Clinical trial · Interventional
Post SBRT Pulmonary Metastasectomy (PSPM) Trial
Evaluating the Histologic Effects of Neoadjuvant Stereotactic Body Radiation Therapy (SBRT) Followed by Pulmonary Metastasectomy-Post SBRT Pulmonary Metastasectomy (PSPM) Trial
NCT04160143CI-TRIAL-00050322PSPMunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Pulmonary Metastasectomy | Lung Neoplasm | PROBABILISTIC | 0.70 |
| Stereotactic Body Radiotherapy | — | UNRESOLVED | — |
| Surgical Resection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgical resection and stereotactic body radiation therapy (SBRT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT followed by pulmonary metastasectomy
- description
- SBRT+Surgery
- interventionNames
- Procedure: Surgical resection and stereotactic body radiation therapy (SBRT)
Primary outcomes (1)
- measure
- Rates of complete pathologic response (pCR)
- timeFrame
- post-operative 3 weeks
- description
- pCR in surgical specimens post SBRT as assessed using the Junker grading scale for lung malignancies: Grade I, no regression or only spontaneous tumor regression; Grade II, morphologic evidence of tumor regression with at least 10% (grade IIa) or \<10% (grade IIb) viable tumor tissue; and Grade III, complete tumor regression with no viable tumor.
Secondary outcomes (7)
- measure
- Overall survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDChang 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. PMID 25981812
- BACKGROUNDPrezzano 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. PMID 30627522
- BACKGROUNDIbrahim 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. PMID 27080402
- BACKGROUNDWidder J, Klinkenberg TJ, Ubbels JF, Wiegman EM, Groen HJ, Langendijk JA. Pulmonary oligometastases: metastasectomy or stereotactic ablative radiotherapy? Radiother Oncol. 2013 Jun;107(3):409-13. doi: 10.1016/j.radonc.2013.05.024. Epub 2013 Jun 14. PMID 23773410
- BACKGROUNDFilippi AR, Guerrera F, Badellino S, Ceccarelli M, Castiglione A, Guarneri A, Spadi R, Racca P, Ciccone G, Ricardi U, Ruffini E. Exploratory Analysis on Overall Survival after Either Surgery or Stereotactic Radiotherapy for Lung Oligometastases from Colorectal Cancer. Clin Oncol (R Coll Radiol). 2016 Aug;28(8):505-12. doi: 10.1016/j.clon.2016.02.001. Epub 2016 Feb 18. PMID 26899780
- BACKGROUNDJunker 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.