Post SBRT Pulmonary Metastasectomy (PSPM) Trial

NCT04160143 | Unknown DMC

• 1 other identifier: SJHH_PSPM
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rates of complete pathologic response (pCR)

  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.

  post-operative 3 weeks

Secondary Outcomes (7)

• Overall survival (OS)

  Post operative 3 years

• Disease-free survival (DFS)

  Disease-free survival (DFS) at 3 years

• local recurrence rates

  post operative 3 years

• Radiation related toxicity

  Post radiation 1 year

• Postoperative pulmonary complication rate (including prolonged air leak, need for invasive or noninvasive mechanical ventilation, postop pneumonia and empyema)

  post operative 30 days

Study Arms (1)

SBRT followed by pulmonary metastasectomy

EXPERIMENTAL

SBRT+Surgery

Procedure: Surgical resection and stereotactic body radiation therapy (SBRT)

Interventions

Surgical resection and stereotactic body radiation therapy (SBRT) PROCEDURE

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.

SBRT followed by pulmonary metastasectomy

Eligibility Criteria

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

You may qualify if:

• 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%).

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University/St. Joseph's Hospital Healthcare

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

Related Publications (8)

• 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.

  PMID: 25981812 BACKGROUND

• 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.

  PMID: 30627522 BACKGROUND

• 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.

  PMID: 27080402 BACKGROUND

• Widder 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 BACKGROUND

• Filippi 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 BACKGROUND

• 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.

  PMID: 11713138 BACKGROUND

• 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.

  PMID: 7713792 BACKGROUND

• Begum H, Swaminath A, Lee Y, Fahim C, Bramson J, Naqvi A, Shargall Y, Finley C, Hanna W, Agzarian J. 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. Transl Cancer Res. 2022 Apr;11(4):918-927. doi: 10.21037/tcr-22-232.

  PMID: 35571641 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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 Agzarian, MD, MPH

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. John Agzarian, MD, MPH

CONTACT

(905) 522-1155; agzarij@mcmaster.ca

Housne Begum, MSc, PhD

CONTACT

(905) 522-1155; begumh@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This innovative study is an open-label unblinded single-arm prospective trial evaluating induction SBRT followed by pulmonary metastasectomy. As a Phase 2 trial, the primary purpose is to assess the efficacy of SBRT on metastatic tumor viability and the safety of SBRT as induction treatment prior to surgery

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 12, 2019
• Study Start: July 14, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)