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New treatment option for Early-Stage Lung Cancer
Official title Prospective Phase II Clinical Study of Stereotactic Body Proton Therapy (SBPT) for Lung Cancer
ClinicalTrials.gov ID: NCT07412327
What this study is testing
- What it's testing
- This study included patients with early-stage lung cancer cT1-3N0M0, stage IA-IIB (American Joint Committee on Cancer eighth edition staging, AJCC 8th ) who were inoperable or refused surgery. They were divided into peripheral type and central type according to the tumor location and received radical Stereotactic Body Proton Therapy (SBPT) for Early-Stage Non-Small Cell Lung Cancer.
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
- .Lung cancer confirmed by histology and/or cytology; and in the absence of pathological diagnosis, patients who meet the following conditions can...
- The clinical staging based on positron emission tomography(PET)-computer tomography(CT) examination is: cT1\~3 N0M0, stage IA-IIB (AJCC eighth...
- Age: 18 years and above.
- Karnofsky(KPS) score ≥60.
- The doctor assesses that surgical treatment is not suitable or the patient refuses surgery.
You likely can't join if
- Patients with other malignant tumors.
- Poorly controlled heart failure, respiratory failure, heart function, and lung function below grade 3 (including grade 3).
- Those whose laboratory test values do not meet relevant standards before enrollment.
- Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
- Women of childbearing age who have a positive pregnancy test and women who are breastfeeding.
- Patients considered inappropriate for inclusion by other investigators.
See the full eligibility criteria
- .Lung cancer confirmed by histology and/or cytology; and in the absence of pathological diagnosis, patients who meet the following conditions can also be included: diagnosed by more than 2 imaging modalities, and the...
- The clinical staging based on positron emission tomography(PET)-computer tomography(CT) examination is: cT1\~3 N0M0, stage IA-IIB (AJCC eighth edition).
- Age: 18 years and above.
- Karnofsky(KPS) score ≥60.
- The doctor assesses that surgical treatment is not suitable or the patient refuses surgery.
- Relatively good organ function:
- Normal bone marrow function: white blood cell (WBC)≥3×109/L, Platelet ≥80×109/L, Hemoglobin(HGB)≥90g/L
- Normal liver and kidney function:
- Total bilirubin, Aspartate Aminotransferase(AST), and ALT(Alanine Aminotransferase)≤2.0×upper limit of normal values;
- Creatinine clearance ≥60ml/min or creatinine ≤1.5×upper limit of normal value
- The patient has signed an informed consent form and is willing and able to comply with planned study visits, treatment plans, laboratory tests, and other study procedures.
- Patients with other malignant tumors.
- Poorly controlled heart failure, respiratory failure, heart function, and lung function below grade 3 (including grade 3).
- Those whose laboratory test values do not meet relevant standards before enrollment.
- Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
- Women of childbearing age who have a positive pregnancy test and women who are breastfeeding.
- Patients considered inappropriate for inclusion by other investigators.
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.