Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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.

Surgical resection and stereotactic body radiation therapy (SBRT)

Dr. John Agzarian, MD, MPH

Housne Begum, MSc, PhD

John Agzarian, MD, FRCSC

John Agzarian, MD, MPH

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.

The role of SBRT as a potentially non-invasive treatment for small-volume tumors in the lung is well established, but the effectiveness of tumor eradication has yet to be determined. This prospective Phase 2 trial will provide several novel contributions to the literature: 1) the assessment of SBRT effectiveness in metastatic tumor control (radiotherapeutic metastasectomy), 2) the evaluation of pathologic response to SBRT by surgical resection, 3) identification of histologic predictors of radiation effect and toxicity (i.e. what are the effects of SBRT on different type of metastatic disease), and 4) the effect of combined modality SBRT and surgery on survival and local recurrence as compared to either modality alone. This trial will uniquely assess whether surgery as an adjunct to radiotherapy offers better tumor control as compared to SBRT alone, and whether it decreases locoregional recurrence. The study is an open-label unblinded single-arm prospective trial evaluating induction SBRT followed by pulmonary metastasectomy. This 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. Study recruitment and analysis will be conducted at St. Joseph Healthcare Hamilton and the Juravinski Cancer Center. Institutional data suggests that the Division of Thoracic Surgery at McMaster University performs an average of 450 pulmonary resections per year with approximately 10-15% being pulmonary metastasectomies for a spectrum of malignancies (including colorectal carcinoma, renal cell carcinoma and soft tissue sarcoma).

Surgical resection and stereotactic body radiation therapy (SBRT) are generally regarded as mutually exclusive treatment options for the local management of pulmonary malignancies. The Primary Outcome will be measured as the Rates of complete pathologic response (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. The Secondary Outcomes: Overall survival (OS) at 3 years, Disease-free survival (DFS) at 3 years, local recurrence rates, radiation related toxicity, postoperative pulmonary complication rate (including prolonged air leak, need for invasive or noninvasive mechanical ventilation, postop pneumonia and empyema), the effect on time-to-resection and tumour histology on pCR. In addition, it will be explored whether cancer specific tumor biomarkers correlate with SBRT effects and related toxicity. Based on institutional data from other local prospective trials, the Thoracic Surgery division at McMaster averages a study accrual rate of 25-30% and retention rate of approximately 80%. The most pertinent metric in determining the necessary sample size is the effect size estimate of pCR. The MISSILE study preliminary data demonstrated a pCR of 60%. This serves as the only representative value in the literature, even though our study evaluates SBRT and surgery for metastatic disease and NOT primary lung cancer. In contrast, the SBRT literature (using post-treatment CT scan surveillance only) reports local control rates of nearly 90%. Using the Fleming procedure, in order to measure the true pCR with a 95% confidence interval ± 10% using an estimated true pCR of 70%, estimated dropout rate of 20%, and 80% power, the calculated sample size requirement is 39 patients. It is estimated being able to recruit approximately 1-2 patients per month.

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

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

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.

Followup over all survival (OS) at 3 years

Followup over all survival (OS) at 3 years. Based on 1. clinical 2. CT scan results

Follow Radiation Therapy Oncology Group (RTOG) Common Toxicity Criteria (Cox, 1995)

Using Society of Thoracic Surgery (STS) Database

Identify mRNA tumor markers for circulating tumor cell/CTC detection from blood sample to get cancer specific tumor biomarkers correlate with SBRT effects including different targeted gene such MUC1, HER2, EPCAM, ER/PR for Breast Cancer, PSA, PSMA, EGFR, AR for Prostate Cancer, EPCAM, EGFR, CEA for Colon Cancer, EPCAM, MUC1, CA125, ERCC1 for Ovarian Cancer and Stemcell . The CTC test will be doing to get information about whether or not disease has disseminated from the primary site and mainly as a prognostic and/or predictive marker in the metastatic settings. This test will be done in baseline or Pre SBRT, Post SBRT and Post Surgery.

McMaster University

Digestive System Diseases

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Pancreatic Neoplasms

Melanoma

Glioblastoma

Death

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

Stomach Diseases

Stomach Cancer

Pancreatic Cancer

Neuroepithelioma

Oncologists trained using OncoTalk to have Goals of Care discussions.

Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.

