Surgical resection and stereotactic body radiation therapy (SBRT) for Lung Cancer
Phase-Based Progress Estimates
Effectiveness
Safety
McMaster University/St. Joseph's Hospital Healthcare, Hamilton, CanadaLung Cancer+3 MoreSurgical resection and stereotactic body radiation therapy (SBRT) - Procedure
Study Summary
This trial is testing whether a particular type of radiation therapy can help to shrink tumors and improve outcomes for people with lung cancer.
Eligible Conditions
- Lung Cancer
- Surgical Resection
- Pulmonary Metastasectomy
- Stereotactic Body Radiotherapy
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: post operative 3 years
Week 12
The effect on time-to-resection and tumour histology on pCR
Week 6
Identify mRNA tumor markers by Circulating Tumor Cell/CTC test
Year 3
Disease-free survival (DFS)
Post operative 3 years
Overall survival (OS)
Post radiation 1 year
Radiation related toxicity
post operative 3 years
local recurrence rates
post operative 30 days
Postoperative pulmonary complication rate (including prolonged air leak, need for invasive or noninvasive mechanical ventilation, postop pneumonia and empyema)
post-operative 3 weeks
Rates of complete pathologic response (pCR)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
SBRT followed by pulmonary metastasectomy
1 of 1
Experimental Treatment
39 Total Participants · 1 Treatment Group
Primary Treatment: Surgical resection and stereotactic body radiation therapy (SBRT) · No Placebo Group · N/A
SBRT followed by pulmonary metastasectomy
Procedure
Experimental Group · 1 Intervention: Surgical resection and stereotactic body radiation therapy (SBRT) · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: post operative 3 years
Who is running the clinical trial?
McMaster UniversityLead Sponsor
823 Previous Clinical Trials
1,732,393 Total Patients Enrolled
John Agzarian, MD, MPHPrincipal InvestigatorMcMaster University
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have cancer that has only spread to your lungs and not to any other organs, except for colorectal cancer that has spread to your liver at the same time.
You are over 18 years old and have cancer that has spread to your lungs, which can be completely removed with surgery. You have already received treatment for your primary cancer without any signs of it coming back. There are no other better treatment options available for you.
References
- Chang, Joe Y, Suresh Senan, Marinus A Paul, Reza J Mehran, Alexander V Louie, Peter Balter, Harry J M Groen, et al.. 2015. “Stereotactic Ablative Radiotherapy Versus Lobectomy for Operable Stage I Non-small-cell Lung Cancer: A Pooled Analysis of Two Randomised Trials”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(15)70168-3.
- Ibrahim, Tony, Lambros Tselikas, Charbel Yazbeck, and Joseph Kattan. 2016. “Systemic Versus Local Therapies for Colorectal Cancer Pulmonary Metastasis: What to Choose and When?”. Journal of Gastrointestinal Cancer. Springer Science and Business Media LLC. doi:10.1007/s12029-016-9818-4.
- Widder, Joachim, Theo J. Klinkenberg, Jan F. Ubbels, Erwin M. Wiegman, Harry J.M. Groen, and Johannes A. Langendijk. 2013. “Pulmonary Oligometastases: Metastasectomy or Stereotactic Ablative Radiotherapy?”. Radiotherapy and Oncology. Elsevier BV. doi:10.1016/j.radonc.2013.05.024.
- Filippi, A.R., F. Guerrera, S. Badellino, M. Ceccarelli, A. Castiglione, A. Guarneri, R. Spadi, et al.. 2016. “Exploratory Analysis on Overall Survival After Either Surgery or Stereotactic Radiotherapy for Lung Oligometastases from Colorectal Cancer”. Clinical Oncology. Elsevier BV. doi:10.1016/j.clon.2016.02.001.
- Junker, Klaus, Kathrin Langner, Folker Klinke, Ulrich Bosse, and Michael Thomas. 2001. “Grading of Tumor Regression in Non-small Cell Lung Cancer”. Chest. Elsevier BV. doi:10.1378/chest.120.5.1584.
- Cox, James D., JoAnn Stetz, and Thomas F. Pajak. 1995. “Toxicity Criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC)”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/0360-3016(95)00060-c.
- Prezzano, Kavitha M, Sung Jun Ma, Gregory M Hermann, Charlotte I Rivers, Jorge A Gomez-Suescun, and Anurag K Singh. 2019. “Stereotactic Body Radiation Therapy for Non-small Cell Lung Cancer: A Review”. World Journal of Clinical Oncology. Baishideng Publishing Group Inc.. doi:10.5306/wjco.v10.i1.14.
- Begum, Housne, Anand Swaminath, Yung Lee, Christine Fahim, Jonathan Bramson, Asghar Naqvi, Yaron Shargall, Christian Finley, Wael Hanna, and John Agzarian. 2022. “The Histologic Effects of Neoadjuvant Stereotactic Body Radiation Therapy (SBRT) Followed by Pulmonary Metastasectomy—rationale and Protocol Design for the Post SBRT Pulmonary Metastasectomy (PSPM) Trial”. Translational Cancer Research. AME Publishing Company. doi:10.21037/tcr-22-232.
- Chang JY, Senan S, Paul MA, Mehran RJ, Louie AV, Balter P, Groen HJ, McRae SE, Widder J, Feng L, van den Borne BE, Munsell MF, Hurkmans C, Berry DA, van Werkhoven E, Kresl JJ, Dingemans AM, Dawood O, Haasbeek CJ, Carpenter LS, De Jaeger K, Komaki R, Slotman BJ, Smit EF, Roth JA. Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: a pooled analysis of two randomised trials. Lancet Oncol. 2015 Jun;16(6):630-7. doi: 10.1016/S1470-2045(15)70168-3. Epub 2015 May 13. Erratum In: Lancet Oncol. 2015 Sep;16(9):e427.
- Cox JD, Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6. doi: 10.1016/0360-3016(95)00060-C. No abstract available.
- Junker K, Langner K, Klinke F, Bosse U, Thomas M. Grading of tumor regression in non-small cell lung cancer : morphology and prognosis. Chest. 2001 Nov;120(5):1584-91. doi: 10.1378/chest.120.5.1584.
- Prezzano KM, Ma SJ, Hermann GM, Rivers CI, Gomez-Suescun JA, Singh AK. Stereotactic body radiation therapy for non-small cell lung cancer: A review. World J Clin Oncol. 2019 Jan 10;10(1):14-27. doi: 10.5306/wjco.v10.i1.14.
- Ibrahim T, Tselikas L, Yazbeck C, Kattan J. Systemic Versus Local Therapies for Colorectal Cancer Pulmonary Metastasis: What to Choose and When? J Gastrointest Cancer. 2016 Sep;47(3):223-31. doi: 10.1007/s12029-016-9818-4.
- 2020. "Post SBRT Pulmonary Metastasectomy (PSPM) Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04160143.
Frequently Asked Questions
Are recruitment efforts still underway for this research project?
"According to clinicaltrials.gov, this research is still looking for participants; the trial was initially posted on July 14th 2020 and has been amended most recently on February 23rd 2021." - Anonymous Online Contributor
Unverified Answer
How many participants are receiving treatment within this trial?
"Affirmative. Clinicaltrials.gov confirms that this clinical study, which was launched on July 14th 2020, is still recruiting participants. Approximately 39 individuals need to be enrolled from a single site." - Anonymous Online Contributor
Unverified Answer