Post-operative Radiotherapy for Lung Cancer
(RESCUE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether adding radiotherapy (a type of cancer treatment using radiation) after lung cancer surgery can help patients with stage III non-small cell lung cancer (NSCLC) live longer without cancer recurrence. It targets those who still have some cancer remaining after receiving a combination of chemotherapy and immunotherapy before surgery. The trial compares outcomes between patients who receive radiotherapy and those who do not. Ideal participants have undergone lung cancer surgery, still have cancer in their lymph nodes, and have not previously received chest radiotherapy. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that post-operative radiotherapy is safe for patients with stage III non-small cell lung cancer?
Research shows that post-operative radiotherapy (PORT) is usually manageable for patients. Studies have found that many patients experience side effects that can be controlled. Although some studies did not find that PORT significantly improves survival rates for lung cancer, they also did not identify major safety issues.
For instance, one study involving patients with non-small cell lung cancer (NSCLC) found no significant difference in safety between those who received PORT and those who did not. This indicates that the treatment does not greatly increase the risk of serious side effects. However, like any treatment, some patients might experience mild or moderate side effects, such as fatigue or skin irritation.
Overall, PORT is considered safe for many patients, but discussing potential risks with a doctor is important to understand its implications personally.12345Why are researchers excited about this trial's treatment?
Researchers are excited about post-operative radiotherapy for lung cancer because it specifically targets the mediastinal area with a focused dose of 40 Gy in 15 fractions. Unlike standard care, which often involves a broader approach with systemic therapies or different radiotherapy protocols, this method may provide more precise treatment after surgery. The excitement lies in the potential for enhanced effectiveness in reducing cancer recurrence rates with fewer side effects by concentrating on the area most at risk post-surgery.
What evidence suggests that post-operative radiotherapy might be an effective treatment for stage III non-small cell lung cancer?
Research has shown that postoperative radiotherapy (PORT) can benefit some lung cancer patients. Specifically, for those with non-small cell lung cancer (NSCLC), PORT helps control the cancer locally, delays its progression, and improves overall survival in high-risk cases. In this trial, one group of participants will receive PORT, which has improved survival rates for patients with ypN2 NSCLC who have undergone chemotherapy and surgery. However, some studies suggest that PORT might not always enhance survival in NSCLC. It appears most helpful for patients with certain risk factors, such as when cancer cells remain after surgery. Another group in this trial will not receive PORT, allowing for a comparison of outcomes.23678
Are You a Good Fit for This Trial?
This trial is for adults with stage III non-small cell lung cancer (NSCLC) who've had chemo-immunotherapy and surgery but still have some disease left. They must be able to consent, have a performance status of 0-2 (able to carry out daily activities), no specific gene mutations that can be targeted by other treatments, and complete staging including PET and brain scans.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Chemo-immunotherapy
Participants receive neoadjuvant chemo-immunotherapy before surgery
Surgery
Participants undergo thoracic surgery to remove residual disease
Post-operative Radiotherapy
Participants receive mediastinal PORT (40 Gy in 15 fractions) within 24 weeks from thoracic surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Post-operative Radiotherapy
Trial Overview
The study tests if post-operative radiotherapy (PORT) targeting lymph nodes improves event-free survival in NSCLC patients after initial treatment. It's a phase II trial where half the patients will receive PORT. The goal is to see if there's at least a 15% improvement in survival without events like cancer progression or death after two years.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Mediastinal PORT (40 Gy in 15 fractions) within 24 weeks from thoracic surgery
No post-operative radiotherapy (PORT)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
Citations
a single-centre, randomized, phase 3 trial
Several meta-analyses have shown that postoperative radiotherapy (PORT) has no effect on the survival improvement for patients with non-small-cell lung cancer ( ...
Postoperative radiotherapy in non-small-cell lung cancer
We report an updated systematic review and individual patient data meta-analysis of the effectiveness of postoperative radiotherapy (PORT) in non-small-cell ...
Postoperative radiotherapy and survival outcomes in pN2 ...
Postoperative radiotherapy and survival outcomes in pN2 non-small-cell lung cancer with positive surgical margins: An updated review of the ...
Is postoperative radiotherapy effective in patients with ...
This study showed that PORT improves local control, PFS and OS in completely resected p-IIIA (N2) NSCLC at high risk of LRR.
Postoperative radiotherapy enhances survival in NSCLC ...
Postoperative radiotherapy improves survival of patients with ypN2 non-small cell lung cancer after neoadjuvant chemotherapy followed by surgery ...
a single-centre, randomized, phase 3 trial
The 5-year DFS rates in the PORT and observation arms were 36% (95% confidence interval [CI], 28.9%-43.1%) and 31.5% (95% CI, 24.6%-38.4%), respectively; the 5- ...
Clinical Outcomes and Predictive Factors in NSCLC after ...
A total of 84 patients (32.9%) died over the course of the follow-up, resulting in a calculated median OS of 51 months (SD: 4.54 months; 95% CI, ...
8.
journals.lww.com
journals.lww.com/md-journal/fulltext/2025/07250/postoperative_radiotherapy_enhances_survival_in.54.aspxPostoperative radiotherapy enhances survival in NSCLC...
The median OS times were 47.0 months (IQR: 20.0–115.0) for the low-risk group, 33.0 months (IQR: 17.0–80.0) for the moderate-risk group, and ...
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