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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to four years

Awards & highlights

NORTh STAR Trial Summary

This trial is testing a new way to give radiation therapy to people with cancer before they get a lung transplant. The hope is that this will help keep the cancer from 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.Check my eligibility

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.See study design

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.

NORTh STAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is in early stage but can't be treated with surgery or targeted radiation.

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I had surgery to remove a lung tumor and have no other cancer spread that can be treated.

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I am 18 years old or older.

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I have multiple lung cancer spots that cannot be removed or cured with surgery or targeted radiation.

NORTh STAR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to four years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to four years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to four years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose for Radiation

Secondary outcome measures

Local recurrence

Patient Morbidity

NORTh STAR Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental: RadiationExperimental Treatment1 Intervention

Patients will be differentiated into 4 groups: Patients with end-stage interstitial lung disease (ILD) and suspected stage I (up to 4 cm) primary lung cancer 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 Patients with multifocal primary lung cancer (e.g. multifocal adenocarcinoma) in the absence of nodal metastasis and distant metastasis. 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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,138 Total Patients Enrolled

Media Library

Radiation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04782752 — N/A

Lung Cancer Research Study Groups: Experimental: Radiation

Lung Cancer Clinical Trial 2023: Radiation Highlights & Side Effects. Trial Name: NCT04782752 — N/A

Radiation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04782752 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being monitored for this experimental treatment?

"Affirmative. Information found on clinicaltrials.gov shows that this medical trial, which was posted for the first time on April 28th 2021 is actively accepting candidates. Approximately 42 people need to be enrolled at one centre."

Answered by AI

Is this research currently seeking out participants?

"According to the data made available on clinicaltrials.gov, this trial is ongoing and recruiting patients; it was initially posted on April 28th 2021, with its most recent edit being conducted at June 6th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Non-ablative Oligofractionated Radiation Therapy Before Surgical Transplantation As Radiovaccination

2021. "Non-ablative Oligofractionated Radiation Therapy Before Surgical Transplantation As Radiovaccination". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04782752.