Stereotactic Radiotherapy for Lung Metastasis
Lung Stereotactic Radiation Therapy for Patients With Non-small Cell Lung Cancer and Other Cancers
This study is testing whether a special type of radiation therapy can help shrink lung tumors in patients with non-small cell lung cancer and other cancers that have spread to the lungs.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT01803542 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Stereotactic Body Radiation Therapy (SBRT) in treating lung tumors, particularly in patients with non-small cell lung cancer and metastases from other cancers. Participants will receive high doses of radiation over a short period, with the aim of refining treatment techniques and standardizing follow-up care. The study will monitor the effectiveness of SBRT in shrinking tumors and controlling cancer, as well as the frequency of side effects experienced by patients. SBRT is guided by precise imaging techniques to ensure accurate targeting of tumors.
Who should consider this trial
Good fit: Ideal candidates include patients with stage I or II non-small cell lung cancer or those with controlled non-lung cancers that have metastasized to the lungs.
Not a fit: Patients with extensive metastatic disease or those whose tumors do not meet the size criteria for SBRT may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for controlling lung tumors and improving patient outcomes.
How similar studies have performed: Previous studies have shown promising results with SBRT, indicating its potential effectiveness in treating lung tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histological confirmation of malignancy, unless the risks of biopsy are unacceptable and the lesion has grown on serial CT scan and/or is PET positive. * Eligible patients must have staging studies (e.g. chest radiograph, CT scan, MRI/CT Brain/Bone Scan) identifying them as: * patients with stage I or II, non-metastatic NSCLC (T1, N0, M0; T2, N0, M0; or T3, N0, M0 chest wall primary tumors only) * patients with a non-lung primary that is controlled and which has metastasized to the lungs alone, in whom potentially curative surgery would otherwise be an option (e.g. colorectal, breast, sarcoma…etc) * the subset of patients with limited (low) volume metastatic NSCLC or other primary site tumors whom it is felt may derive benefit from highdose SBRT treatment to the primary or metastatic lung tumor. And in whom other sites of metastatic disease are being treated with the desire to achieve long term control. Lesions must meet size criteria in 4.1.2.1 * Patients who have potentially resectable disease should be considered medically inoperable, or else in the judgement of the thoracic surgeon and lung team, surgery is not considered the preferred management option * Early stage lung cancer: ≤3 parenchymal lung lesions, Metastatic disease to lungs: ≤5 parenchymal lung lesions * Patients with early stage primary NSCLC should have hilar or mediastinal lymph nodes that are considered N0 on clinico-radiological grounds (i.e. no clinico-radiological evidence of lymph node spread) * In patients with early stage primary NSCLC and a co-existing malignancy, the co-existing malignancy must have an expected prognosis better than primary lung lesion * Adequate lung function to tolerate the planned stereotactic radiation * Previous conventional RT to mediastinum/lung allowed as long as SBRT is not expected to have a high probability of impairing lung function * Must be ≥ 18 years of age * Zubrod performance status must be between 0 and 3 * Women of child bearing potential and male participants must use an effective contraceptive method * Willing and able to give informed consent Exclusion Criteria: * Patients with active systemic, pulmonary or pericardial infection * No concurrent systemic therapy (chemotherapy, immunotherapy or biological therapy), apart from hormone therapy, is allowed * History of active auto-immune diseases, including systemic lupus erythematous, rheumatoid arthritis, C.R.E.S.T., systemic sclerosis,scleroderma * Potential candidate for concurrent chemo-radiation therapy * Patient enrollment on other studies may be permissible. This will depend on patient and study characteristics.
Where this trial is running
Toronto, Ontario
- Princess Margaret Hospital, University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: John Cho, MD — University Health Network, Princess Margaret Hospital
- Study coordinator: John Cho, MD
- Email: John.Cho@rmp.uhn.on.ca
- Phone: 416 946 2124
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.