Recruiting PHASE2 Non-small Cell Lung Cancer

New treatment option for Non-small Cell Lung Cancer

Official title Carbon Ion Radiotherapy for Locally Advanced Lung Cancer in Elderly Patients

ClinicalTrials.gov ID: NCT06311981

What this study is testing

What it's testing
To observe the effect and toxicity of carbon ion radiotherapy on local advanced non-small cell lung cancer over 75 years old patients. Systemic therapy could be targeted therapy, chemotherapy or immunotherapy.
  • Phase 2: a mid-size study of how well it works

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

Who can take part

Ages 75 and older

You may be able to join if

  • Older than 75 years old.
  • ECOG general status score of 0-2.
  • Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological pathology, T1-4N1-3M0, stage IIb-IIIc (AJCC/UICC 8th edition).
  • Medically inoperable, or patient refuses surgery.
  • Adequate organ function: 1). Blood function: absolute neutrophil count (ANC) ≥1.5 x 109/L, platelet count ≥80 x 109/L, hemoglobin ≥9 g/dL 2). Lung...

You likely can't join if

  • Patient with squamous cell carcinoma was treated with bevacizumab before carbon ion radiotherapy.
  • Complicated with other malignant tumors that have not been controlled.
  • Patient whose particle radiotherapy plan cannot meet the minimum target dose coverage and dose volume limitation requirements, or cannot meet the...
  • Chest radiation therapy or radioactive particle implantation history.
  • Cardiac pacemakers or other internal metal prosthesis implants that may be affected by high-energy radiation or may affect the dose distribution to...
  • HIV positive. Hepatitis virus replication phase, need to receive antiviral therapy, but because of concomitant disease cannot receive antiviral...
See the full eligibility criteria
Who can join
  • Older than 75 years old.
  • ECOG general status score of 0-2.
  • Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological pathology, T1-4N1-3M0, stage IIb-IIIc (AJCC/UICC 8th edition).
  • Medically inoperable, or patient refuses surgery.
  • Adequate organ function: 1). Blood function: absolute neutrophil count (ANC) ≥1.5 x 109/L, platelet count ≥80 x 109/L, hemoglobin ≥9 g/dL 2). Lung function: FEV1\>25%, DLCO\>25% 3). Cardiac function: no serious...
  • Sign informed consent.
What rules you out
  • Patient with squamous cell carcinoma was treated with bevacizumab before carbon ion radiotherapy.
  • Complicated with other malignant tumors that have not been controlled.
  • Patient whose particle radiotherapy plan cannot meet the minimum target dose coverage and dose volume limitation requirements, or cannot meet the dose constrains of normal tissue or organs.
  • Chest radiation therapy or radioactive particle implantation history.
  • Cardiac pacemakers or other internal metal prosthesis implants that may be affected by high-energy radiation or may affect the dose distribution to the radiation target area.
  • HIV positive. Hepatitis virus replication phase, need to receive antiviral therapy, but because of concomitant disease cannot receive antiviral therapy. Active stage of syphilis.
  • A history of mental illness may hinder the completion of treatment.
  • With serious comorbidity that may interfere with radiotherapy, including: (a) Acute infectious diseases or acute active phase of chronic infection. b) Unstable angina pectoris, congestive heart failure, myocardial...
  • Other circumstances that the physician considers inappropriate to participate in clinical study.

The study team makes the final eligibility decision.

Where it's taking place

  • Shanghai, Shanghai Municipality, 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, 75 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Shanghai, Shanghai Municipality, 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.