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Radiation Therapy
Pre-Transplant Radiation for Lung Cancer (NORTh STAR Trial)
N/A
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with end-stage lung disease and suspected stage I primary lung cancer based on CT and PET scan not accessible to curative treatment, including surgery and ablative SBRT.
Patients with isolated metastases in one or both lungs after complete resection of the primary tumor in the absence of other sites of metastatic disease, not accessible to curative treatment, including surgery and ablative SBRT.
Must not have
Age < 18
Mediastinal nodes metastasis demonstrated on EBUS-TBNA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to four years
Awards & highlights
No Placebo-Only Group
Summary
This trial involves giving short bursts of radiation to lung cancer tumors before a lung transplant. It targets patients with lung cancer who are getting a lung transplant. The radiation might help the body’s immune system recognize and fight the cancer, reducing the chance of it coming back after the transplant.
Who is the study for?
This trial is for adults over 18 with end-stage lung disease and suspected early-stage lung cancer, who are eligible for a lung transplant but can't have curative surgery. It's not for those with previous chest radiation, mediastinal node or distant metastasis, or other conditions that could affect participation.
What is being tested?
The study tests non-ablative oligofractionated radiation therapy (NORT) before lung transplantation to see if it's safe and can act as a 'radiovaccination', potentially reducing cancer recurrence by triggering an immune response against the tumor.
What are the potential side effects?
While specific side effects aren't listed here, NORT may cause typical radiation-related issues like skin changes at the treatment site, fatigue, inflammation of treated organs, and potential impacts on normal tissue near tumors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is in early stage but can't be treated with surgery or targeted radiation.
Select...
I had surgery to remove a lung tumor and have no other cancer spread that can be treated.
Select...
I am 18 years old or older.
Select...
I have multiple lung cancer spots that cannot be removed or cured with surgery or targeted radiation.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18 years old.
Select...
My cancer has spread to the lymph nodes in my chest, confirmed by a specific biopsy.
Select...
My cancer has spread to distant parts of my body, confirmed by a scan.
Select...
I've had chest radiation before that makes more radiation risky.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to four years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to four years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose for Radiation
Secondary study objectives
Local recurrence
Patient Morbidity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental: RadiationExperimental Treatment1 Intervention
Patients will be differentiated into 4 groups:
1. Patients with end-stage interstitial lung disease (ILD) and suspected stage I (up to 4 cm) primary lung cancer
2. Patients with end-stage lung disease other than ILD (e.g. emphysema/COPD, cystic fibrosis and pulmonary hypertension) and suspected stage I (up to 4 cm) primary lung cancer
3. Patients with multifocal primary lung cancer (e.g. multifocal adenocarcinoma) in the absence of nodal metastasis and distant metastasis.
4. Patients with isolated pulmonary metastasis in the absence of other sites of malignancy (primary and metastatic).
For this study, different doses will be used for each different group depending on their tumour size. The first 3 patients will start with a dose of 4 Gy, for the ILD group, or 8 Gy, for the non ILD group. The doses are then increased incrementally until the dose limiting toxicity is reached.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Lung cancer treatments work through various mechanisms to target and eliminate cancer cells. Surgery physically removes tumors, which is effective for localized disease.
Radiation therapy, including Non-ablative Oligofractionated Radiation Therapy (NORT), uses high-energy rays to destroy cancer cells and can stimulate an anti-tumoral immune response by creating heterogeneous dose distributions. Chemotherapy uses drugs to kill rapidly dividing cells, affecting both cancerous and healthy cells.
Targeted therapy focuses on specific genetic mutations within cancer cells, minimizing damage to normal cells. Immunotherapy boosts the body's immune system to recognize and attack cancer cells.
These treatments are crucial for lung cancer patients as they offer multiple strategies to control and potentially eradicate the disease, improving survival and quality of life.
Optimize Local Therapy for Oligometastatic and Oligoprogressive Non-Small Cell Lung Cancer to Enhance Survival.
Optimize Local Therapy for Oligometastatic and Oligoprogressive Non-Small Cell Lung Cancer to Enhance Survival.
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,520 Previous Clinical Trials
503,202 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition that may affect your ability to follow the treatment as required, according to the team's evaluation.My lung cancer is in early stage but can't be treated with surgery or targeted radiation.I had surgery to remove a lung tumor and have no other cancer spread that can be treated.I am under 18 years old.My cancer has spread to the lymph nodes in my chest, confirmed by a specific biopsy.My cancer has spread to distant parts of my body, confirmed by a scan.I am eligible for a lung transplant, ignoring my cancer diagnosis.I am 18 years old or older.I've had chest radiation before that makes more radiation risky.I have multiple lung cancer spots that cannot be removed or cured with surgery or targeted radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Radiation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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