Recruiting

SBRT

Sponsor:

McMaster University

Code:

NCT04160143

Conditions

Surgical Resection

Stereotactic Body Radiotherapy

Lung Cancer

Pulmonary Metastasectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Surgical resection and stereotactic body radiation therapy (SBRT)

Study Details

Brief summary:

The goal of this study is to determine the effectiveness of SBRT on reducing tumor viability at a pathologic level and also to evaluate the effects of combined modality treatment on low volume pulmonary metastases, in hopes of extrapolating this information to both primary and secondary lung cancer.

Conditions

Surgical Resection

Stereotactic Body Radiotherapy

Lung Cancer

Pulmonary Metastasectomy

Study ID

NCT04160143

Start date

Jul 14, 2020

Status verified date

Jan, 2021

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient age >18, resectable pulmonary metastases without a more effective systemic therapy option (regardless of type of primary malignancy, excluding hematologic malignancies) with the primary malignancy already having been treated without evidence of local recurrence
  • Patient having single-organ metastasis to lung only (with the exception of colorectal CA (Cancer) with synchronous hepatic metastasis)
  • Tumors <5cm
  • Patient with no evidence of nodal disease on pre-treatment CT scan
  • Patient having adequate pulmonary function to tolerate lung resection (post-operative predictive FEV1≥40%).

Exclusion Criteria:• Patient having comorbidities not amenable to surgery

  • Patient with uncontrolled primary malignancy
  • Patient with hematologic malignancies (leukemia or lymphoma)
  • Patient having more than 5 tumors in one lung
  • Patient with prior history of thoracic radiation
  • Patient having history of lung cancer diagnosis within 5 years of assessment

Study Design

Enrollment

39 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SBRT followed by pulmonary metastasectomy

SBRT+Surgery

Interventions

Surgical resection and stereotactic body radiation therapy (SBRT)

Surgical resection and stereotactic body radiation therapy (SBRT) are generally regarded as mutually exclusive treatment options for the local management of pulmonary malignancies. This Phase 2 prospective trial is a collaborative effort between the divisions of Thoracic Surgery and Radiation Oncology to evaluate the effects of dual treatment of pulmonary metastasis amenable to curative resection with neoadjuvant SBRT followed by surgical resection.

Primary outcome measure

  • Rates of complete pathologic response (pCR) [ Time Frame: post-operative 3 weeks ]

Central Contacts and Locations

Central contacts

Dr. John Agzarian, MD, MPH

(905) 522-1155agzarij@mcmaster.ca

Housne Begum, MSc, PhD

(905) 522-1155begumh@mcmaster.ca

Locations

McMaster University/St. Joseph's Hospital Healthcare

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contacts

John Agzarian, MD, FRCSC

905-522-1155agzarij@mcmaster.ca

Housne Begum, MSc, PhD

905-522-1155begumh@mcmaster.ca

More Information

Sponsor

McMaster University

Last update posted

Feb 25, 2021

Last verified

Jan, 2021

Keywords

  • Surgical resection
  • Stereotactic body radiation therapy
  • Pulmonary metastasectomy
  • Lung Cancers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2021-02-25.