use full dose anticoagulant therapy within the past month;
  • Has experienced severe vascular disease in the past 6 months;
See the full eligibility criteria
Who can join
  • Age ≥ 18 years old;
  • Cellular or histopathological confirmation of lung adenocarcinoma;
  • Prior to enrollment, brain enhanced magnetic resonance imaging shows (1) 1-2 brain metastases, with at least one measuring ≥3 cm in diameter; or (2) 3-10 brain metastases, with at least one measuring ≥2 cm in diameter...
  • At the time of enrollment, the extracranial disease status is stable;
  • Eastern Cooperative Oncology Group (ECOG) physical fitness status score 0-2 points
  • Normal liver, kidney, and bone marrow function within 14 days prior to enrollment: peripheral blood white blood cell count ≥ 4 × 10\^9/L; neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥ 100 × 10\^9/L, hemoglobin ≥...
  • The patient and their family agree and sign an informed consent form.
What rules you out
  • There are contraindications for bevacizumab, such as a history of cardiac and/or thromboembolic events, or uncontrolled hypertension;
  • Meningeal metastasis or extensive intracranial metastasis are not suitable for FSRT;
  • Bleeding tendency or coagulation dysfunction;
  • Patients with hemoptysis (≥ 1/2 teaspoon of fresh blood per day) within the past month;
  • Use full dose anticoagulant therapy within the past month;
  • Has experienced severe vascular disease in the past 6 months;
  • Have experienced gastrointestinal fistula, perforation, or abdominal abscess within the past 6 months;
  • Has experienced hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York Class II or above), acute myocardial infarction, cerebral infarction, cerebral parenchymal hemorrhage, or other...
  • Patients with a history of arterial aneurysm or arteriovenous malformation;
  • Having undergone major surgery within 28 days, or minor surgery or needle biopsy within 48 hours;
  • Urinary protein 3-4+, or 24-hour urinary protein quantification\>1g;
  • Simultaneously accompanied by serious and uncontrolled other diseases.

The study team makes the final eligibility decision.

Where it's taking place

  • Guangzhou, Guangdong, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.