Stereotactic Radiotherapy (SBRT) of Lung Metastasis

NCT01803542 | Recruiting Phase 2

• 1 other identifier: 05-0951
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Determine local control in patients treated with SBRT.

  10 years

• Determine pattern of relapse in patients treated with SBRT.

  10

• Determine survival rates in patients treated with SBRT.

  10

Secondary Outcomes (8)

• To characterize acute and late toxicity

  10 years

• Assess the use of PET/CT in aiding target definition and predicting local response

  10 years

• Assess the use of Cone Beam CT for precision imaging of the target and avoidance structures at each treatment

  10 years

• Assess the use of 4D-computed tomography (CT) planning to determine Internal Treatment Volume (ITV) and Planning Treatment Volume (PTV)

  10 years

• Develop organ motion prediction models

  10 years

Study Arms (1)

SBRT

EXPERIMENTAL

High dose of radiation will be used to treat tumours.

Radiation: Stereotactic Radiation

Interventions

Stereotactic Radiation 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.

SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Princess Margaret Hospital, Canada: collaborator
• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Hospital, University Health Network

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• John Cho, MD

  University Health Network, Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Cho, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: March 4, 2013
• Study Start: March 1, 2006
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

CA (1)