Recruiting
Phase 2

SBRT

Sponsor:

University Health Network, Toronto

Code:

NCT01803542

Conditions

Non-small Cell Lung Cancer

Metastasis From Other Cancers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Radiation

Study Details

Brief summary:

The purpose of this institutional protocol is to offer SBRT to selected patients in a controlled environment to refine treatment techniques (including dose/fractionation schedules) and standardize follow-up. SBRT has been in clinical use for over a decade in some institutions and the available data suggest that it can be used safely and with good results. This study will see how effective Stereotactic Body Radiation Therapy is for treating tumours in the lung and how often people have side effects. Radiation therapy is usually given once a day, often for a few weeks. In this study, study participants will receive high doses of radiation treatment to tumours in the lung for 3 to 10 treatment sessions over a total of about 1 to 2 weeks.

Several reports indicate that this therapy might shrink tumours and control the cancer for extended periods of time. Although specialists started to treat patients with SBRT over 10 years ago, it is still used in relatively few cancer centres.

Conditions

Non-small Cell Lung Cancer

Metastasis From Other Cancers

Study ID

NCT01803542

Start date

Mar, 2006

Status verified date

Mar, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SBRT

High dose of radiation will be used to treat tumours.

Interventions

Stereotactic Radiation

Participants will receive high doses of radiation treatment to tumours in the lung for 3 to 10 treatment sessions over a total of about 1 to 2 weeks.

Primary outcome measure

  • Determine local control in patients treated with SBRT. [ Time Frame: 10 years ]
  • Determine pattern of relapse in patients treated with SBRT. [ Time Frame: 10 ]
  • Determine survival rates in patients treated with SBRT. [ Time Frame: 10 ]

Central Contacts and Locations

Central contacts

John Cho, MD

416 946 2124John.Cho@rmp.uhn.on.ca

Locations

Princess Margaret Hospital, University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

John Cho, MD

416 946 2124John.Cho@rmp.uhn.on.ca

Principal Investigator:

John Cho, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

  • Non-small Cell Lung Cancer
  • Stereotactic radiation for Lung Cancer
  • Cone beam CT for Lung Cancer
  • PET/CT for Lung Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-06.