Study on Targeted Radiation Therapy After Surgery for Non-Small Cell Lung Cancer with Remaining Lymph Node Cancer
Sponsor: Alliance for Clinical Trials in Oncology
ClinicalTrials ID:NCT07293247
This clinical trial is exploring whether adding a specific type of radiation therapy after surgery can improve outcomes for patients with non-small cell lung cancer (NSCLC) who still have cancer in their lymph nodes after surgery. The study compares this approach to the usual treatment of chemotherapy or immunotherapy alone.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to see if using a special type of radiation therapy called intensity-modulated radiation therapy (I²-PORT) after surgery can help prevent cancer from coming back in patients with non-small cell lung cancer (NSCLC) who have remaining cancer in their lymph nodes. This radiation therapy uses advanced technology to target the tumor precisely, minimizing damage to nearby healthy tissue. The study will compare the effectiveness of this radiation therapy combined with standard treatments like chemotherapy or immunotherapy against using standard treatments alone.
Description
The main goals of this study are to determine if adding intensity-modulated post-operative radiation therapy (I²-PORT) can improve the time patients remain free from cancer after surgery and to ensure it does not significantly increase severe heart or lung side effects.
Secondary goals include evaluating long-term survival rates, control of cancer spread, and monitoring any side effects related to the heart and lungs. The study will also look at patient-reported symptoms like pain and breathing difficulties.
Participants will be randomly assigned to one of two groups:
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Group 1: Will receive standard chemotherapy or immunotherapy. They will also have regular scans and blood tests to monitor their health.
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Group 2: Will receive the I²-PORT radiation therapy daily from Monday to Friday for 5-6 weeks, starting a few weeks after surgery. After completing radiation, they will also receive standard chemotherapy or immunotherapy. Regular scans and blood tests will be conducted to track their progress.
After finishing the treatment, participants will have follow-up visits every 3 months for the first 2 years, and then every 6 months for the next 3 years to monitor their health and any signs of cancer returning.
Eligibility Criteria
- Histopathologic diagnosis of NSCLC, may have mixed or multiple histologies but no small cell component
- No known EGFR mutation or ALK rearrangement
- No metastatic disease (M0) per most recent PET/CT and head CT/MRI imaging
- No disease progression per CT chest (including upper abdomen as per standard practice) with intravenous (IV) contrast (unless IV contrast is contraindicated) or FDG-PET performed post-neoadjuvant therapy ≤ 90 days prior to registration, either before or after surgery
- No metastatic disease (M0) per head CT/MRI imaging
- Prior treatment with 2-4 cycles of neoadjuvant systemic therapy with any guideline (National Comprehensive Cancer Network [NCCN]) concordant regimen
- Lobectomy or greater oncologic surgical resection within 8 weeks prior to registration
- Complete (R0) resection showing ypN2 disease
- No prior radiotherapy to the lungs or mediastinum
- No treatment with a VEGF inhibitor ≤ 90 days prior to registration or plan to treat with adjuvant systemic therapy including a VEGF inhibitor
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Absolute neutrophil count (ANC) ≥ 1,000/mm^3
- Platelet count ≥ 50,000/mm^3
- Calculated (Calc.) creatinine clearance ≥ 30 mL/min
- Total bilirubin ≤ 3 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 5 x upper limit of normal (ULN)
- Not pregnant, because this study involves radiation therapy, which has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to registration is required
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Cardiac function: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
- No idiopathic pulmonary fibrosis requiring anti-fibrotic medication: Patients with idiopathic pulmonary fibrosis or inflammatory/interstitial lung disease compromising pulmonary function or requiring ongoing treatment with nintedanib, pirfenidone, or other anti-fibrotic drug are excluded
- HIV-infected patients on effective anti-retroviral therapy with an undetectable viral load within 6 months are eligible for this trial
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cancer Care Specialists of Illinois - Decatur | 62526 | Decatur | Illinois |
| Decatur Memorial Hospital | 62526 | Decatur | Illinois |
| Cancer Care Center of O'Fallon | 62269 | O'Fallon | Illinois |
| HSHS Saint Elizabeth's Hospital | 62269 | O'Fallon | Illinois |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor | 48106 | Ann Arbor | Michigan |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton | 48114 | Brighton | Michigan |
| Trinity Health Medical Center - Brighton | 48114 | Brighton | Michigan |
| Trinity Health IHA Medical Group Hematology Oncology - Canton | 48188 | Canton | Michigan |
| Trinity Health Medical Center - Canton | 48188 | Canton | Michigan |
| Chelsea Hospital | 48118 | Chelsea | Michigan |
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