GoC intervention

Nina Bickell, MD, MPH

The goal of this study is to increase and improve Goals of Care discussions for advanced cancer patients by training medical oncologists to conduct these discussions. The investigators will evaluate the GoC discussion's effects on patient satisfaction, receipt of treatment in line with preferences, use of aggressive treatment, and oncologist communication skill.

Among advanced cancer patients, discussions about prognosis, goals of care (GoC) and end-of-life preferences improve quality of life of patients and reduce rates of hospital and ICU admission. Yet, few patients know their chemotherapy treatments will not cure their disease despite nearly all wishing to receive information- good \& bad. Currently, 37% of advanced cancer patients have GoC clarifying discussions and when they do, it is often in the last 2 months of life when symptoms are uncontrollable and oncologists have no other treatments to offer. These discussions do not usually happen with the patient's personal oncologist. Current efforts to teach oncologists such skills are impractical, requiring a lot of time away from their office practice and do not take into account job pressures.

The goal of this study is to increase and improve GoC discussions for advanced cancer patients by training medical oncologists to conduct these discussions and evaluate its effects on patient satisfaction, receipt of care in line with preferences, aggressive care utilization, and oncologist communication skill.

The investigators will recruit 280 patients of which half will come from intervention doctors and the other from the control doctors. The investigators will train randomly selected oncologists to conduct GoC discussion. Patients will be surveyed at baseline within days of their GOC visit and at 6 months. Oncologists will be audio-taped at baseline and after training is complete to assess practice and skill to conduct GoC discussions.

Primary outcomes include patient reported conduct of and satisfaction with GoC discussion. Secondary outcomes include oncologist communication skills, feasibility of performing GoC in the outpatient setting, receipt of care in line with preferences, use of hospice, chemotherapy or ICU in the last 30 days of life.

Improving Goals of Care Discussion in Advanced Cancer Patients

Improving Advanced Cancer Patient-Centered Care by Enabling Goals of Care Discussions

Number of patient's perceptions that goals of care discussions were increased occurred as measured by GoC qualitative patient survey.

Number of Patient's satisfaction with the discussion of improved goals of care as measured by GoC qualitative patient survey.

Oncologist's communication skills are tested and rated between 1 and 7, with higher number indicating the oncologists were more comfortable in demonstrating communication skills while having the Goals of Care discussion with their patients.

Patient-Centered Outcomes Research Institute

Icahn School of Medicine at Mount Sinai

Adverse events were not monitored/assessed

Patients given OncoTalk GoC intervention

GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.

Patients - GoC Intervention

Prospective control group where no intervention was given.

Patients - Usual Care

Oncologists - GoC Intervention

Oncologists not trained using OncoTalk to have Goals of Care discussions.

Oncologists - Usual Care

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Data was collected for patient participants only

Radhi Yagnik

Oncologist - GoC Intervention

Data from patient participants only. Data not collected from Oncologists

Number of Participants Who Perceived Increased Goals of Care Discussions

Patients given OncoTalk GoC intervention.

GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.

Data collected for patient participants only

Number of Patients Perception of Improved Goals of Care Discussions

Oncologists trained using OncoTalk to have Goals of Care discussions.

GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.

Participants represented are the oncologist's. Data collected for the oncologists only.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Post SBRT Pulmonary Metastasectomy (PSPM) Trial	NCT04160143	Surgical Resect... Stereotactic Bo... Lung Cancer Pulmonary Metas...	Surgical resect...	18 Years -	McMaster University
Improving Goals of Care Discussion in Advanced Cancer Patients	NCT02374255	Primary Stage I... Esophageal Colorectal Canc... Glioblastoma Cancer of Stoma... Cancer of Pancr... Melanoma Head or Neck Ca... Stage III Stage IV Lung Cancers Pancreatic Canc...	GoC interventio...	21 Years -	Icahn School of Medicine at Mount Sinai
Post SBRT Pulmonary Metastasectomy (PSPM) Trial	NCT04160143	Surgical Resect... Stereotactic Bo... Lung Cancer Pulmonary Metas...	Surgical resect...	18 Years -	McMaster University
Improving Goals of Care Discussion in Advanced Cancer Patients	NCT02374255	Primary Stage I... Esophageal Colorectal Canc... Glioblastoma Cancer of Stoma... Cancer of Pancr... Melanoma Head or Neck Ca... Stage III Stage IV Lung Cancers Pancreatic Canc...	GoC interventio...	21 Years -	Icahn School of Medicine at Mount Sinai

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